dreamcatcher
- 11 Sep 2012 21:55
dreamcatcher
- 11 Sep 2012 22:21
- 2 of 213
Summit Corporation PLC : Technology License Agr...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT ENTERS TECHNOLOGY LICENSE AGREEMENT WITH BRISTOL-MYERS SQUIBB
Oxford, UK, 11 September 2012 - Summit (AIM: SUMM), a UK drug discovery company, today announces that it has entered a technology license agreement with Bristol-Myers Squibb Company (NYSE: BMY) under which Bristol-Myers Squibb will use Summit's proprietary Seglin(TM) technology to identify and develop drug candidates for up to ten targets across multiple therapeutic areas.
"Summit is pleased to be partnering with one of the world's premier biopharmaceutical companies," commented Glyn Edwards, Chief Executive Officer of Summit. "This agreement with Bristol-Myers Squibb further reinforces our strategy as we seek alternative ways to realise the value of our Seglin technology while we concentrate our resources on advancing our core Duchenne Muscular Dystrophy and C. difficile programmes."
Under the terms of the agreement, Bristol-Myers Squibb will be responsible for the discovery stage research and will have the exclusive right to develop and commercialise any Seglin products that are identified. Summit will receive a $100,000 technology access fee and is eligible for research, development and regulatory milestones of up to $30 million per product, plus royalties on worldwide sales of products arising from the technology.
Notes to Editors
About Seglin(TM) Technology
In human biology, the function of cells, tissues, pathways and physiological systems is fundamentally dependent on proteins, nucleic acids, carbohydrates and lipids. The importance of proteins and nucleic acids is well established in drug discovery but the targeting of carbohydrate biology remains largely underexploited. Seglin(TM) technology is an innovative drug discovery platform that aims to address this by using appropriate new chemistry space to access these carbohydrate drug targets. Seglins are orally available small molecules that act as carbohydrate mimics meaning they are ideally placed to exploit new carbohydrate related drug targets.
About Summit
Summit is an Oxford, UK based drug discovery Company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com.
dreamcatcher
- 11 Sep 2012 22:30
- 3 of 213
Summit inks breakthrough Seglin deal with Bristol-Myers Squibb
7:05 am by Ian Lyall In C1100, the group has a potentially breakthrough treatment for Duchenne Muscular Dystrophy. Its second major discovert, SMT 19969, is a highly potent anti-biotic designed to tackle the hospital superbug C.difficile.
Summit Corp (LON:SUMM) this morning unveiled a collaboration with one of the world’s largest pharmaceuticals companies that could eventually be worth US$30 million per product in research, development and regulatory milestone payments
http://www.proactiveinvestors.co.uk/companies/news/47935/summit-inks-breakthrough-seglin-deal-with-bristol-myers-squibb-47935.html
dreamcatcher
- 11 Sep 2012 22:35
- 4 of 213
:-))
dreamcatcher
- 12 Sep 2012 15:41
- 5 of 213
Summit chief says Bristol-Myers partnership "a fantastic deal"
11:56 am by Ian Lyall It is hoped these second generation immunosugars will provide a radical new platform to develop drugs for illnesses such as Alzheimers Shares in Summit Corp (LON:SUMM) consolidated on the strong gains made yesterday as investors digested the huge potential of the drug developer’s tie-up with one of the world’s largest pharmaceuticals companies.
The deal with Bristol-Myers Squibb could be worth as much as US$30 million per product, but the US giant will initially pay US$100,000 fee to access the company’s Seglin technology.
It is hoped these second generation immunosugars will provide a radical new platform to develop drugs for illnesses such as Alzheimers.
The importance of proteins and nucleic acids is well established in drug discovery, but the targeting of carbohydrate biology remains largely underexploited.
Seglin technology hopes to redress the balance.
The partnership is part of the re-focused strategy set out by chief executive Glyn Edwards.
Last week he revealed he wanted “someone else to pick up the heavy lifting” on the exciting Seglin programme, which is still in the very early phase of development, to allow the company to focus on their two key drug candidates.
In C1100, the group has a potentially breakthrough treatment for Duchenne Muscular Dystrophy. Its second major discovery, SMT 19969, is a highly potent anti-biotic designed to tackle the hospital superbug C.difficile.
Speaking from California, where he is attending a micro-biology conference and “talking about our c.diff product”, Edwards gave an upbeat assessment of the BMS tie-up.
“I think it is a really good deal. It shows a major pharmaceuticals company really values the technology,” he told Proactive Investors.
He revealed the Americans will initially use the Seglin technology to assess the potential of as many as 10 drug targets, making it a far broader collaboration than the headline suggests.
There is also the capacity to bring in other partners interested in using the platform to develop their own drug candidates.
And the group retains ownership of its OGA, or O-linked N-acetylglucosaminidase programme, which segues very neatly into the latest research on Alzheimer’s.
It is expecting further data from this study by the end of the year after which it will look for partners.
In the meantime the Bristol-Myers agreement reveals Summit can extract a substantial amount of value from so-called non-core assets.
“When we made our announcement last week and we said we wanted to focus on DMD and c.diff, this wasn’t because we didn’t think the other programmes weren’t worth anything,” said Edwards.
“It was more a case that we couldn’t get full value because we couldn’t put the full resource behind it.
“What this deal does is put the resources of a major pharma company behind the technology we can’t invest in.
“We retain some significant upside. They do the work and if they are successful they make some significant payments to us.
“So to me it is a fantastic way of exploiting the technology without having to put any money into it.
“They [BMS] have 10 targets for diseases they are going screen against.
“That means there could be ten products and each of those could give up to US$30 million in milestones and royalties on top of that. It really is a fantastic deal.”
At midday the stock was up 2 per cent at 3.32 pence, having advanced more than 30 per cent on Tuesday.
js8106455
- 13 Sep 2012 15:37
- 6 of 213
Interesting audio interview with Dr Glyn Edwards, Chief Executive Officer.
Click on the link to listen:
http://www.brrmedia.co.uk/event/104107/dr-glyn-edwards-chief-executive-officer
dreamcatcher
- 21 Sep 2012 15:05
- 7 of 213
Nice 8% rise today
skyhigh
- 21 Sep 2012 18:07
- 8 of 213
Yep, long may it continue!
dreamcatcher
- 24 Sep 2012 09:11
- 9 of 213
It is today, up 7%
dreamcatcher
- 24 Sep 2012 12:03
- 10 of 213
up 14.81%
dreamcatcher
- 25 Sep 2012 07:25
- 11 of 213
dreamcatcher
- 25 Sep 2012 15:19
- 12 of 213
UPDATE: Summit c.diff drug to go in phase I trials; pre-clinical data very encouraging
1:52 pm by Ian Lyall UPDATE: Summit c.diff drug to go in phase I trials; pre-clinical data very encouraging --ADDS SHARE PRICE AND BROKER COMMENT---
Summit Group (LON:SUMM) said it has been given the go ahead to take its c.difficile drug candidate into phase I clinical trials as it released early stage data that give a hint to its huge potential.
The latest announcement comes exactly a fortnight after Summit signed drugs giant Bristol Myers Squibb to partner its second generation immunosugars programme, which could provide a radical new platform to develop drugs for illnesses such as Alzheimer’s.
And it is less than a month since chief executive Glyn Edwards unveiled a fundamental shake-up in the way the company will operate.
All of this suggests a step change in the pace of development at Summit.
The Medicines and Healthcare products Regulatory Agency approval means SMT 19969 is on track to go into phase I trial by the end of the year with results expected to be reported in the first half of next. It will assess the safety and tolerability of the 19969, which is taken by mouth, and it will also look into what the body does to the drug. This early stage study won’t assess efficacy.
However Summit said it will present pre-clinical data to the One Bug, One Drug conference being held in Cambridge later today that will show 19969 has the potential to overcome the limitations associated with existing antibiotics used to treat c.diff.
In non-clinical efficacy studies, it combines potent activity against c. difficile with exceptionally high levels of antibacterial selectivity, Summit revealed this morning.
Importantly, it demonstrates efficacy in two key disease models and complete protection against recurrent disease.
In addition, the treatment is targeted to the gastrointestinal tract, the site of infection, and has “exceptionally low levels of resistance development while maintaining an excellent safety profile”, the early data reveal.
“Summit is pleased to receive regulatory approval to commence clinical trials of SMT 19969 as we are excited about its potential as a treatment for C. difficile infections,” said CEO Edwards.
“SMT 19969 is a narrow-spectrum antibiotic being specifically developed to treat this serious illness and the compelling package of preclinical data being presented today highlights that it has an ideal profile to protect against recurrent disease; the key clinical issue associated with this illness."
Shares in the company rose by as much as 7 per cent in early trade, but succumbed to a bout of profit-taking. At 2pm the stock was changing hands for 3.6 pence, down 0.03 pence on the day.
In the past month the stock has gained almost 30 per cent.
“We reiterate our positive view on the stock and eagerly await further progress,” said the company’s broker Singer Capital Markets in a short note to clients.
dreamcatcher
- 26 Sep 2012 15:15
- 13 of 213
Up 10%
dreamcatcher
- 05 Oct 2012 14:13
- 14 of 213
UP 7% good buying
dreamcatcher
- 08 Oct 2012 17:18
- 15 of 213
Good to see this back at 8p, on the way
skyhigh
- 10 Oct 2012 11:36
- 16 of 213
It's getting there! Good news released this morning :)
dreamcatcher
- 17 Oct 2012 18:37
- 17 of 213
Summit Corporation PLC Positive Phase 1 Trial Results for SMT C1100 for DMD
TIDMSUMM
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT ANNOUNCES POSITIVE PHASE 1 TRIAL RESULTS FOR SMT C1100 FOR TREATMENT OF
DUCHENNE MUSCULAR DYSTROPHY
Oxford, UK, 10 October 2012 - Summit (AIM: SUMM), a UK drug discovery company,
announces positive top-line results from a Phase 1 clinical trial of SMT C1100
for the treatment of Duchenne Muscular Dystrophy ('DMD'), a fatal muscle wasting
disease for which there is currently no cure. SMT C1100, an oral small
molecule, is a potential disease modifying drug that works to increase or
upregulate the amount of a naturally occurring protein called utrophin. These
data will be presented at the 17(th) Annual Congress of the World Muscle
Society, 9-13 October 2012, Perth Australia.
The Phase 1 dose-escalating trial was conducted in healthy volunteers and
evaluated a new aqueous formulation of SMT C1100. The trial met its primary
endpoints with results showing the formulation to be safe and well tolerated at
all doses. Importantly, the new formulation also demonstrated improved levels
of bioavailability (absorption) of the drug that were above those anticipated to
be needed to achieve clinical efficacy. These results are strongly supportive
for the progression of SMT C1100 into patient clinical trials.
"The positive outcome from this Phase 1 trial is a significant step forward for
DMD and our utrophin upregulator drug SMT C1100," commented Glyn Edwards, Chief
Executive Officer of Summit. "Utrophin upregulation is an important mechanism
for treating DMD as it is expected to have broad applicability for all patients
regardless of the specific genetic fault causing their disease. We are highly
encouraged that the new formulation of SMT C1100 shows improved bioavailability
as we believe it supports the progression of this potential breakthrough
treatment into DMD patient clinical trials."
The double-blind, placebo-controlled trial examined single and multiple
ascending oral doses of a nanoparticle aqueous suspension formulation of SMT
C1100 in a total of 48 healthy volunteers. When single doses were increased from
50mg/kg up to 400mg/kg, SMT C1100 blood plasma levels were increased for several
hours above those required to give a 50% increase in utrophin levels in vitro
measured in cells taken from DMD patients. In addition, the new formulation
resulted in higher blood plasma concentrations of SMT C1100 when compared with
results from a previous Phase 1 healthy volunteer study that used a different
formulation. Analysis of the multiple ascending dose groups remains on-going
and results are expected to be reported later this year.
A copy of the presentation being given at the World Muscle Society Congress will
be available from Summit's website, www.summitplc.com.
The Phase 1 trial has been supported by a group of US DMD foundations: the
Muscular Dystrophy Association, Charley's Fund, Cure Duchenne, the Foundation to
Eradicate Duchenne, Nash Avery Foundation and Parent Project Muscular Dystrophy.
Notes to Editors
About SMT C1100
SMT C1100 is designed to upregulate and maintain the production of utrophin.
Utrophin is a protein that is highly expressed in foetal and regenerating
muscle but decreases as the muscle fibre mature and is eventually replaced by
dystrophin, a similar protein that maintains the integrity and healthy function
of muscles. Patients with DMD are unable to make dystrophin, resulting in
muscle fibre degeneration. However, if utrophin is continually expressed in the
mature fibre, it can functionally replace dystrophin and is expected to overcome
the deficit in patients with DMD. This approach is expected to be a universal
treatment for all DMD patients regardless of whether the disease was caused by
an inherited or spontaneous mutation. Summit has demonstrated in non-clinical
efficacy studies that SMT C1100 is capable of increasing utrophin to restore and
maintain the healthy function of muscles including the heart and diaphragm. SMT
C1100 has been granted orphan drug status in Europe and the US.
About Summit
Summit is an Oxford, UK based drug discovery Company targeting high-value areas
of unmet medical need including Duchenne Muscular Dystrophy and C. difficile
infection. Summit is listed on the AIM market of the London Stock Exchange and
trades under the ticker symbol SUMM. Further information is available at
www.summitplc.com.
- END -
Latest Presentations
17th World Muscle Society Congress
9th-13th October 2012
Presentation of top-line results from Phase I trial of SMT C1100 for treatment of ...
http://www.summitplc.com/userfiles/file/SMT%20C1100%20WMS%20poster%20FINAL%202.pdf
dreamcatcher
- 22 Oct 2012 07:05
- 18 of 213
Summit Corporation PLC : £4.0 million Awar...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT AWARDED UP TO £4.0 MILLION FROM THE WELLCOME TRUST TO SUPPORT CLINICAL DEVELOPMENT OF SELECTIVE C. DIFFICILE ANTIBIOTIC
Oxford, UK, 22 October 2012 - Summit (AIM: SUMM), a UK drug discovery company, is pleased to announce that it has extended its partnership with the Wellcome Trust through a translational research award worth up to £4.0 million ($6.5 million) to support the development of SMT 19969 to clinical proof of concept studies. SMT 19969 is a novel, oral small molecule being developed as a specific antibiotic for the treatment of infections caused by C. difficile.
"Summit is delighted to extend its partnership with the Wellcome Trust to support the development of one of our core programmes," commented Glyn Edwards, Chief Executive Officer of Summit. "This Wellcome Trust award endorses the potential of SMT 19969, our promising antibiotic for the treatment of serious infections caused by C. difficile bacteria, and will provide non-dilutive funding to de-risk its development as it advances through important clinical milestones."
"C. difficile infection represent a serious healthcare threat and this £4.0 million translational award underlines the Wellcome Trust's commitment to supporting the development of new and effective antibiotic treatments," commented Ted Bianco, Director of Technology Transfer at the Wellcome Trust. "We are pleased to be extending our successful partnership with Summit and look forward to testing in the clinic the potential of the SMT 19969 drug."
Under the terms of the award, Summit will be eligible for up to £4.0 million in staged, success-based payments. Summit will immediately receive £1.26 million that will support a Phase 1 clinical trial in healthy volunteers and additional non-clinical studies designed to enhance the clinical data package. The Phase 1 trial is expected to commence by the end of 2012 with results expected in H1 2013. A successful outcome would trigger a further three payments from the Wellcome Trust with these contributing significantly towards undertaking a Phase 2 proof of concept trial in patients.
The award is being made as part of the Wellcome Trust's Translation Award programme. This represents the second funding award the Wellcome Trust has made to support Summit's C. difficile antibiotic programme and follows an award made under the Seeding Drug Discovery Initiative in 2009. A new funding agreement has been signed under which the Wellcome Trust share in net revenues generated by commercialisation of the programme.
Notes to Editors
dreamcatcher
- 22 Oct 2012 17:49
- 19 of 213
Summit boss says Wellcome Trust deal provides "huge validation" of C.diff programme
11:32 am by Ian Lyall Earlier, the drug discovery group said it will receive staged payments, starting with £1.26 million that will support the phase I trial of its new antibiotic as well as “additional non-clinical studies” Summit’s (LON:SUMM) partnership with medical charity Wellcome Trust provides “huge validation” of the drug developer’s C.difficile programme as well as delivering a major source of non-dilutive financing, says boss Glyn Edwards.
He also revealed the cash injection of up to £4 million would allow the group to push the antibiotic, called SMT 19969, through the first two phases of clinical trials before it has to seek a commercial partner.
“Obviously if Wellcome is excited about this drug then other pharma partners are going to be excited about it,” the Summit chief executive added.
“What this means is we will be under no pressure to do an early deal that doesn’t reflect the full value of the programme because we have the firepower to take it to the end of phase II on our own, which is stunningly good.”
Earlier, the drug discovery group said it will receive staged payments, starting with £1.26 million that will support the phase I trial of its new antibiotic as well as “additional non-clinical studies”.
The phase I is set to begin by the end of the year with results expected by mid-2013.
Success in this early study would open the door to a further three payments from that would “contribute significantly towards undertaking a phase II proof of concept trial in patients”.
The award is being made as part of the Wellcome Trust's Translation Award programme.
This represents the second contribution made by Britain’s leading scientific organisations towards the AIM-listed biotech’s C.difficile antibiotic programme.
“It is a good deal in two main aspects: the first is validation of the product,” said Edwards.
“Wellcome is a huge funder of basic science in this area. This is one of the biggest awards they have ever given under this translation award scheme.
“And it is a huge validation that Wellcome has looked at the science behind the product and decided to make what, for them, is a fairly substantial award.
“It is huge validation of the approach we are taking. Any drug development is risky. But this has got the stamp from one of the world’s leading research organisations.
“The second part is the amount of cash we are receiving for the programme. It not only funds the phase I, which we had already raised money to do. It also makes a substantial contribution towards funding a phase II.
“From an equity point of view it is non-dilutive funding and has a major impact on the balance sheet.”
Summit raised around £5 million earlier this year and set aside around £1.5 million to complete a phase I trial on healthy volunteers.
The addition of the Wellcome money allows the group to push C.difficile into phase II and concentrate on how it will fund second stage clinical trials for SMT C1100, its flagship drug candidate for Duchenne Muscular Dystrophy. DMD is a fatal muscle wasting that affects only boys.
Earlier this month it cleared a “massive hurdle” with the release of positive phase I clinical data that showed SMT C1100 was safe and well tolerated at all doses.
Crucially it also revealed the drug was absorbed into the bloodstream at levels that would make it efficacious.
A previous formulation produced by Summit’s former partner BioMarin failed in this regard.
Where C1100 was originally suspended in corn oil, Summit scientists appear to have avoided problems by producing a nano-particulate suspended in water.
The next results, due before the year-end, will assess the safety signals from multiple doses of the treatment.
Assuming similar results the group will make preparations to take it into the phase II, the first patient study.
NASDAQ-listed Sarepta Therapeutics (NASDAQ:SRPT) scored some success recently when it revealed its potential treatment for DMD had shown signs of efficacy.
Edwards described this development and progress being made by Sarepta and another drug developer, Prosensa, as “exciting for the DMD community”.
But he added that C1100 may have even wider applications than the other drug candidates.
“There is definitely a feeling that DMD is still an area that has huge issues, but we are starting to make progress,” said Edwards.
“There is real optimism in the DMD space.”
dreamcatcher
- 28 Oct 2012 16:17
- 20 of 213
Its a small british-based biotechnology company developing a potentially exciting new treatment for Duchenne muscular dystrophy,a rare genetically inherited, muscle-wasting condition. The first clinical results for its drug candidate are expected towards the end of the year. Its a high-risk project - the company's stockmarket valuation suggests investors are already discounting failure- yet it could surprise everyone.
dreamcatcher
- 31 Oct 2012 15:25
- 21 of 213
Note - Streaming News is only available to subscribers to the Active Level and above
Summit Corporation PLC : Initiation of Phase 1 ...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT ANNOUNCE INITIATION OF PHASE 1 CLINICAL TRIAL OF SELECTIVE ORAL ANTIBIOTIC FOR THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 31 October 2012 - Summit (AIM: SUMM), a UK drug discovery company, announces that it has initiated dosing of healthy volunteers in the Phase 1 clinical trial of SMT 19969, the novel, oral small molecule being developed as a selective antibiotic for the treatment of infections caused by the bacteria C. difficile. The trial is being supported as part of a £4.0m Translation Award from the Wellcome Trust.
"C. difficile infection remains a serious illness in hospitals, long-term care homes and increasingly the wider community, and current treatment options remain limited," commented Glyn Edwards, Chief Executive Officer of Summit. "Our novel antibiotic SMT 19969 is a selective treatment of C. difficile infection and we are very excited about advancing this promising drug into human clinical trials."
The Phase 1 trial is a randomised, dose-escalating, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics of SMT 19969. The study will enrol 56 healthy volunteers who will be divided into several cohorts and will receive single ascending doses and multiple ascending doses of SMT 19969. Headline results from the Phase 1 trial are expected to be reported in H1 2013.
Notes to Editors
About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness that is caused by infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that disrupt the normal gastrointestinal (gut) flora and so allow the C. difficile bacteria to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.
About SMT 19969
SMT 19969 is a novel, oral small molecule antibiotic that is being specifically developed for the treatment of CDI. Results from non-clinical efficacy studies show that SMT 19969 combines potent activity against C. difficile with exceptionally high levels of antibacterial selectivity. This narrow spectrum antibiotic has displayed efficacy in two key disease models while showing complete protection against recurrent disease. SMT 19969 is targeted to the GI tract, the site of infection, and has exceptionally low levels of resistance development coupled with an excellent safety profile.
About Summit
Summit is an Oxford, UK based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and follow Summit on Twitter (@summitplc).
About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk
- END -
For more information, please contact:
dreamcatcher
- 07 Nov 2012 07:09
- 22 of 213
Summit Corporation PLC : Repeat Dosing of SMT C...
HUG
Summit Corporation plc
('Summit' or 'the Company')
REPEAT DOSING OF SMT C1100 FOR TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY MEETS ENDPOINTS IN PHASE 1 CLINICAL TRIAL
New formulation delivers drug levels that are predicted to significantly increase utrophin production
Summit to progress utrophin upregulator into next stages of development
Oxford, UK, 7 November 2012 - Summit (AIM: SUMM), a UK drug discovery company, announces that the repeat dosing of the utrophin upregulator SMT C1100 for the treatment of the fatal muscle-wasting disease Duchenne Muscular Dystrophy ('DMD') has successfully met the endpoints as part of a Phase 1 clinical trial in healthy volunteers. The trial evaluated a new formulation of SMT C1100 and the results showed that upon repeat dosing, concentrations of the drug achieved in the blood plasma, stabilised at levels that from preclinical studies are expected to significantly increase utrophin protein production. The new formulation was also shown to be safe and well-tolerated in this Phase 1 trial.
SMT C1100 is a potential disease-modifying, oral small-molecule that works by upregulating (increasing) the amount of a naturally occurring protein called utrophin to maintain the healthy function of muscles. These data strongly support the progression of SMT C1100 into the next stages of development that includes biomarker and long-term safety studies, which will be required before a DMD patient efficacy trial could commence. The latest results will be presented at the 2012 Action Duchenne Conference, 9-10 November, London UK.
"Utrophin upregulation is a unique approach for treating DMD because it could benefit all DMD patients, regardless of their underlying genetic fault," commented Glyn Edwards, Chief Executive Officer of Summit. "We are highly encouraged by these results, as the new formulation achieves blood concentrations that have the potential to significantly increase utrophin levels, with the outcome of maintaining the healthy function of muscles in patients with DMD. The results therefore strongly support continuing clinical evaluation of SMT C1100."
The double blind, placebo-controlled Phase 1 trial examined a new nanoparticle aqueous suspension of SMT C1100 in a total of 48 healthy volunteers. The previously reported results from the single ascending dose cohort showed SMT C1100 to be safe and well-tolerated at all doses. These new data are being reported from the repeat dosing cohort where the volunteers received 100mg/kg twice daily for nine days. These results show that in all volunteers the blood plasma concentration of SMT C1100 stabilised after four days of dosing above the required level expected to increase utrophin protein production by 50% for at least 14 hours a day in a preclinical model. The plasma levels achieved were equivalent to those that gave significant therapeutic benefit in the gold standard disease model of DMD.
A copy of the presentation being given at the Action Duchenne conference will be available on Summit's website after the event.
The Phase 1 trial has received funding from a group of US DMD foundations: the Muscular Dystrophy Association, Charley's Fund, Cure Duchenne, the Foundation to Eradicate Duchenne, Nash Avery Foundation and Parent Project Muscular Dystrophy.
About SMT C1100 & Utrophin Upregulation
SMT C1100 is designed to upregulate and maintain the production of utrophin. Utrophin is a protein that is highly expressed in foetal and regenerating muscle but decreases as the muscle fibre mature and is eventually replaced by dystrophin, a similar protein that maintains the integrity and healthy function of muscles. Patients with DMD are unable to make dystrophin, resulting in muscle fibre degeneration. However, if utrophin is continually expressed in the mature fibre, it can functionally replace dystrophin and is expected to overcome the deficit in patients with DMD. This approach is expected to be a universal treatment for all DMD patients regardless of whether the disease was caused by an inherited or spontaneous mutation. Summit has demonstrated in non-clinical efficacy studies that SMT C1100 is capable of switching utrophin production back-on to restore and maintain the healthy function of muscles including the heart and diaphragm. SMT C1100 has been granted orphan drug status in Europe and the US.
About Summit
Summit is an Oxford, UK based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and follow Summit on Twitter (@summitplc).
dreamcatcher
- 07 Nov 2012 15:13
- 23 of 213
Good day for summit up 10%
dreamcatcher
- 07 Nov 2012 15:29
- 24 of 213
Summit shares surge following latest, highly encouraging update on DMD drug study
12:15 pm by Ian LyallThe initial market reaction was muted, though in the latter part of the morning a spike in buying activity sent the share price 0.65 pence higher to 5.65 pence.
Shares in Summit (LON:SUMM) rose 13 per cent after the drug developer unveiled highly encouraging results from the repeat dosing of its SMT C1100 treatment for Duchenne Muscular Dystrophy.
The phase I trial, which supports C1100’s transition into the next phase of clinical studies, revealed that concentrations of the drug were detected at levels that expected to significantly increase utrophin protein production.
This is important on two levels. First the group hopes to use utrophin to compensate for the lack of dystrophin that is at the root of DMD.
It also potentially offers a means to treat all suffers of this fatal, but thankfully rare condition that only affects boys.
DMD is caused by mutations in the dystrophin gene. This gene contains the instructions for making dystrophin protein, which acts as a shock absorber to prevent damage when muscles contract.
It is thought that utrophin, a protein naturally present in the body in small amounts, may be able to make up for the lack of dystrophin in boys with DMD since both proteins are structurally similar and appear to have very similar functions.
“Utrophin upregulation is a unique approach for treating DMD because it could benefit all DMD patients, regardless of their underlying genetic fault,” said Glyn Edwards, chief executive of Summit.
“We are highly encouraged by these results, as the new formulation achieves blood concentrations that have the potential to significantly increase utrophin levels, with the outcome of maintaining the healthy function of muscles in patients with DMD.
“The results therefore strongly support continuing clinical evaluation of SMT C1100. The company said the latest data strongly support the drug’s transition into the next phase of clinical studies.”
The initial market reaction was muted, though in the latter part of the morning a spike in buying activity sent the share price 0.65 pence higher to 5.65 pence.
The stock has more than doubled in value since the start of September.
N+1 Singer was encouraged by the latest update from the company. Analyst Sheena Berry said: “The data provides strong support for the further development of C1100 as a novel treatment for DMD, a fatal muscle wasting disease with no current cure.
“Unlike other approaches in development, C1100 can potentially by used to treat 100 per cent of boys with DMD and in combination with other agents.”
The news has come thick and fast in the past six weeks for Summit, which has enjoyed clinical success as well as sealing deals with drugs giant Bristol-Myers Squibb and the Wellcome Trust charity.
Meanwhile, last week it revealed it begun the dosing stage of a phase 1 clinical trial of a potential antibiotic treatment for C.Difficile infections.
skyhigh
- 07 Nov 2012 16:41
- 25 of 213
Yep, nice one!
dreamcatcher
- 09 Nov 2012 15:03
- 26 of 213
dreamcatcher
- 20 Nov 2012 16:20
- 27 of 213
up 8%
dreamcatcher
- 20 Nov 2012 16:38
- 28 of 213
Proactive Investors One2One Investor Forum
22 November 2012, London UK
dreamcatcher
- 22 Nov 2012 08:37
- 29 of 213
Summit Corporation PLC : Summit Appoints Mr Jim...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT APPOINTS MR JIM MELLON AND DR FRANK ARMSTRONG AS NON-EXECUTIVE DIRECTORS
Oxford, UK, 22 November 2012 - Summit (AIM: SUMM), a UK drug discovery and development company, is pleased to announce that it has appointed Mr Jim Mellon and Dr Frank Armstrong as Non-Executive Directors. The addition of Mr Mellon and Dr Armstrong to Summit's Board of Directors is part of the Company's previously announced strategic shift to focus on its clinical-stage programmes for the treatment Duchenne Muscular Dystrophy (DMD) and C. difficile infections.
Mr Jim Mellon is a renowned investor and entrepreneur with interests in several industries. Jim is an active investor in the biopharmaceutical industry and is a Non-Executive Director of the UK biotechnology company, Plethora Solutions plc and of the biopharmaceutical investment company, Port Erin BioPharma plc.
Dr Frank Armstrong is an experienced, medically qualified Pharmaceutical Executive who has worked at Board level at a number of companies in the UK, US, Switzerland and Germany. He has extensive experience of all aspects of medical and product development in large and small companies and has led successful product approvals in the US and Europe across a range of therapeutic areas.
"Jim and Frank will bring considerable business, clinical and product development expertise to support the future growth of Summit," commented Dr Barry Price, Chairman of Summit. "We welcome them and look forward to their contributions and strategic guidance as we focus on advancing our high-value clinical programmes targeting Duchenne Muscular Dystrophy and C. difficile infections."
With the appointment of the new directors, Dr Richard Storer, Dr Andy Richards and Mr George Elliott will be stepping down from the Board effective immediately.
Dr Price continued, "On behalf of the Board, I would sincerely like to thank Dick, Andy and George for their contribution towards the development of Summit over many years. In a challenging environment, their efforts have been invaluable in establishing a firm foundation that the Board believes will support the future growth of the business and we wish them every success for the future."
About Jim Mellon
Mr. Jim Mellon (55) began his career in the United States and Hong Kong with GT Management and later Thornton Management (Asia) Limited. Jim co-founded Regent Pacific Group, Ltd and Charlemagne Capital Limited. He is currently Executive Chairman of Manx Financial Group plc and Speymill plc, Non-Executive Co-Chairman of Regent Pacific Group Ltd and West Africa Minerals Corporation and Non-Executive Chairman of Speymill Deutsch Immobilien Company plc. In addition, he is a Non-Executive Director of Charlemagne Capital Limited, Condor Resources plc, Polo Resources Limited and various other investment companies. He is also the Chairman of the private asset manager, the Burnbrae Group Limited.
Jim has also written a number of investment books including his latest publication about the biotechnology industry titled "Cracking the Code" and he is a graduate of Oxford University.
Galloway Limited, a company wholly owned by a trust of which Jim Mellon is a life tenant, has a beneficial interest in 25,000,001 Ordinary shares of the Company that represents approximately 7.1% of the issued share capital. No further disclosures are required under Rule 17 and Schedule 2(g) of the AIM Rules.
About Frank Armstrong
Dr. Frank Armstrong (55) has held Chief Executive roles with five biotechnology companies (public and private) one of which was Fulcrum Pharma, an AIM-listed Professional Services Company that was sold to Private Equity Investors in 2009. In 2007 he led the sale of 454 Life Sciences from CuraGen to Roche. Most recently, Frank led Medical Research and Innovation (MSI) at Merck Serono and previously was Head of Worldwide Product Development at Bayer and Senior Vice President of Medical Research and Communications Group at Zeneca.
With experience as a Non-Executive Director in the UK and US working with private and NASDAQ listed companies and as Chairman of a Charitable Institution, Frank has moved successfully between large and small companies during his career.
Dr Armstrong is currently Chairman of Xceleron Inc., Executive Chairman of Asceneuron, Non-Executive Director of Actino Pharma and a Member of the Scientific Advisory Board of Healthcare Royalty Partners. Dr Armstrong is a Fellow of the Royal College of Physicians. There are no further disclosures required under Rule 17 and Schedule 2(g) of the AIM Rules.
dreamcatcher
- 22 Nov 2012 12:53
- 30 of 213
UPDATE: Summit appoints Mellon and Armstrong to the board
11:37 am by Ian LyallThe two new appointments strengthen the board's business and industry ties.
---ADDS PRICE TARGET, BROKER COMMENT---
Drug discovery group Summit (LON:SUMM) said the entrepreneur and investor Jim Mellon is one of two new non-executive directors that have been appointed to the board.
The other is Frank Armstrong, a medically qualified doctor who has worked at board level on a number of pharmaceutical companies.
“Jim and Frank will bring considerable business, clinical and product development expertise to support the future growth of Summit,” said Summit chairman Dr Barry Price
“We welcome them and look forward to their contributions and strategic guidance as we focus on advancing our high-value clinical programmes targeting Duchenne Muscular Dystrophy [DMD] and C. difficile infections.”
Today’s is the latest in a flurry of announcements that are slowly changing the face of Summit.
It is successfully developing its two key treatments – for DMD and C.diff - and has forged impressive links with big pharma, as well as uncovering innovative and dilutive sources of funding.
Its progress is reflected in a share price that has almost doubled in value since September 10.
The shares, which have more than doubled in value in the last two months, rose 3% to 4.9 pence on the news.
However broker N+1 Singer reckons Summit “intrinsic value” is 13.3 pence a share.
Talking about today’s news, analyst Sheena Berry said: “We believe the appointment of Mellon and Armstrong supports the group’s change in focus and strengthens its position to progress the two programmes through clinical trials.
“We continue to believe that Summit is a high quality business in a strong position to penetrate its target markets, particularly given the recent stream of positive news flow regarding clinical trial progression.”
dreamcatcher
- 23 Nov 2012 16:02
- 31 of 213
dreamcatcher
- 26 Nov 2012 20:21
- 32 of 213
:-))
skyhigh
- 26 Nov 2012 21:02
- 33 of 213
I bought in @3.5p back in April...so I'm happy with the way it's going...onwards & upwards! QPP going well for me as well!
dreamcatcher
- 26 Nov 2012 21:26
- 34 of 213
Well done Sh.
dreamcatcher
- 27 Dec 2012 09:56
- 35 of 213
Summit Corporation PLC : Award of Share Options
HUG
Summit Corporation plc
('Summit' or 'the Company')
AWARD OF SHARE OPTIONS
Oxford, UK, 27 December 2012 - Summit (AIM: SUMM), a UK drug discovery and development company, today announces that on 24 December 2012 it granted Share Options over 10,000,000 shares to certain individuals at an exercise price of 4.25 pence per share. The options will vest subject to achieving certain performance conditions.
This share option award is part of Summit's strategic shift to focus on the development of its clinical-stage programmes for the treatment of Duchenne Muscular Dystrophy ('DMD') and Clostridium difficile infections ('CDI') and will help motivate and retain personnel who are key to the success of the respective programmes. The Board believes this award is aligned with the interests of all shareholders as the Company seeks to generate shareholder value.
The options will fully vest on the third anniversary of date of grant subject to achieving the performance condition of the average closing share price being equal to or greater than 8.0 pence in any period of 30 consecutive calendar days ending on or before the third anniversary. The options will lapse if the performance condition is not met by the third anniversary of date of grant.
The total number of options being awarded represents 2.8% of the Company's current issued share capital. There are no options being awarded to Executive Directors or Officers at this time.
Notes to Editors
About Summit
Summit is an Oxford, UK based drug discovery and development Company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com.
- END -
dreamcatcher
- 06 Feb 2013 07:06
- 36 of 213
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT AND CHILDREN'S NATIONAL MEDICAL CENTER ENTER UTROPHIN BIOMARKER COLLABORATION FOR DUCHENNE MUSCULAR DYSTROPHY
•
Collaboration Supported by Grant from Foundation to Eradicate Duchenne
Oxford, UK, 6 February 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infections, announces that it has entered into a collaboration with Dr Yetrib Hathout from Children's National Medical Center in Washington DC, for the development of utrophin biomarkers for DMD. The collaboration is being financially supported by a grant from the Foundation to Eradicate Duchenne and is part of a comprehensive biomarker programme being undertaken by Summit to advance its utrophin modulator programme for DMD. In late 2012, Summit reported that in a Phase 1 trial in healthy volunteers, its lead candidate SMT C1100 was safe and well-tolerated.
"We are delighted to be working with Dr Hathout on developing new biomarkers that will help advance our understanding of DMD while supporting the progress of Summit's utrophin modulator programme," commented Glyn Edwards, Chief Executive Officer of Summit. "Developing biomarker indicators capable of accurately measuring utrophin protein levels in muscle will be vital in helping to confirm the activity of our clinical candidate SMT C1100 in future patient trials. We thank the Foundation to Eradicate Duchenne for their continuing support in advancing this important medical research."
Joel Wood, President of the Foundation to Eradicate Duchenne added, "We are committed to ensuring that urgently needed treatments have the best possible chance of successfully progressing through clinical trials. As such, we are pleased to provide funding to support Summit's utrophin modulation programme, which is a novel and promising approach for treating all genetic forms of DMD."
DMD is caused by genetic mutations that prevent patients from making the structural protein dystrophin, which leads to progressive muscle wasting and is ultimately fatal. Summit is pioneering utrophin modulation to stimulate production of utrophin, a functionally similar protein to dystrophin that is expressed in foetal and regenerating muscle, and which has the potential to restore and maintain healthy muscle function. This disease modifying approach would benefit all DMD patients, regardless of the underlying genetic fault causing their illness. SMT C1100 is the Company's leading utrophin modulator drug and successfully completed a Phase 1 clinical trial in late 2012.
The development of new biomarkers that accurately quantify utrophin protein levels in DMD muscles will play an important role in providing evidence for the potential effectiveness of Summit's utrophin modulator drugs in future patient clinical trials. Dr Hathout, a Principal Investigator at the Center for Genetic Medicine Research at Children's National, will apply his expertise in cutting-edge proteomic techniques to develop a sensitive, robust mass-spectrometry based assay that can quantitatively measure utrophin protein levels in biopsies of DMD muscle. This collaboration is part of Summit's comprehensive biomarker programme developing a range of assays that will measure biological endpoints to demonstrate muscle benefit after treatment with small molecule utrophin modulators
dreamcatcher
- 06 Feb 2013 20:36
- 37 of 213
UPDATE: Summit teams up with Children's National Medical Center
1:30 pm by John Harrington This collaboration is part of Summit's comprehensive biomarker programme developing a range of assays that will measure biological endpoints to demonstrate muscle benefit after treatment with small molecule utrophin modulators.
-- Adds comments from chief executive and broker --
Summit (LON:SUMM) has received a boost to its Duchenne Muscular Dystrophy (DMD) project with a charitable foundation agreeing to fund part of its testing programme.
The company is teaming up with the highly respected Dr Yetrib Hathout from Children's National Medical Center in Washington DC to develop utrophin biomarkers for DMD.
The collaboration is being financially supported by a grant from the Foundation to Eradicate Duchenne and is part of a comprehensive biomarker programme being undertaken by Summit to advance its utrophin modulator programme for DMD.
Utrophin is a protein that exists in muscle cells, and Summit already has a drug in development – SMT C1100 – which is designed to increase utrophin production as a treatment for DMD.
In a Phase 1 trial in healthy volunteers last year, SMT C1100 was deemed safe and well-tolerated.
“Developing biomarker indicators capable of accurately measuring utrophin protein levels in muscle will be vital in helping to confirm the activity of our clinical candidate SMT C1100 in future patient trials," said Glyn Edwards, chief executive officer of Summit.
Speaking to Proactive Investors, Edwards said that since the company refocused last year on just two programmes – the DMD drug SMT C1100 and the C. difficile infection treatment SMT 19969 – progress has come on in “leaps and bounds”.
“One of the big next steps is to do a trial … to find out whether the drug works or not … but that covers a multitude of sins. You’ve got to have ways of measuring how effective the drug is, and because this is a new approach to the treatment for a disease that has got no cures at the moment, then the measurement side is having to be developed as well as the drug side,” Edwards explained.
For that you need biomarkers: biological molecules found in blood, other body fluids, or tissues that provide a sign of a normal or abnormal process, or the activity of a disease.
Edwards said that developing biomarkers is “the hot thing” in the pharmaceutical industry as they can be used to see how well the body responds to a treatment for a disease, but, unfortunately, no company has developed a new biomarker for DMD that Summit can piggy-back on.
Consequently, the company has to work with leading academics, such as Dr Hathout, who is a Principal Investigator at the Center for Genetic Medicine Research at Children's National. He will apply his expertise in proteomic techniques to develop a sensitive, robust mass-spectrometry based assay that can quantitatively measure utrophin protein levels in biopsies of DMD muscle.
Edwards said the company is delighted to be working with Dr Hathout, and with the collaboration being wholly financed by the US organisation, the Foundation to Eradicate Duchenne, today’s deal is a “win-win for everyone”.
DMD is caused by genetic mutations that prevent patients from making the structural protein dystrophin, which leads to progressive muscle wasting. Except in very few circumstances, the disease only affects boys.
Fortunately, the number of people suffering from the disease is relatively small – Edwards said there are known to be about 50,000 sufferers scattered across North America, Europe and Japan – but the price for an effective treatment that can extend and improve the quality of a patient’s life is potentially high.
“Keeping the maths simple, let’s say the cost of treatment is $100,000 a year. With 50,000 sufferers that’s a potential $5bn a year market opportunity,” Edwards noted.
That explains why Summit chose to focus on developing a treatment.
Summit is pioneering utrophin modulation to stimulate production of utrophin, a functionally similar protein to dystrophin that is expressed in foetal and regenerating muscle, and which has the potential to restore and maintain healthy muscle function. This disease modifying approach would benefit all DMD patients, regardless of the underlying genetic fault causing their illness, Summit says.
This collaboration is part of Summit's comprehensive biomarker programme developing a range of assays that will measure biological endpoints to demonstrate muscle benefit after treatment with small molecule utrophin modulators.
Edwards said the company is hopeful other charities will chip in to help with other aspects of the biomarker programme.
In a research note, Sheena Berry and Jens Lindqvist of broker N+1 Singer said: “This agreement is in line with the company’s plans for the further development of SMT C1100 as a novel treatment for DMD, a fatal muscle wasting disease with no current cure. Unlike other approaches in development, SMT C1100 can potentially by used by 100% of boys with DMD and in combination with other agents. We re-iterate a positive stance and 13.3p price target.”
Summit shares currently trade at 4.5p.
dreamcatcher
- 13 Feb 2013 07:09
- 38 of 213
Summit Corporation PLC : Research Update
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT FORMS ADVISORY BOARD TO SUPPORT DEVELOPMENT OF DUCHENNE MUSCULAR DYSTROPHY PROGRAMME
Oxford, UK, 13 February 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infections, announces the formation of an Advisory Board ('the Board') to support the scientific and clinical development of its utrophin modulator programme for the treatment of the fatal genetic disease DMD. The Board brings together six world-renowned scientists and clinicians with expertise in the field of neuromuscular diseases, and particularly DMD.
"We are absolutely delighted to have brought together these eminent thought leaders in neuromuscular diseases to form a world-class Advisory Board that will support our DMD programme," commented Glyn Edwards, Chief Executive Officer of Summit. "Their expertise brings a deep insight into the disease and will provide invaluable input into future patient clinical trials to support the progression of our utrophin modulation programme, including our lead candidate SMT C1100."
"Summit's utrophin modulation program is a very promising approach that offers the opportunity to treat all the genetic forms of DMD," added Dr Kenneth Fischbeck, NIH Distinguished Investigator and member of the Advisory Board. "I look forward to working with this outstanding group of clinicians and scientists, and contributing to the progress of Summit's DMD program as we explore the potential of utrophin modulation as an effective treatment for this disease."
The members of Summit's DMD Advisory Board are:
Kate Bushby, MD, Professor of Neuromuscular Genetics at Newcastle University, Deputy Director of MRC Centre for Neuromuscular Diseases at London and Newcastle. Professor Bushby, a clinical academic at one of the leading international neuromuscular centres, is involved in an extensive programme of research in neuromuscular diseases from basic molecular pathology to clinical studies. Professor Bushby is one of the founding coordinators of the TREAT-NMD network and is a member of the Scientific Advisory Committees of the French Muscular Dystrophy Association ('AFM'), Action Duchenne and Parent Project Muscular Dystrophy.
Kay E Davies, MA, DPhil, DBE, FMedSci, FRS, Dr Lee's Professor of Anatomy, Director MRC Functional Genomics Unit, and Associate Head of the Medical Sciences Division at the University of Oxford. Professor Davies has a long-standing research interest in neuromuscular diseases and is a pioneer of utrophin modulation as a therapeutic approach for the treatment of DMD. Professor Davies is Chair of Action Duchenne's Scientific Advisory Board, a member of the Science Committee of the Muscular Dystrophy Campaign and a Governor of the Wellcome Trust.
Kenneth H Fischbeck, MD, NIH Distinguished Investigator and Chief of the Neurogenetics Branch at National Institute of Neurological Disorders and Stroke ('NINDS'). Dr Fischbeck's research focuses on identifying the causes and mechanisms of hereditary neurological and neuromuscular diseases with a particular interest in muscular dystrophy. Dr Fischbeck serves on advisory boards for the Muscular Dystrophy Association and the French Muscular Dystrophy Association ('AFM').
Louis M Kunkel, PhD, Professor of Pediatrics and Genetics at Harvard Medical School, and Director of Program in Genomics at Boston Children's Hospital. Professor Kunkel is an internationally recognised geneticist whose research identified the gene and encoded protein dystrophin that is mutated in boys with DMD. Professor Kunkel has a longstanding interest in developing therapies for the muscular dystrophies. Professor Kunkel is Chairman of the Muscular Dystrophy Association's Scientific Advisory Committee.
Francesco Muntoni, MD, PhD, Chair of Paediatric Neurology at the Institute of Child Health, London, and Director of the Dubowitz Neuromuscular Centre at University College London. Professor Muntoni is a paediatric neurologist at the UK's largest paediatric neuromuscular centre of excellence and has a long standing interest in the clinical and molecular aspects of neuromuscular diseases including DMD. Professor Muntoni is a member of the Scientific Advisory Committee of the Italian Telethon and Chair of the Scientific Advisory Board of the Myotubular Trust.
H Lee Sweeney, PhD, William Maul Massey Professor, Chairman of Physiology, and Director of the Center for Orphan Disease Research and Therapy at the University of Pennsylvania's Perelman School of Medicine. Dr Sweeney is a physiologist whose research interests evaluate the possible causes and treatments of muscle diseases, with a particular focus on DMD. Dr Sweeney is the Senior Scientific Advisor to the Parent Project Muscular Dystrophy.
- END -
dreamcatcher
- 11 Mar 2013 07:44
- 39 of 213
Summit Corporation PLC : New Data Reported from...
HUG
Summit Corporation plc
('Summit' or 'the Company')
NEW DATA REPORTED FROM PRECLINICAL EFFICACY STUDY OF OGA INHIBITORS FOR THE TREATMENT OF ALZHEIMER'S DISEASE AND RELATED TAUOPATHIES
Improvement in symptoms of motor impairment, increased survival recorded
New data presented at International conference on dementia
Oxford, UK, 11 March 2013 - Summit (AIM: SUMM), a drug discovery and development company, reports new data from its OGA (O-linked N-acetylglucosaminidase) inhibitor programme for the treatment of tauopathies, a group of neurodegenerative diseases that includes Alzheimer's disease. The OGA inhibitors were evaluated in an in vivo disease model, with results showing trends to a positive impact on motor impairment symptoms and improved survival rates following daily oral dosing. These new data were presented at AD/PD(TM) 2013, the international conference on Alzheimer's and Parkinson's diseases held in Florence, Italy, 6-10 March.
"Following the strategic refocusing of Summit to commit all resources into advancing our two clinical-stage programmes, the completion of this study represents the natural conclusion of our involvement in this programme," commented Glyn Edwards, Chief Executive Officer of Summit. "The inhibition of the enzyme OGA has emerged as a potential new treatment paradigm for Alzheimer's disease and related tauopathies. These encouraging results further highlight the promise of the approach and of our OGA inhibitors, and will add greater depth to the scientific data package as we talk with perspective collaborators about taking this programme further into development."
Summary of Results from Preclinical Efficacy Study
The study evaluated the OGA inhibitors, previously identified using Seglin(TM) technology, in a transgenic tauopathy disease model to determine the effect that prolonged dosing had on motor impairments related to the disease and survival rates. The tauopathies are also characterised by reduced levels of O-GlcNAcylated tau protein and raised levels of hyper-phosphorylated tau protein. In summary, the results of daily oral dosing with the Seglin inhibitors for 10 weeks were:
A clear trend for reduced clasping, a clinical sign indicative of motor impairment, and improved survival rates compared to the untreated cohort;
A statistically significant increase in O-GlcNAcylated protein levels in the brain with the increased global levels maintained on repeat dosing to demonstrate that the OGA inhibitor accessed the brain compartment at therapeutically relevant concentrations;
No observed change in tau protein phosphorylation levels although this is consistent with precedent from the scientific literature;
No associated toxicity or adverse effects from prolonged dosing observed.
The full results were reported at AD/PD(TM) 2013 held in Florence, Italy, 6-10 March 2013, and a copy of the presentation is available from www.summitplc.com.
dreamcatcher
- 11 Mar 2013 07:49
- 40 of 213
Summit reveals encouraging early data for potential Alzheimer’s treatment
7:29 am by Ian LyallThe new data were presented at an Alzheimer's and Parkinson's diseases conference in Florence that ended yesterday.
Drug developer Summit (LON:SUMM) has unveiled encouraging new data on its OGA inhibitor emanating from a pre-clinical study of efficacy in Alzheimer’s and related diseases.
The inhibition of OGA, or O-linked N-acetylglucosaminidase, has emerged as a potential method of treating tauopathies, a group of neurodegenerative diseases that includes Alzheimer's.
The in-vivo (in animal) disease model pointed to a positive impact on motor impairment symptoms and improved survival rates following daily oral dosing.
These new data were presented at an Alzheimer's and Parkinson's diseases conference in Florence that ended yesterday.
The company’s focus on its two lead drug candidates – one for Duchenne Muscular Dystrophy, the other for c.difficile infection – means the group will look for a partner to take research further.
"Following the strategic refocusing of Summit to commit all resources into advancing our two clinical-stage programmes, the completion of this study represents the natural conclusion of our involvement in this programme," said Summit chief executive Glyn Edwards.
"The inhibition of the enzyme OGA has emerged as a potential new treatment paradigm for Alzheimer's disease and related tauopathies. “These encouraging results further highlight the promise of the approach and of our OGA inhibitors, and will add greater depth to the scientific data package as we talk with prospective collaborators about taking this programme further into development
dreamcatcher
- 11 Mar 2013 14:55
- 41 of 213
UPDATE: Summit reveals encouraging early data for potential Alzheimer’s treatment
2:29 pm by Ian LyallThe new data were presented at an Alzheimer's and Parkinson's diseases conference in Florence.
--adds broker update--
Drug developer Summit (LON:SUMM) has unveiled encouraging new data on its OGA inhibitor emanating from a pre-clinical study of efficacy in Alzheimer’s and related diseases.
The inhibition of OGA, or O-linked N-acetylglucosaminidase, has emerged as a potential method of treating tauopathies, a group of neurodegenerative diseases that includes Alzheimer's.
The in-vivo (in animal) disease model pointed to a positive impact on motor impairment symptoms and improved survival rates following daily oral dosing.
These new data were presented at an Alzheimer's and Parkinson's diseases conference in Florence in March.
The company’s focus on its two lead drug candidates – one for Duchenne Muscular Dystrophy, the other for c.difficile infection – means the group will look for a partner to take research further.
"Following the strategic refocusing of Summit to commit all resources into advancing our two clinical-stage programmes, the completion of this study represents the natural conclusion of our involvement in this programme," said Summit chief executive Glyn Edwards.
"The inhibition of the enzyme OGA has emerged as a potential new treatment paradigm for Alzheimer's disease and related tauopathies.
“These encouraging results further highlight the promise of the approach and of our OGA inhibitors, and will add greater depth to the scientific data package as we talk with prospective collaborators about taking this programme further into development."
Broker N+1 added that while the news highlights the potential the group has with its OGA inhibitors, it is not one of the main focuses of the group and adds little to the investment case.
N+1 is waiting for further news on the progress of its DMD and C.diff programmes, which could potentially generate “game changing” returns.
The broker has a 13.3p price target. Shares rose slightly to 4.26p
dreamcatcher
- 11 Mar 2013 17:11
- 42 of 213
Broker round-up part 2 including Summit, Archipelago, Orogen Gold and Herencia
3:20 pm by John Harrington Philip Whiterow
Encouraging data from Summit’s (LON:SUMM) OGA inhibitor programme for the treatment of tauopathies, a group of diseases that includes Alzheimer’s disease, highlights the potential the group has with its OGA inhibitors, says N+1 Singer.
The broker is not making any change to its forecasts for Summit, however, because the study is not one of the main focuses of the group, and so therefore has little impact on the investment case.
“We await further news on the progress of its DMD and C.diff programmes, which could potentially generate game changing returns. We re-iterate a positive stance and 13.3p price target,” the broker said.
3 monkies
- 11 Mar 2013 17:25
- 43 of 213
Looked at these for a long time but never ventured. Looks promising, mmmm!! Enjoy every ray of sunshine as it is minus one here and snow, freezing winds, so not nice. You are in the best place no thermals needed I would not think. Enjoy.
dreamcatcher
- 11 Mar 2013 17:49
- 44 of 213
Its beautiful here. ;-)) Mid 70's. Looks like your weather is going backwards , saw the snow on the television. Thanks 3m.
Its been a real winter at home this year, can only get better I hope.
dreamcatcher
- 15 Mar 2013 19:10
- 45 of 213
Closed up 16%
skyhigh
- 17 Mar 2013 15:42
- 46 of 213
Be nice to double from here wouldn't it ?
dreamcatcher
- 17 Mar 2013 15:47
- 47 of 213
Or even better that 90p back in 08.
skyhigh
- 17 Mar 2013 15:58
- 48 of 213
Well, you never know....
dreamcatcher
- 17 Mar 2013 16:02
- 49 of 213
Its all about keeping your nerve lol. The broker has a 13.3p target. This one does seem to move in the +8% to -8% range. Some more positive news and we will get there,
dreamcatcher
- 17 Mar 2013 17:23
- 50 of 213
On Friday, Summit Corporation PLC (SUMM:LSE) closed at 5.25, 35.98% below its 52-week high of 8.20, set on Mar 15, 2012.
As of Mar 15, 2013, the consensus forecast amongst 3 polled investment analysts covering Summit Corporation plc advises that the company will outperform the market. This has been the consensus forecast since the sentiment of investment analysts deteriorated on Feb 03, 2010. The previous consensus forecast advised investors to purchase equity in Summit Corporation plc.
skyhigh
- 17 Mar 2013 17:31
- 51 of 213
hmm..might be a good time to buy more ...will think on it...there are afew others I'm thinking of going in on IAE is one of them..
Do you hold any other shares DC?
dreamcatcher
- 17 Mar 2013 17:43
- 52 of 213
A lot at the moment, in most of of the stocks I have posted on. Some doing very well ie Wand, condor. A lot of them tend to drift back with lack of news one being edge resources, made a 100% + sold and back in again with the start of drilling. Been a great share that one. Had very good run the last few months. Just hope it lasts for all of us. Prefer being in the smaller company's
as the sp does move faster. There is more risk and if it goes right, more reward.
dreamcatcher
- 21 Mar 2013 07:47
- 53 of 213
Summit outlines next steps in development of potentially breakthrough treatment
7:31 am by Ian LyallMaking the case: The company said it plans to present its utrophin modulator programme at what it described as a “major international conference” being held later this spring.

The drug discovery group Summit (LON:SUMM) has outlined its plans to further develop a potentially breakthrough treatment for muscle wasting disorder Duchenne Muscular Dystrophy.
Its lead drug candidate SMT C1100 is expected to enter clinical trials in patients in the second half of the year.
The study will be split into two. One part will concentrate on determining whether the drug is safe and well tolerated by children while assessing its C1100’s pharmacokinetics - in layman’s terms what the drug actually does to the body.
The treatment is designed stimulate production of a protein call utrophin, similar to dystrophin, which regulates muscle tone and function. It is hoped C1100 will restore and maintain healthy muscle function.
The second part of the study is a phase II trial that will include clinical markers of muscle health as well as levels of utrophin expression.
The biomarker programme has begun and includes the collaboration with Children’s National Medical Center of Washington DC, funded by the DMD organisation, The Foundation to Eradicate Duchenne.
The company said it plans to present its utrophin modulator programme at what it described as a “major international conference” being held later this spring.
Chief executive Glyn Edwards said: “Summit has a unique opportunity to develop a high-value franchise in utrophin modulation, an innovative therapeutic approach for DMD that targets all genetic forms of this devastating disease.
“These clinical trials will be the first to evaluate utrophin modulation in patients, and they aim to quickly establish clinical proof of concept for SMT C1100 through the use of novel biomarkers developed to measure aspects of muscle health.
“The biomarker work, to be conducted side by side with our clinical development programme, will strengthen our DMD franchise and will enhance the commercial value of this asset.”
dreamcatcher
- 21 Mar 2013 17:00
- 54 of 213
First patient studies represent "significant acceleration" of plans, says Edwards
4:45 pm by Giles Gwinnett and Ian LyallThe treatment is designed to stimulate production of a protein called utrophin, similar to dystrophin, which regulates muscle tone and function. It is hoped C1100 will restore and maintain healthy muscle function
The first patient studies of Summit's (LON:SUMM) potentially breakthrough treatment for Duchenne Muscular Dystrophy (DMD) represents a "significant acceleration" in the development programme, says chief executive Glyn Edwards.
Lead drug candidate SMT C1100 is expected to enter clinical trials in patients in the second half of the year.
"I think there was a perception out in the market that we were not going to be getting into patients until next year but what we've announced here is that the first patient studies will be starting later this year, with more studies next year, obviously, but it's a significant acceleration of the programme from people's expectations," he explained to Proactive.
He said the firm had flagged up at the end of the last trial last year that it would take all of this year to get things ready for this next step but Edwards says hard work has brought this timeline forward.
As reported earlier, the study will be split into two.
One part will concentrate on determining whether the drug is safe and well tolerated by children while assessing its C1100’s pharmacokinetics - in layman’s terms what the drug actually does to the body.
The treatment is designed to stimulate production of a protein called utrophin, similar to dystrophin, which regulates muscle tone and function. It is hoped C1100 will restore and maintain healthy muscle function.
The second part of the study is a phase II trial that will include clinical markers of muscle health as well as levels of utrophin expression.
The biomarker programme has begun and includes the collaboration with Children’s National Medical Center of Washington DC, funded by the DMD organisation, The Foundation to Eradicate Duchenne.
The company also said earlier it plans to present its utrophin modulator programme at what it described as a “major international conference” being held later this spring.
Edwards told investors: “Summit has a unique opportunity to develop a high-value franchise in utrophin modulation, an innovative therapeutic approach for DMD that targets all genetic forms of this devastating disease.
“These clinical trials will be the first to evaluate utrophin modulation in patients, and they aim to quickly establish clinical proof of concept for SMT C1100 through the use of novel biomarkers developed to measure aspects of muscle health.
“The biomarker work, to be conducted side by side with our clinical development programme, will strengthen our DMD franchise and will enhance the commercial value of this asset.”
Shares dipped 0.92% to 5.375p.
skyhigh
- 21 Mar 2013 19:12
- 55 of 213
hopefully we'll see more & stronger broker notes/recommendations soon
dreamcatcher
- 09 Apr 2013 18:59
- 56 of 213
Summit schedules FY results
9 April 2013 | 14:59pm
StockMarketWire.com - Summit - a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infections - will announce its preliminary results for the year to the end of January on 11 April.
At 2:59pm: [LON:SUMM] share price was +0.01p at 4.38p
dreamcatcher
- 11 Apr 2013 10:52
- 57 of 213
Sold my holding
dreamcatcher
- 24 Apr 2013 15:36
- 58 of 213
Summit antibiotic reveals encouraging early potential
By Ian Lyall April 24 2013, 7:32am The Summit drug candidate is part of a new class of antibiotics that are high potency and selective for one particular infection – in this case the so-called super-bug C.diff.The Summit drug candidate is part of a new class of antibiotics that are high potency and selective for one particular infection – in this case the so-called super-bug C.diff.
Summit (LON:SUMM) has unveiled encouraging early results from clinical trials on the antibiotic it is developing for C.difficile.
The phase I study on 56 healthy patients revealed SMT 19969 is both safe and well tolerated in the doses that would be required to treat patients.
The Summit drug candidate is part of a new class of antibiotics that are high potency and selective for one particular infection – in this case the so-called super-bug C.diff.
Researchers assessed 19969’s potential to target infections by looking at the gut flora in the volunteers. They found that it was “highly sparing” of gut flora with only the clostridia bacterial family reduced to levels below the limit of detection.
"The positive safety and tolerability of SMT 19969 in this human phase I trial is a major success," said Summit chief executive Glyn Edwards.
"The results of the gut flora analysis are particularly encouraging because they indicate that SMT 19969 could target C. difficile without undermining the natural balance of gut flora.
“This reinforces our belief that SMT 19969 can become a breakthrough treatment for this life-threatening disease."
Professor Mark Wilcox, Consultant Head of Microbiology at the Leeds Teaching Hospitals NHS Trust, added: “It is very encouraging that in human volunteers SMT 19969 is highly sparing of gut flora.
“This offers promise as a much needed alternative treatment for this potentially serious disease."
dreamcatcher
- 12 Jun 2013 22:59
- 59 of 213
Summit Appoints Dr David Roblin as Chief Medica...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT APPOINTS DR DAVID ROBLIN AS CHIEF MEDICAL OFFICER
Oxford, UK, 12 June 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), is pleased to announce the appointment of Dr David Roblin as the Company's Chief Medical Officer ('CMO'). During an extensive career in the pharmaceutical industry, Dr Roblin has successfully developed drugs through clinical trials and market launch across several therapy areas including infectious and metabolic diseases.
"As one of Europe's leading experts in translational medicine, I am delighted David has joined Summit as Chief Medical Officer to strengthen our clinical development team", commented Glyn Edwards, Chief Executive Officer of Summit. "David brings considerable expertise in all aspects of drug development having been instrumental in the successful development of a number of important medicines. As our DMD and CDI drug programmes go through patient clinical trials, David will make a major contribution to their successful development."
Summit's new Chief Medical Officer, Dr David Roblin, added, "SMT C1100 and SMT 19969 are promising new drugs, based on innovative science, that have the potential to address medical and patient need and, as a result, become breakthrough treatments for two devastating diseases. I look forward to working with the high quality team at Summit and supporting the development of these programmes as they progress through patient clinical trials."
About Dr David Roblin MBBS, BSc, FRCP, MFPM
Dr David Roblin is a qualified medical doctor who after practicing medicine entered the pharmaceutical and biotechnology industry. He has extensive experience from an 18-year career in the industry during which he has been involved in the successful development of a number of important medicines in a range of therapy areas including infectious and metabolic diseases.
David has held a number of senior leadership roles at Pfizer and Bayer where he was involved in research, development and commercialisation. At Pfizer, he was Head of Research, Site Director and CMO for Europe R&D and he and his units were responsible for the development of several important and successful medicines. At Bayer, he was Head of Therapy Area for Anti-infectives where he was involved in the successful development of a number of antibiotics, including Avelox(TM) and Cipro(TM).
Having held a number of Executive and Non-Executive Board positions, David also has experience in commercial and R&D strategy, fundraising and securing non-dilutive grants from a various UK, European and US government bodies. He will divide his time between Summit and Creabilis SA where he is also CMO. He is currently a Director of Destiny Pharma and Bio-Industry Advisor to the National Office of Research Infra-structure in the Department of Health.
David previously practiced medicine at St George's and St Bartholomew's Hospital, London, holds a degree in Biochemistry (University of London) and is a Fellow of the Royal College of Physicians and Member of the Faculty of Pharmaceutical Physicians.
- END -
someuwin
- 12 Jun 2013 23:23
- 60 of 213
At the recent AGM, the company said that a successful Phase 2 trial of SMT19969 could be worth £300 - £400m.
Therefore...
* Successful SMT19969 Phase II should add at least £300m of value by end of 2014.
* £300m = share price of 85p.
* So, 20 bagger in 18 months (On C. Diff alone!)
* PLUS - DMD SMTC1100 ($multi-billion market).
* PLUS - 'Lottery ticket' BMS/Seglin research.
dreamcatcher
- 15 Jun 2013 13:17
- 61 of 213
dreamcatcher
- 17 Jun 2013 16:23
- 62 of 213
N+1 Singer kept its ‘buy’ rating and 9p target price on Summit Corporation (LON:SUMM) today.
It comes as the drug developer said the successful completion of phase I clinical trials on SMT 19969, its antibiotic for C.difficile, triggered a £740,000 payment from the Wellcome Trust medical charity.
“The group’s development progression remains on track and we remain positive on its future prospects,” the broker said.
http://www.proactiveinvestors.co.uk/columns/broker-spotlight/13277/broker-round-up-ii-ariana-resources-new-world-oil-gas-kryso-resources-summit-corporation-13277.html
skyhigh
- 17 Jun 2013 17:27
- 63 of 213
Sounds good..hopefully the sp will be a lot higher in 18months... still think this will tread water for the next year and then ..boom! (imho)... will top up at these levels in the meantime as funds become available
dreamcatcher
- 17 Jun 2013 18:14
- 64 of 213
looks good.
someuwin
- 28 Jun 2013 19:15
- 65 of 213
Looks VERY good.
Just needs some patience!
As Hybridan recently said...
"Untenable Discount
We believe the huge valuation gulf between Summit and its peers is unsustainable; if financial markets don’t appreciate this then we would expect strategic investors to grab the opportunity sooner or later."
dreamcatcher
- 03 Jul 2013 07:08
- 66 of 213
Placing to Raise GBP4.5M and Offer for Subscrip...
HUG
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
Summit Corporation plc
('Summit' or 'the Company')
PROPOSED PLACING AND OFFER FOR SUBSCRIPTION TO QUALIFYING SHAREHOLDERS AND NOTICE OF GENERAL MEETING
Oxford, UK, 3 July 2013 - Summit (AIM: SUMM), a drug discovery and development company announces a share issue to raise GBP4.5 million (before expenses) through the issue of 90,750,000 new Ordinary Shares by way of a Placing at 5.0 pence per Ordinary Share to certain institutional investors and Directors. The Placing is being fully underwritten by Nomura Code Securities Limited on, and subject to, the terms of a placing agreement between the parties.
The issue price represents a premium of approximately 17.6 per cent. to the price of 4.25 pence per share, being the closing mid-market price of the Company's Ordinary Shares on 2 July 2013.
Glyn Edwards, Chief Executive Officer of Summit commented: "We are pleased to have received the support of existing shareholders and experienced healthcare investors in this placing that will maintain the development of our DMD programme while our novel C. difficile antibiotic continues to be supported by the Wellcome Trust."
Qualifying Shareholders will also be given an opportunity to participate in an Offer for Subscription of new Ordinary Shares at 5.0 pence per new Ordinary Share to raise up to GBP1.0 million in addition to the funds raised from the Placing.
A circular relating to the Placing and the Offer for Subscription will be posted to shareholders today. The circular contains a Notice of General Meeting to approve, inter alia, the issuance of the new Ordinary Shares pursuant to the Placing and the Offer for Subscription. The meeting will be held at the offices of Fasken Martineau LLP, 17 Hanover Square, London, W1S 1HU on 19 July 2013 at 10:00 a.m.
The circular will soon be available to view on the Company's website (www.summitplc.com) and copies will also be available from the registered office of Summit, 85b Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY.
- END -
dreamcatcher
- 03 Jul 2013 15:19
- 67 of 213
Summit Corporation: N+1 Singer shifts target price from 9p to 8.80p keeping a buy recommendation
dreamcatcher
- 03 Jul 2013 15:23
- 68 of 213
Summit fund-raise attracts the specialist pharma investors
By Ian Lyall July 03 2013, 11:58am Management is also taking part in the cash call, with the biggest contribution coming from non-executive director Jim Mellon, already a significant investor, who is acquiring 20mln shares.Management is also taking part in the cash call, with the biggest contribution coming from non-executive director Jim Mellon, already a significant investor, who is acquiring 20mln shares.
Summit Corp (LON:SUMM) rose 14% in early trade as the group launched a £4.5mln placing at a significant premium to last night’s closing share price.
The company also gave existing private holders of the stock the opportunity to follow their investment with an open offer, which could bring in a further £1mln.
However, it is the institutional support for the issue that will hearten followers of the drug discovery group, which is developing a breakthrough treatment for the muscle wasting disease, Duchenne Muscular Dystrophy (DMD), and a new antibiotic to tackle C.difficile.
“The placing was done at a fairly significant premium to the price,” chief executive Glyn Edwards told Proactive Investors.
“That just shows that while the retail investors are all pretty down about AIM and biotech, the healthcare specialists see our programmes as huge opportunities and really wanted to get a piece of them.”
The demand for stock came from institutions focused on the sector that can see the disconnect between Summit’s valuation (US$26mln) and comparable NASDAQ-listed biopharma companies, such as PTC Therapeutics (worth US$380mln) and Serapta (market cap US$1.2bn).
“The guys who have come are really the main healthcare specialists,” said Edwards.
“What they have seen is our competitor companies on NASDAQ are all valued at a significant premium to us.”
Management is also taking part in the cash call, with the biggest contribution coming from non-executive director Jim Mellon, already a significant investor, who is acquiring 20mln shares.
“Jim is a big investor in the sector and he is excited by this opportunity. He came in on the last placing and then joined the board and he has been really very active,” Edwards said.
Those taking part in the fundraising are being offered stock at 5p, an 18% premium to last night’s closing share price.
The cash injection will be used to fund the development of Summit’s DMD drug.
Having successfully negotiated a phase I trial on healthy volunteers, the group will carry out safety and dose finding clinical study in DMD patients.
The new money will also allow the group to carry out “other activities that will enable a more extensive phase II patient trial to be undertaken”.
Development of Summit’s other lead drug candidate, an antibiotic to tackle C. difficile, is being largely funded by the Wellcome Trust medical charity.
At 11am, the stock was changing hands for 4.86p, for a rise of 0.61p.
“The raise strengthens the group’s financial position, providing it with sufficient cash for at least the next 12 months,” broker N+1 Singer said.
“The group’s development progression remains on track and we remain positive on its future prospects.”
dreamcatcher
- 16 Jul 2013 21:18
- 69 of 213
Summit tops up recent placing
By Philip Whiterow July 16 2013, 10:38am The group is developing treatments for Duchenne Muscular Dystrophy and C. difficile infection.The group is developing treatments for Duchenne Muscular Dystrophy and C. difficile infection.
Drug discovery group Summit (LON:SUMM) has topped up its recent placing with a subscription from existing private shareholders.
The placing was with institutions that largely specialise in healthcare and directors and raised £4.5mln. Other shareholders were also offered shares at 5p through an offer for subscription. Summit said it received acceptances through this offer for 1.52mln shares, raising about a further £76,000.
The group is developing treatments for Duchenne Muscular Dystrophy and C. difficile infection.
dreamcatcher
- 26 Jul 2013 23:04
- 70 of 213
Director Deals - Summit Corporation PLC (SUMM)
Jim Mellon, Non Executive Director, 20,000,000 shares in the company on the 23rd July 2013 at a price of 5.00p. The Director now holds 45,000,001 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com
15:10 26/07/2013
Director Deals - Summit Corporation PLC (SUMM)
Barry Price, Chairman, 500,000 shares in the company on the 23rd July 2013 at a price of 5.00p. The Director now holds 1,514,615 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com
15:10 26/07/2013
Director Deals - Summit Corporation PLC (SUMM)
Dr Frank Armstrong, Non Executive Director, 50,000 shares in the company on the 23rd July 2013 at a price of 5.00p. The Director now holds 50,000 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com
dreamcatcher
- 31 Jul 2013 15:09
- 71 of 213
Summit gets £2.4mln injection
By Jamie Nimmo July 31 2013, 7:35am Summit's drug has the potential to become a life-changing treatment for all sufferers of DMD, which affects around 1,500 boys and young men in the UKSummit's drug has the potential to become a life-changing treatment for all sufferers of DMD, which affects around 1,500 boys and young men in the UK
Summit Corporation (LON:SUMM) has been awarded a £2.4mln grant from the UK Biomedical Catalyst Fund to support the clinical development of its drug for Duchenne Muscular Dystrophy (DMD), the fatal muscle wasting disease.
The Biomedical Catalyst programme, formed in 2011 as part of a government drive, provides funding to British life science companies that show the highest scientific and commercial potential.
Summit’s utrophin modulator drug SMT C1100 is expected to enter patient clinical trials later in 2013 and has the potential to become a life-changing treatment for all DMD sufferers, which affects around 1,500 boys and young men in the UK.
The company is also developing a treatment for the C. difficile infection.
Chief executive Glyn Edwards said: “This award recognises the promise of SMT C1100 as a life-changing drug for boys with this devastating disease.
“We are delighted to receive this prestigious grant from the UK Biomedical Catalyst Fund that will support the clinical development of our DMD programme.”
He added: “This represents a significant endorsement for the concept of utrophin modulation as a treatment approach for all DMD patients.”
The award adds to recent fundraisings including a £4.5mln placing and A$1.25mln from Australian DMD Foundation Save Our Sons (SOS).
dreamcatcher
- 31 Jul 2013 22:32
- 72 of 213
31 Jul N+1 Singer 8.80 Buy
dreamcatcher
- 05 Aug 2013 16:36
- 73 of 213
Up 10% today
skinny
- 05 Aug 2013 16:39
- 74 of 213
I've been watching these - they look to be trying the year high of 5.50p and on reasonable volume.
skyhigh
- 05 Aug 2013 18:45
- 75 of 213
Looking good!
skinny
- 07 Aug 2013 07:04
- 76 of 213
Summit Granted US Patent for Utrophin Modulator SMT C1100 in Treatment of DMD
Oxford, UK, 7 August 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that the United States Patent and Trademark Office has issued patent number 8,501,713 that protects the use of SMT C1100 in treating the fatal muscle wasting disease DMD.
The patent, entitled "Drug Combinations for the Treatment of Duchenne Muscular Dystrophy," covers the combination use of SMT C1100, the small molecule utrophin modulator drug, with corticosteroids such as prednisolone and deflazacort. It provides an exclusivity period until at least February 2029.
Corticosteroids are commonly used in patients to slow the progression of DMD. Summit has shown in the widely used preclinical efficacy model that there is a significant benefit in using prednisolone in combination with SMT C1100. Results from a preclinical fatigue study, analogous to the 6 minute walk distance test used in DMD patient trials, demonstrated that the combined treatment completely protected against fatigue with the treatment group able to travel three and half times the distance of the untreated group. These data have been published in the peer reviewed scientific journal PLoS ONE (Ref: Tinsley et al, Volume 6, Issue 4, May 2011).
"The grant of this US patent covering the use of SMT C1100 in combination with steroids forms part of our broader estate protecting the intellectual property rights of our utrophin modulation programme for DMD," commented Glyn Edwards, Chief Executive Officer of Summit. "This patent estate provides Summit with a commercial advantage from which to exploit the promise of our utrophin modulation programme for the treatment of this devastating disease."
About DMD and Utrophin Modulation
DMD is a progressive muscle wasting disease that affects around 1,500 boys and young men in the UK. It is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of muscles. There is no cure and life expectancy is around the mid-twenties. Utrophin protein is the functional equivalent of dystrophin and non-clinical studies have shown it can substitute for dystrophin to maintain the healthy function of skeletal and cardiac muscle. Utrophin modulation has the potential to slow down or even stop the progression of DMD regardless of the dystrophin mutation. Importantly it is also expected to be complementary to other DMD therapeutic approaches in development.
- END -
skyhigh
- 07 Aug 2013 07:43
- 77 of 213
More good news..looking even better!
dreamcatcher
- 07 Aug 2013 15:07
- 78 of 213
Up 9% :-))
dreamcatcher
- 07 Aug 2013 15:10
- 79 of 213
dreamcatcher
- 08 Aug 2013 17:21
- 81 of 213
skyhigh
- 08 Aug 2013 19:40
- 82 of 213
should start to get alot more positive publicity..this is still another 18+ months from fully achieving it's potential but the momentum is building up nicely! GLA!
skyhigh
- 13 Aug 2013 18:29
- 83 of 213
Consolidating well! a lot more to come but this is an 18/24month burner.. I'm staying in!..(imho)
dreamcatcher
- 14 Aug 2013 16:22
- 84 of 213
Pushing on.
dreamcatcher
- 14 Aug 2013 16:53
- 85 of 213
Closed up 11.11%
skyhigh
- 14 Aug 2013 17:08
- 86 of 213
Nice to see the gradual increase in the SP continuing,,,,I've now doubled my outlay on this from when I went in April last year... I even bought it through the old Hoodless Brennan.. makes a change for an HP rec doesn't ?!... still staying though for time being.
skinny
- 15 Aug 2013 09:24
- 87 of 213
Sold a few of these.
dreamcatcher
- 15 Aug 2013 11:29
- 88 of 213
:-))
skinny
- 15 Aug 2013 11:31
- 89 of 213
Yes - thanks for these - I bought in @5.5.
dreamcatcher
- 15 Aug 2013 11:35
- 90 of 213
I owe you some well dones skinny, so well done on these. :-)) Lets hope they get back to the highs of the past.
dreamcatcher
- 15 Aug 2013 16:47
- 91 of 213
Summit Corporation PLC (SUMM:LSE) set a new 52-week high during today's trading session when it reached 8.13. Over this period, the share price is up 160.00%.
skyhigh
- 15 Aug 2013 18:01
- 92 of 213
:)
dreamcatcher
- 20 Aug 2013 16:36
- 93 of 213
Closed up 10.77%.
Summit Corporation PLC (SUMM:LSE) set a new 52-week high during today's trading session when it reached 9.14. Over this period, the share price is up 204.65%.
dreamcatcher
- 21 Aug 2013 07:04
- 94 of 213
Summit Corporation PLC : Notice of Interim Results
HUG
Summit Corporation plc
('Summit' or 'the Company')
NOTICE OF INTERIM RESULTS
Oxford, UK, 21 August 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, will announce its interim results for the six months ended 31 July 2013 on Thursday, 22 August 2013.
dreamcatcher
- 22 Aug 2013 07:10
- 95 of 213
Summit Corporation PLC : Interim Financial Results
HUG
Summit Corporation plc
("Summit" or "the Company")
INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 JULY 2013
Oxford, UK, 22 August 2013, Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, today reports its interim financial results for the six months ended 31 July 2013.
HIGHLIGHTS
Product Development
Duchenne Muscular Dystrophy ('DMD')
•
Phase 1b patient clinical trial of SMT C1100 on-track to start in H2 2013
•
Activities supporting clinical DMD programme progressing well and include the initiation of novel biomarker programme and drug product manufacture
•
Programme Advisory Board established to support scientific and clinical development of DMD programme
C. difficile Infection ('CDI')
•
Positive results from Phase 1 clinical trial in healthy volunteers showed novel antibiotic SMT 19969 to be safe and well tolerated in this study
•
Encouraging data from Phase 1 trial about future efficacy and specificity of SMT 19969 with results showing it was highly sparing of gut flora bacteria
•
Preparations to commence patient clinical trials in H1 2014 progressing well
Corporate
•
New funding secured from broad range of sources including £4.6 million fund raise with new and existing investors and £2.4 million grant from UK Biomedical Catalyst Fund
•
Dr Frank Armstrong appointed as Non-Executive Chairman with Dr Barry Price taking up a Non-Executive Director role
•
Strengthening of clinical development team including the appointment of Dr David Roblin as Chief Medical Officer
Financial
•
Cash position at 31 July 2013: £6.0 million (31 July 2012: £4.8 million)
•
Operational expenditure in-line with expectations
•
Net loss for the six months ended 31 July 2013 £2.1 million (31 July 2012: £2.2 million)
Glyn Edwards, Chief Executive Officer of Summit commented: "It has been an excellent period for Summit during which our strategy of focusing on the development of our clinical-stage DMD and C. difficile programmes has made substantial scientific progress and also received broad financial support."
"We now look forward to advancing clinical trials into patient populations for both the DMD and CDI programmes to further evaluate these potential life-changing treatments for two serious diseases."
- END
skyhigh
- 22 Aug 2013 08:03
- 96 of 213
Nice! ..nothing new really but a good summary...onwards and upwards! what price in 12/18 months time ?
dreamcatcher
- 22 Aug 2013 08:11
- 97 of 213
Summit entering exciting stage of its development
By John Harrington August 22 2013, 7:49am 'We now look forward to advancing clinical trials into patient populations for both the DMD and CDI programmes to further evaluate these potential life-changing treatments for two serious diseases,' said Glyn Edwards, chief executive officer of Summit."We now look forward to advancing clinical trials into patient populations for both the DMD and CDI programmes to further evaluate these potential life-changing treatments for two serious diseases," said Glyn Edwards, chief executive officer of Summit.
Summit (LON:SUMM), the high-flying drug discovery company, said the first half of its financial year had been an excellent period for the company.
On the product development front, the company’s phase 1b patient clinical trial of SMT C1100, its Duchenne Muscular Dystrophy (DMD) drug, is on track to start before the end of this year, while its novel antibiotic SMT 19969, for the treatment of C. difficile infection, saw positive results from its Phase 1 clinical trial in healthy volunteers, showing it to be safe and well-tolerated.
As is to be expected from a drug discovery and development company that is currently relying chiefly on grant and other not-for-profit funding for its revenue, the company made a loss in the six months to the end of July, but at £2.38mln this was virtually unchanged from the year before, despite spending on research & development rising to £2.08mln from £1.85mln.
Cash at the end of July stood at £6.0mln, up from £4.8mln a year earlier. The company said operational expenditure during the reporting period was in line with expectations.
“The company is entering an exciting stage in its development as our two programmes prepare to commence patient clinical trials. The promise these programmes are showing as life-changing treatments for two serious diseases is being endorsed externally by respected organisations that include the Biomedical Catalyst and the Wellcome Trust,” noted Glyn Edwards, chief executive officer of Summit.
Shares in Summit have doubled over the last month
dreamcatcher
- 22 Aug 2013 10:01
- 98 of 213
Summit Corporation: N+1 Singer shifts target price from 8.80p to 10.70p keeping its buy recommendation
skyhigh
- 22 Aug 2013 21:18
- 99 of 213
Looking good... I'm staying in for the long term..having got in @ 3.5p some while ago it's temting to take the profit but ....
dreamcatcher
- 22 Aug 2013 21:38
- 100 of 213
2007 they were 120p.
dreamcatcher
- 28 Aug 2013 07:11
- 101 of 213
Summit Granted Key Composition of Matter Patent...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT GRANTED KEY COMPOSITION OF MATTER PATENT FOR UTROPHIN MODULATOR SMT C1100 IN THE TREATMENT OF DMD
Oxford, UK, 28 August 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that the United States Patent and Trademark Office has issued a composition of matter patent that protects SMT C1100 and its use in the treatment of the fatal muscle wasting disease DMD.
United States Patent number 8,518,980 is entitled "Treatment of Duchenne Muscular Dystrophy" and will provide a period of exclusivity for the small molecule utrophin modulator SMT C1100 through at least November 2028.
"The grant of this cornerstone patent for SMT C1100 in a key commercial market represents a critical component in our strategy for advancing this promising utrophin modulator in the treatment of DMD," commented Glyn Edwards, Chief Executive Officer of Summit. "Together with the recently issued US patent covering the use of SMT C1100 in combination with steroids, the intellectual property estate protecting this potential life-changing drug has been significantly strengthened as we prepare to start patient clinical trials during the second half of this year."
The patent "Drug Combinations for the Treatment of Duchenne Muscular Dystrophy" was recently issued by the US Patent and Trademark Officer and covers the use of SMT C1100 in combination with steroids such as prednisolone and deflazacort (US Patent number 8,501,713).
About DMD and SMT C1100
DMD is a progressive muscle wasting disease that affects around 1,500 boys and young men in the UK. It is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of muscles. There is no cure and life expectancy is around the mid-twenties. Utrophin protein is the functional equivalent of dystrophin and non-clinical studies have shown it can substitute for dystrophin to maintain the healthy function of skeletal and cardiac muscle. Utrophin modulation has the potential to slow down or even stop the progression of DMD regardless of the dystrophin mutation. Importantly it is also expected to be complementary to other DMD therapeutic approaches in development. SMT C1100, an orally administered small molecule, is Summit's most advanced utrophin modulator and it is expected to start clinical trials in DMD patients during the second half of 2013.
- END -
skyhigh
- 28 Aug 2013 07:23
- 102 of 213
More good patent news released this morning...who knows, in a couple of years time it could be worth 120p again !
Greyhound
- 28 Aug 2013 08:15
- 103 of 213
Excellent news, some positive territory today!
dreamcatcher
- 04 Sep 2013 15:20
- 104 of 213
Summit to Present New Data on C difficile Antib...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT TO PRESENT NEW DATA ON C. DIFFICILE ANTIBIOTIC PROGRAMME AT ICAAC 2013
Oxford, UK, 4 September 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that clinical and preclinical data on its novel, selective antibiotic SMT19969 for the treatment of CDI will be reported in podium and poster presentations at the 53rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy ('ICAAC') meeting in Denver, Colorado, USA from 10-13 September 2013.
Summit has been selected by an expert panel of the American Society for Microbiology to give an oral presentation summarising SMT19969 in the 'Early New Antimicrobial Agents Poster Summary Session', which will highlight the next wave of compounds with potential to move through the clinical development process. This presentation will feature Phase 1 clinical trial and preclinical data which will be included in five posters being reported by Summit and its key collaborators during the conference.
Glyn Edwards, Chief Executive Officer of Summit commented: "Summit is pleased to have been selected to showcase the data on our novel and selective antibiotic SMT19969 for the treatment of C. difficile infection at this major international conference."
Further details about the presentations are below and the full abstracts are available online at www.icaac.org/index.php/online-program-planner.
Tuesday 10 September 2013
Oral Presentation: Early New Antimicrobial Agents Poster Summary Session (2.30-4.30pm MDT)
SMT19969: A Selective Therapy for C. difficile Infection (R Vickers)
Poster Session 018: Clostridium difficile (12.00-2.00pm MDT)
K-167 Effects of a Novel Antimicrobial (SMT19969) for Treatment of Clostridium difficile Infection (CDI) on Gut Flora; EL Best, R Vickers, M Wilcox.
Wednesday 11 September 2013
Poster Session 082: Agents Acting Against Clostridium difficile (11:00am-1:00pm MDT)
F-624 Comparative in vitro Activity of SMT19969, a New Antimicrobial Agent, Against Clostridium difficile and 203 Gram-positive Aerobic and Anaerobic Gut Flora Isolates; EJ Goldstein, DM Citron.
F-625 SMT19969: Effects of Varying MIC Parameters on the in vitro activity against Clostridium difficile; A Wise, D Corbett, P Thommes, S Birchall, R Vickers, PA Warn.
F-626 SMT19969 for Clostridium difficile Infection (CDI): Phase 1 Study Investigating Safety and Pharmacokinetics in Healthy Male Subjects; R Vickers, N Robinson, E Best, M Wilcox, G Tillotson, R Echols.
F-631b Comparative in vitro activity of SMT19969, a new antimicrobial agent against 169 less common intestinal clostridium species: Implications for recurrence; EJC Goldstein, DM Citron.
Copies of these presentations will be available on the Summit website during the ICAAC meeting.
- END -
skinny
- 06 Sep 2013 09:18
- 105 of 213
Trying 10p again.
skyhigh
- 06 Sep 2013 12:26
- 106 of 213
Yep, looking good ...but expecting profit taking this afternoon.. however, I'm staying in for a long while yet!
Topped up on LBB ... looking interesting ahead of results due soon.
dreamcatcher
- 06 Sep 2013 12:30
- 107 of 213
Looks good, although tends to + or - 10%. Good to hold more for the future.
dreamcatcher
- 09 Sep 2013 15:47
- 109 of 213
N+1 Singer needs to update this share. They are slow sometimes. :-))
dreamcatcher
- 09 Sep 2013 15:51
- 110 of 213
Buying at 12p :-))
skinny
- 10 Sep 2013 08:34
- 111 of 213
A 2 bagger for me and still looking up.
skinny
- 11 Sep 2013 07:05
- 112 of 213
dreamcatcher
- 11 Sep 2013 16:04
- 113 of 213
:-))
dreamcatcher
- 11 Sep 2013 16:29
- 114 of 213
Summit presentations points to antibiotic's potential
By Ian Lyall September 11 2013, 7:33am The results from studies of SMT19969 are being presented at a prestigious industry event in Colorado.The results from studies of SMT19969 are being presented at a prestigious industry event in Colorado.
Drug developer Summit (LON:SUMM) is presenting data that points to the huge potential of its antibiotic in tackling the C.difficile superbug.
The results from studies of SMT19969 are being presented at a prestigious industry event in Colorado.
Delegates will be told that the company’s phase-one clinical trial of 56 healthy volunteers revealed the drug to be well tolerated in all doses and sparing on gut flora.
The major bacteria groups were largely unchanged with the exception of total Clostridia, which were reduced during treatment.
Results from preclinical efficacy studies were similarly encouraging.
Evaluating the potency and selectivity of SMT19969, they reveal it is highly targeted, but kills all strains of C.diff tested.
A separate analysis of SMT19969 reveals its use with traditional antibiotics does not diminish its potency.
The data will be revealed in five posters and podium presentation at the 53rd annual Interscience Conference on Antimicrobial Agents and Chemotherapy (IAAC) meeting in Denver.
Summit chief executive Glyn Edwards said: "These new data presented at ICAAC 2013 further validates the promise of SMT19969 as a novel and highly targeted antibiotic for the treatment of this serious infectious disease.
"These results demonstrate that SMT19969 selectively kills all C.difficile strains tested, is highly sparing of healthy gut flora and shows no reduction in activity when used in combination with other antibiotics. This profile is encouraging for treating CDI and significantly reducing rates of recurrent disease and we look forward to advancing SMT19969 into phase-two clinical trials in the second half of 2014."
dreamcatcher
- 11 Sep 2013 16:31
- 115 of 213
Come on N+1 Singer upgrades needed fast.
dreamcatcher
- 11 Sep 2013 16:31
- 116 of 213
Come on N+1 Singer upgrades needed fast.
skinny
- 12 Sep 2013 15:53
- 117 of 213
Just taken some more off of the table here @13.61
dreamcatcher
- 12 Sep 2013 16:57
- 118 of 213
Closed up 17.71%
3 monkies
- 12 Sep 2013 16:58
- 119 of 213
You lucky guys - I never joined unfortunately although I have looked at them for years. Well done.
dreamcatcher
- 12 Sep 2013 18:01
- 120 of 213
:-))
dreamcatcher
- 16 Sep 2013 16:11
- 121 of 213
Another good day.
3 monkies
- 16 Sep 2013 16:20
- 122 of 213
Doing well and I did not join, should have got in weeks ago but hey ho. Well done to all that did.
dreamcatcher
- 18 Sep 2013 16:25
- 123 of 213
Profit taking today, with the usual 10% fall after a good rise.
Dynamite
- 19 Sep 2013 15:37
- 124 of 213
dreamcatcher
- 19 Sep 2013 15:48
- 126 of 213
Posted a week ago on ll - The last target set by this guy was broken for this reason. Charts don't work with news driven stock.
The reality is that Summit's peers in the USA are valued at what would equate to 85p or higher for Summit, this is the reason for the rise, particularly as Summit is now presenting it's finding to a US audience who tend to appreciate the work of BioTechs unlike in the UK.
I expect this stock to keep rising, and if anyone of it's lead drugs makes it to the market place, then it will be £2 per share, not 85-100p and certainly way above some chartists 20p! 12p made me laugh, so does 20p!
IMHO, DYOR etc
dreamcatcher
- 20 Sep 2013 16:51
- 127 of 213
dreamcatcher
- 20 Sep 2013 16:57
- 128 of 213
Sad for the families, may prove very good for Summit investors. Still a way to go yet.
skinny
- 23 Sep 2013 11:41
- 129 of 213
dreamcatcher
- 23 Sep 2013 19:44
- 130 of 213
A lot of excitement across the boards today about this share.
dreamcatcher
- 24 Sep 2013 16:18
- 131 of 213
No stopping this one.
dreamcatcher
- 24 Sep 2013 16:54
- 132 of 213
Summit Corporation PLC (SUMM:LSE) set a new 52-week high during today's trading session when it reached 19.18. Over this period, the share price is up 424.14%.
skyhigh
- 24 Sep 2013 16:54
- 133 of 213
Yep, indeed!...going skyhigh....just like PLE....then hopefully LBB, MDZ, PIRI, COMS, CEE, QPP amongst others (already done well with REM having bought b4 the surge and have taken profits since)
skyhigh
- 24 Sep 2013 16:55
- 134 of 213
sorry, that's CCE, not CEE!
dreamcatcher
- 24 Sep 2013 22:02
- 135 of 213
22 Aug N+1 Singer 10.70 Buy - Looking dated now the sp is at 19p . As Delia Smith would say to N+1 Singer '' Lets be aving yer''. lol
skinny
- 26 Sep 2013 07:21
- 136 of 213
APPOINTMENT OF NOMINATED ADVISER
Oxford, UK, 26 September 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, is pleased to announce the appointment with immediate effect of Cairn Financial Advisers as the Company's Nominated Adviser (Nomad).
- END -
dreamcatcher
- 30 Sep 2013 15:52
- 137 of 213
Summit to present at California medical congress
By John Harrington September 30 2013, 2:05pm Summit is an Oxford based drug discovery and development company targeting high-value areas of unmet medical need including DMD and C. difficile infection.Summit is an Oxford based drug discovery and development company targeting high-value areas of unmet medical need including DMD and C. difficile infection.
Summit (LON:SUMM) is to give a presentation on one of its lead drugs at the 18th International World Muscle Society congress in California.
The poster presentation, entitled "Future clinical and biomarker development for SMT C1100, the first utrophin modulator to enter clinical trials for Duchenne Muscular Dystrophy", will outline the proposed clinical development plan to achieve proof of concept for SMT C1100 in Duchenne muscular dystrophy (DMD) patients.
Summit's C1100 development drug has the potential to maintain healthy muscle tone. This offers a potential breakthrough in treating DMD, a rare wasting disease that affects boys only (and 1,500 here in the UK).
Details will also be presented on the supporting biomarker programme that aims to develop new exploratory clinical endpoints to help evaluate the benefit of therapies such as SMT C1100 in future DMD patient trials.
The Congress is taking place from 1 October to 5 October.
A copy
skinny
- 30 Sep 2013 21:03
- 138 of 213
dreamcatcher
- 02 Oct 2013 20:50
- 139 of 213
halifax
- 03 Oct 2013 12:42
- 140 of 213
sp down 10% @13p profit taking?
dreamcatcher
- 17 Oct 2013 16:39
- 141 of 213
A good 8% pull back today.
dreamcatcher
- 18 Oct 2013 14:03
- 142 of 213
And another 10%
dreamcatcher
- 01 Nov 2013 07:09
- 143 of 213
Summit Receives Regulatory Approval to Start Ph...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT RECEIVES REGULATORY APPROVAL TO START PHASE 1B CLINICAL TRIAL OF SMT C1100 IN DMD PATIENTS
Oxford, UK, 1 November 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that its Phase 1b Clinical Trial Application for SMT C1100 has received approval from the UK Medicines and Healthcare products Regulatory Agency ('MHRA') and the Ethics Review Committee. SMT C1100 is a small molecule utrophin modulator that has the potential to treat all patients with DMD, regardless of the underlying genetic fault.
"Securing regulatory approval for the first in patient Phase 1b clinical trial has achieved another important milestone in the development of utrophin modulator, SMT C1100, for DMD," commented Glyn Edwards, Chief Executive Officer. "We believe that utrophin modulation is a novel disease-modifying approach for all boys with DMD and this Phase 1b trial forms an integral part of our wider clinical plans towards establishing SMT C1100 as a viable treatment for this devastating condition."
The Phase 1b trial will be a dose-escalating, open-label study and will be conducted in a total of 12 paediatric patients with DMD, aged between 5 and 11 years. It will evaluate the safety and tolerability of SMT C1100, and will measure blood concentration levels of the drug as Summit aims to confirm the dose to be used in a subsequent patient proof of concept efficacy trial. The Phase 1b trial will be conducted at up to four NHS hospitals located in the UK and patient recruitment is expected to start shortly.
The Chief Investigator for the trial, Professor Francesco Muntoni, Paediatric Neurologist at Great Ormond Street Hospital and Director of the Dubowitz Neuromuscular Centreadded, "Utrophin is a promising approach for the treatment of all DMD patients, regardless of their genetic mutation. It also has the potential to be complementary to other therapeutics approaches in clinical development and the start of the first patient trial of SMT C1100 is an important moment for the whole DMD community."
Further details about the clinical trial will be made available via www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
- END -
skinny
- 01 Nov 2013 07:18
- 144 of 213
Sounds promising!
dreamcatcher
- 01 Nov 2013 16:14
- 145 of 213
1 Nov N+1 Singer 11.00 Buy
dreamcatcher
- 01 Nov 2013 20:13
- 146 of 213
Shares in drug developer Summit Corporation (LON:SUMM) may not have got the shot in the arm it was hoping for, but twice the normal number of shares traded changed hands on the day.
Summit received UK regulatory approval to start patient trials of its SMT C1100 drug.
SMT C1100 is being developed for use in the treatment of the fatal muscle wasting disease Duchenne Muscular Dystrophy (DMD). It has the potential to treat all patients with DMD, regardless of the underlying genetic fault.
The Phase 1b trial will be a dose-escalating, open-label study and will be conducted in a total of 12 paediatric patients with DMD, aged between 5 and 11 years.
The study will evaluate the safety and tolerability of SMT C1100, and will measure blood concentration levels of the drug as Summit aims to confirm the dose to be used in a subsequent patient proof of concept efficacy trial.
http://www.proactiveinvestors.co.uk/companies/market_reports/62824/proactive-news-summary-falcon-oil-gas-summit-corporation-metminco-fastjet-rurelec-0000.html
dreamcatcher
- 05 Nov 2013 07:04
- 147 of 213
Summit and Joining Jack Enter Funding Agreement...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT AND JOINING JACK ENTER FUNDING AGREEMENT TO SUPPORT DEVELOPMENT OF NOVEL BIOMARKERS FOR DMD
Oxford, UK, 5 November 2013 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, is pleased to announce it has entered into a funding agreement with the UK charity, Joining Jack, to support the development of novel biomarkers for DMD.
Summit aims to develop new biomarkers that are both related to the mechanism of its utrophin modulator candidate SMT C1100 and to other aspects of muscle health, including muscle fibre regeneration and inflammation. The information gained from this effort will support the clinical development of SMT C1100 and other therapeutic candidates for the treatment of DMD. Joining Jack were formed in 2012 to support research into identifying therapies for DMD and they will provide up to £100,000 in funding to support this development effort.
"Summit is delighted to enter this agreement with Joining Jack to support our development programme to create novel and meaningful biomarkers to help determine the impact of new candidates like SMT C1100 in clinical trials and to supplement the existing endpoints, which are often seen as limited and challenging," commented Glyn Edwards, Chief Executive Officer of Summit. "We are grateful for the continuing support of the DMD community in advancing this therapeutic approach which could potentially treat all patients with DMD, regardless of the underlying genetic cause."
Andrew Johnson from Joining Jack added: "Our mission is to provide support for potential new therapies in DMD to ultimately ensure that we can make a difference for this generation of boys suffering from this disease. We believe that SMT C1100 and the utrophin modulation approach holds significant promise."
The biomarker development work will be conducted in collaboration with the leading research groups of Dr Jenny Morgan, Professor Caroline Sewry and Professor Francesco Muntoni at the Institute of Child Health, University College London.
- END -
skinny
- 18 Nov 2013 07:45
- 148 of 213
N+1 Singer Buy 10.13 10.13 11.00 16.30 Reiterates
skinny
- 25 Nov 2013 07:07
- 149 of 213
Summit and the University of Oxford Enter Strategic Alliance to Develop Treatments for DMD
SUMMIT AND THE UNIVERSITY OF OXFORD ENTER STRATEGIC ALLIANCE TO DEVELOP TREATMENTS FOR DUCHENNE MUSCULAR DYSTROPHY
Summit acquires exclusive rights to a pipeline of novel utrophin modulators and core technology, and an exclusive option to intellectual property arising from the research collaboration
Technology acquired through issue of up to 42.5 million new ordinary shares
kayha
- 25 Nov 2013 10:42
- 150 of 213
WATCH: Summit Corporation CEO Glyn Edwards and Prof Kay Davies talk about a strategic alliance in Duchenne Muscular Dystrophy
Click here to watch
dreamcatcher
- 25 Nov 2013 18:11
- 151 of 213
UPDATE - Summit seals exclusive deal with Oxford University that underpins its DMD programme
By Ian Lyall November 25 2013, 4:27pm The all-paper deal with Oxford University will see it issue it issue 42.5mln shares, worth just over £3.9mln as of Friday’s close.The all-paper deal with Oxford University will see it issue it issue 42.5mln shares, worth just over £3.9mln as of Friday’s close.
---ADDS FURTHER CEO COMMENTS AND SHARE PRICE---
Shares in drug developer Summit (LON:SUMM) advanced around 10% on Monday after unveiling a deal to acquire a pipeline of new utrophin modulators, the technology at the core of its treatment for Duchenne Muscular Dystrophy (DMD).
The all-paper deal with Oxford University will see it issue 42.5mln shares, worth just over £3.9mln as of Friday’s close.
These assets have been developed at the university by research teams led by Professor Kay Davies, an internationally acclaimed expert in DMD; Professor Stephen Davies, the Waynflete Professor of Chemistry; and Dr Angela Russell, an expert in medicinal chemistry and pharmacology.
As part of the collaboration, Summit will sponsor a drug discovery programme to identify and develop additional utrophin modulator drugs.
Davies, a co-founder and former director of Summit, is re-joining the board a non-executive director following the deal.
Chief executive Glyn Edwards said: “The alliance provides access to differentiated classes of utrophin modulators, potentially with new mechanisms, to complement our clinical candidate SMT C1100, while also establishing a strong drug pipeline for the future.
“Importantly, it will help to cement our long-term relationship with the scientific leaders in the field at the University of Oxford."
DMD is a rare but fatal muscle wasting disease that occurs in boys.
Utrophin is at the heart of Summit’s drug candidate C1100 and it is thought to act in a similar way to dystrophin, which regulates muscle tone and function.
Edwards, in a video presentation, said it was important to bring through the next generation of compounds - and the tie-up with Oxford would do this.
"For while C1100 is the pathfinder, and we believe will revolutionise the treatment of Duchenne Muscular Dystrophy, we can already see ways of improving on that," he told investors.
"It is quite common when there are medical breakthroughs to have a first-in-class compound that gets to market first and moves the treatment forward hugely.
"But we can already see ways of improving on C1100 by working with the thought leaders at the University of Oxford."
The reaction to the tie-up was a positive one with the shares rising 10% to 10.12p a share, valuing the business at £46mln
skinny
- 09 Dec 2013 07:14
- 153 of 213
skinny
- 12 Dec 2013 12:18
- 154 of 213
parrisf
- 10 Jan 2014 12:39
- 155 of 213
Has anyone any news about Summit?
dreamcatcher
- 11 Jan 2014 09:19
- 156 of 213
:-))
skinny
- 14 Jan 2014 14:37
- 157 of 213
On the up again +11%.
skinny
- 15 Jan 2014 10:24
- 158 of 213
Up another 9%.
dreamcatcher
- 16 Jan 2014 16:47
- 159 of 213
Sarepta DMD trial results buoy Summit
By Jamie Nimmo
January 16 2014, 4:37pm
Sarepta and Summit are both working towards a treatment for DMD, a rare but fatal muscle-wasting disease
The latest trial results from America’s Sarepta Therapeutics bode well for AIM-listed Summit (LON:SUMM).
That’s because the pair are both working towards a treatment for Duchenne Muscular Dystrophy (DMD), a fatal muscle-wasting disease that affects boys.
Sarepta revealed at the JPMorgan Healthcare Conference in San Francisco that Eteplirsen trial patients showed continued stability when walking as part of the ongoing Phase IIb study.
Sufferers on the drug were able to walk further than the group of patients given the placebo, confirming the benefits of the drug.
Summit may look like a minnow alongside Sarepta and its $1 billion market capitalisation. But that’s only after a two-year surge that has seen Sarepta’s share price jump from 60 cents to $26.90 – it jumped another 35% today.
Summit, which rose 8% to 12.7p on the back of the news, treated its first patient suffering from DMD last month as part of a phase Ib clinical trial of its own treatment, SMT C1100.
Richard Pye, head of corporate development and communications at Summit, explained that Eteplirsen will only treat 13% of DMD boys since it is specific to a genetic form.
Summit’s treatment meanwhile would treat all sufferers.
Pye says that because of the difference in approach between the two companies, he sees Sarepta less as a rival and more as “complimentary”.
“There is progress being made and there is a better understanding from a clinical trial perspective as to what’s going on and what effect they are seeing in patients. That helps us when we get to do our clinical studies as well,” he said.
“Having an approach that enables us to target all the boys irrespective of the genetic mutation they’ve got puts us in a really strong position.”
Summit’s trial involves twelve boys aged between five and eleven years and is taking place at up to four NHS hospitals in the UK.
galatica
- 07 Feb 2014 12:31
- 160 of 213
this stock has been on the rocks for some time, jam tomorrow? maybe one day
parrisf
- 12 Feb 2014 08:58
- 161 of 213
Why this sudden drop?
halifax
- 12 Feb 2014 09:54
- 162 of 213
yesterdays news 323m new shares to be issued @6.5p
parrisf
- 12 Feb 2014 10:16
- 163 of 213
Oh. Not good news short time. Thanks Hal.
dreamcatcher
- 12 Feb 2014 17:35
- 164 of 213
Summit funded to do 'comprehensive job' on two drug programmes
By Jeremy Naylor
February 12 2014, 2:39pm
Glyn Edwards, chief executive of Summit (LON:SUMM), tells Proactiveinvestors it is now 'really well funded' on two exciting drug programmes. He also reveals the group has attracted new shareholders from the US, a hotbed for biotech investment.
http://www.proactiveinvestors.co.uk/companies/stocktube/2537/summit-funded-to-do-comprehensive-job-on-two-drug-programmes--2537.html
skinny
- 26 Feb 2014 07:17
- 165 of 213
RESULT OF OFFER FOR SUBSCRIPTION TO QUALIFYING SHAREHOLDERS
Oxford, UK, 26 February 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, announced on 11 February 2014 it had conditionally raised £21.0 million (before expenses) through the placing of 323,076,924 new Ordinary shares at 6.5 pence per share. In addition, the Company provided Qualifying Shareholders with the opportunity to subscribe for new Ordinary shares on the same terms. This Offer for Subscription was not underwritten.
The Offer for Subscription has now closed and, in accordance with its terms, the Company has received valid acceptances in respect of 111,265,720 Ordinary Shares from Qualifying Shareholders. The Offer for Subscription was more than seven times over-subscribed. The directors of the company have undertaken a scaling back process. The Company has raised gross proceeds of £1.0 million from the Offer for Subscription making a total of £22.0 million ($36.0 million) from the Placing and Offer for Subscription.
Shareholder authority is required to allot the new Ordinary Shares and therefore the Placing and the Offer for Subscription are conditional on the passing of the resolutions that have been proposed at a General Meeting of shareholders to be held at 10:00am on 28 February 2014, at the officers of Fasken Martineau, 17 Hanover Square, London, W1S 1HU.
- END -
skinny
- 04 Mar 2014 07:04
- 166 of 213
CHANGE OF BROKER
Oxford, UK, 4 March 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, announces that Hybridan has resigned as broker to the Company. N+1 Singer has been appointed sole broker to the Company. Both these changes take place with immediate effect.
- END -
dreamcatcher
- 11 Mar 2014 13:40
- 167 of 213
Summit primed for positive momentum - N+1 Singer
By Giles Gwinnett
March 11 2014, 1:08pm
Meanwhile, SMT 19969 for C.dif will begin a Phase II proof of concept clinical trial during the first half of 2014
Summit Corporation (LON:SUMM) is at an interesting stage with phase II patient clinical trials on the horizon, highlighted broker N+Singer on Tuesday.
And its recent £22mln fundraise provides the necessary funds to progress its two development programmes - for Duchenne Muscular Dystrophy (DMD) and C.difficile.
The firm's lead candidate is SMT C1100 for the treatment of DMD, is the most advanced utrophin modulator in Summit’s modulator portfolio, noted the broker.
It is currently in Phase Ib with top line results expected in the second quarter of 2014, said analyst Sheena Berry.
"Phase II is scheduled to begin in Q3. The group also aims to identify a next generation utrophin modulator this year for clinical progression."
Meanwhile, SMT 19969 for C.dif will begin a Phase II proof of concept clinical trial during the first half of 2014.
Berry notes that most of its fair valuation on the group is generated from the DMD opportunity, which is the programme which provides Summit with the greatest opportunity, reckons the broker.
"As the programmes progress through development and additional next generation modulators introduced, our intrinsic value of 11p per share will clearly increase," said the analyst.
With the additional funding the group is in a strong position to maintain its positive momentum and capitalise on game changing opportunities. In our view, Summit is a high quality business in a strong position to penetrate its target markets.
Shares are currently unchanged at 8.625p.
panto
- 11 Mar 2014 14:16
- 168 of 213
The offer for SUBSCRIPTION for share holders was 48.7M and the valid acceptances were 111.6M that is 2.2 times over oversubscribed, yet the company says 7 times ( below )
but ..............
Qualifying Shareholders will also be given an opportunity to participate in an Offer for Subscription of up to 15,384,616 new Ordinary Shares of Summit at 6.5 pence per new Ordinary Share to raise up to £1.0 million, in addition to the funds raised from the Placing.
The company did not say how many shares the shareholders are receiving on any RNS, and my broker could not explain either, I made a phone call to the company and are saying the Offer for Subscription was more than seven times over-subscribed so shareholders will get 8.50% of their shareholding - not for shares applying for -
The Offer for Subscription has now closed and, in accordance with its terms, the Company has received valid acceptances in respect of 111,265,720 Ordinary Shares from Qualifying Shareholders. The Offer for Subscription was more than seven times over-subscribed.
more to come I wonder, shareholders allways lose to large investors than most times will sell soon for a large profit.
skinny
- 18 Mar 2014 07:05
- 169 of 213
Summit Receive FDA Clearance of IND Application for Phase 2 Study of SMT19969 to Treat CDI
SUMMIT ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR PHASE 2 STUDY OF SMT19969 TO TREAT C. DIFFICILE INFECTION
Initiation of the Phase 2 trial expected during H1 2014
£1.9m milestone payment from Wellcome Trust received
Oxford, UK, 18 March 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces clearance by the US Food and Drug Administration ('FDA') of its Investigational New Drug application ('IND') to initiate a Phase 2 proof of concept study of the novel antibiotic SMT19969 for the treatment of CDI. The submission of this application has resulted in a £1.9m milestone payment to Summit by the Wellcome Trust, proceeds of which will support the study. This payment is part of a £4.0m Translational Award from the Wellcome Trust for the development of SMT19969.
"SMT19969 has demonstrated high selectivity for only clostridia in a Phase 1 study of healthy volunteers," commented Glyn Edwards, Chief Executive Officer of Summit. "If this profile is replicated in future studies, SMT19969 could potentially offer a differentiated and more beneficial option to current CDI treatments, which continue to undermine the natural balance of the gut flora and lead to recurrent disease. We are excited about initiating a Phase 2 proof of concept clinical trial with the continued support of the Wellcome Trust."
The Phase 2 study, named CoDIFy, will be a double blind, active controlled trial comparing the efficacy of SMT19969 to vancomycin (the current standard of care) in CDI patients through assessment of both initial cure rates and absence of recurrent CDI within 30 days of the end of treatment. The Phase 2 trial will recruit 100 patients with CDI and enrolment is expected to commence during H1 2014 at sites in the US and Canada.
SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with exceptionally high levels of antibacterial selectivity. This targeted antibiotic has displayed efficacy in two key disease models while showing complete protection from recurrent disease. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be safe and well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported which demonstrated that SMT19969 was highly sparing of gut flora.
- END -
panto
- 20 Mar 2014 13:55
- 170 of 213
Some large volume for the last couple days as the share price is moving higher

panto
- 21 Mar 2014 12:24
- 171 of 213
up to 10.25p today, the volume has played a good part on the rise
Summit on BBC Breakfast 14 March 2014...
panto
- 24 Mar 2014 10:48
- 172 of 213
Some good early morning buys and the shares spiked, it has now settled
skinny
- 21 May 2014 07:08
- 173 of 213
Summit Report Preliminary Results from Phase 1b Clinical Trial of SMT C1100 for DMD
SUMMIT REPORTS PRELIMINARY RESULTS FROM PHASE 1B CLINICAL TRIAL OF SMT C1100 FOR DUCHENNE MUSCULAR DYSTROPHY
Safe and well tolerated at all doses tested in the study
Reduction in CK levels, an enzyme associated with muscle damage
Next patient clinical trial expected to start in Q4 2014
Oxford, UK, 21 May 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that SMT C1100 for the treatment of DMD has successfully met its primary endpoint of safety and tolerability in a Phase 1b clinical trial in patients with the disease. SMT C1100 is an oral small molecule utrophin modulator that has the potential to treat all patients with DMD, regardless of the underlying dystrophin fault causing the disease.
The Phase 1b dose-escalating trial was conducted in 12 patients with DMD aged between 5 and 11 years old. These preliminary results show that SMT C1100 was safe and well tolerated at all doses tested in the study, and that there were no issues with patient compliance. All the boys had variable blood plasma concentrations of SMT C1100 with only two of the boys achieving concentrations similar to those of the adult volunteers in the 2012 Phase 1 study. Initial evidence suggests that the variability in drug uptake may be due to differences in diet and to other disease-related factors.
The non-placebo controlled trial also measured creatine kinase ('CK') levels, an enzyme that is associated with muscle fibre damage and elevated in boys with DMD. In the majority of patients there was a reduction in CK levels during dosing with SMT C1100. These data are consistent with non-clinical in vivo efficacy studies in the mdx model of DMD that showed SMT C1100 reduced CK levels after only 15 days.
"This first-ever trial of a utrophin modulator in DMD patients demonstrated the excellent safety profile of SMT C1100 with the study successfully achieving its primary endpoint," commented Glyn Edwards, Chief Executive Officer of Summit. "In addition, the positive impact on the enzyme markers of muscle health was both unexpected and exciting with these data potentially representing SMT C1100's first signs of activity in DMD patients."
These preliminary trial data will be reviewed further by Summit and is expected to lead to a revision of future clinical trial plans in order to determine the optimal way, either through dietary means or drug formulation changes, to address the drug uptake differences between DMD patients and healthy volunteers. The next patient study is now expected to start in Q4 2014.
Glyn Edwards continued, "Our goal with utrophin modulation is to treat all patients with DMD. Armed with a greater understanding of the importance of diet and other disease related factors, our future clinical trial plans will be modified and will increase the potential likelihood of achieving this goal."
Webcast Presentation
A webcast presentation by Glyn Edwards on the preliminary Phase 1b results is available by clicking on the following link: http://www.brrmedia.co.uk/event/123676?popup=true
About the Phase 1b Clinical Trial
The Phase 1b trial was a dose-escalating, open-label study conducted in paediatric patients with DMD to evaluate safety, tolerability and drug exposure. The trial enrolled 12 patients aged between 5 and 11 years, divided equally into three dose cohorts. Each cohort received daily oral doses of SMT C1100 for a total of ten days with a dose escalating safety review taking place after each cohort had completed dosing. The trial was conducted at four NHS hospitals in the UK with the Chief Investigator being Professor Francesco Muntoni at Great Ormond Street Hospital, London. Further information about the trial is available at www.clintrial.gov.
- END -
js8106455
- 23 May 2014 18:29
- 174 of 213
LISTEN:
Summit Corporation - Phase 1b clinical trial in DMD patients
Click here to listne
skinny
- 03 Jun 2014 07:14
- 175 of 213
Notice of AGM and Proposed Capital Reorganisation
NOTICE OF ANNUAL GENERAL MEETING
AND PROPOSED CAPTIAL REORGANISATION
Oxford, UK, 3 June 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection, announces that its Annual Report and Accounts for the year ended 31 January 2014 together with the Notice of Annual General Meeting (the 'Notice') have been posted to shareholders. Copies of both documents are available on the Company's website, www.summitplc.com.
Also to be considered by shareholders at the meeting and detailed in the Notice are proposals for a capital reorganisation that will simplify the share capital structure of the Company (the 'Capital Reorganisation'). The proposals are subject, inter alia, to shareholder approval and, following their implementation, will result in the Company having a single class of Ordinary Shares in issue.
The Capital Reorganisation will consist of three elements:
a Consolidation of every 20 Existing Ordinary Shares into one Consolidated Ordinary Share;
an immediate Sub-Division of each of those Consolidated Ordinary Shares into one New Ordinary Share and 19 New Deferred Shares; and
a Capital Reduction to cancel the Existing and New Deferred Shares and a reduction in the Company's Share Premium Account.
Full details of the Capital Reorganisation are included in the Notice along with an explanation why the Directors consider this activity to be in the best interests of the Company and its shareholders.
The Annual General Meeting will be held at 10:00am on Thursday, 3 July 2014 at the Milton Park Innovation Centre, 99 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK.
more...
skinny
- 17 Jun 2014 07:08
- 176 of 213
Summit Establishes US Office and Strengthens its Drug Development Team
SUMMIT ESTABLISHES US OFFICE IN CAMBRIDGE, MASSACHUSETTS AND STRENGTHENS ITS DRUG DEVELOPMENT OPERATIONS TEAM
Oxford, UK, 17 June 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), announces it has established US operations in Cambridge, Massachusetts and strengthened its drug development operations team following the recruitment of new clinical and preclinical employees. The US operations are being formed to facilitate greater interactions with academic, clinical and business leaders in Summit's areas of therapeutic development.
Located at the new US office will be key members of the clinical development team: Dr Michael Boss, the overall leader of the utrophin modulation programme for DMD, and Dr Bindu Tejura who recently joined Summit as Vice President of Clinical Development and will be involved in both the DMD and CDI programmes.
"Summit's expansion to the US supports our strategy to continue to strengthen the investor base and allows for greater access to academic and industry key opinion leaders in North America, in order to advance our clinical programmes that will have a significant proportion of their development undertaken there," commented Glyn Edwards, Chief Executive Officer of Summit. "With our DMD and CDI programmes reaching key inflection points, it is important that we continue to strengthen the team supporting their development."
The operations and undertaking in the US will be conducted through a wholly owned subsidiary company, Summit Therapeutics Inc., which is incorporated in Delaware.
About Dr Michael Boss
Dr Michael Boss is a senior executive with broad operating experience in the biotechnology industry that includes biomedical product development, business development, identification and licensing of new technologies, intellectual property and project management. During his career, Dr Boss has held a number of positions including Chief Operating Officer and Chief Business Officer at the cancer and autoimmune biotechnology company Xanthus Pharmaceuticals Inc. At Xanthus he led a number of activities including the successful sale of the company to Antisoma, after which he continued to lead the autoimmune business. Dr Boss has experience of DMD and disease biomarkers from his time as Vice President of R&D and Vice President of Operations at Athena Diagnostics Inc. which developed the first test for DMD, along with the development of tests for many genetic and neurological diseases. Earlier in his career at Celltech Ltd he was the lead investigator on a landmark patent that enabled for the first time the genetic engineering and manufacture of recombinant monoclonal antibodies. Dr Boss holds a PhD in immunology (University of London), an MBA (London Business School) and he completed his postdoctoral fellowship with the Nobel Laureate Dr David Baltimore (Massachusetts Institute of Technology).
About Dr Bindu Tejura
Dr Bindu Tejura is a Medical Director and Clinical Research Investigator with over 10 years of experience in the development of new drugs and has an excellent understanding of drug development. She has been responsible for the design and interpretation of many Phase 1 and 2 clinical trials as well as several large Phase 3 studies. Prior to joining Summit, Dr Tejura was Medical Director at Millennium Pharmaceuticals Inc. where she gained broad clinical experience including being lead clinician on a large Phase 3 oncology study. She has held a number of previous roles at Cubist Pharmaceuticals, Dyax Inc. and Antisoma plc. Dr Tejura is a qualified clinician having undertaken her medical training at a number of hospitals and medical centres in the UK and the US. She holds a Bachelor of Medicine degree as well as a Bachelor of Pharmacology degree from the University of Wales, College of Medicine (Cardiff).
- END -
skinny
- 23 Jun 2014 07:19
- 177 of 213
dreamcatcher
- 03 Jul 2014 07:25
- 178 of 213
Summit Announces First Patients Dosed in a Phas...
HUG
Summit Corporation plc
('Summit' or the 'Company')
SUMMIT ANNOUNCES FIRST PATIENTS DOSED IN A PHASE 2 CLINICAL TRIAL OF THE NOVEL ANTIBIOTIC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 3 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that the first patients have been dosed in its Phase 2 proof of concept clinical trial that is evaluating the novel oral antibiotic SMT19969 for the treatment of CDI.
"SMT19969 is a new and differentiated antibiotic that combines excellent potency with unprecedented selectivity for C. difficile meaning it has a minimal antibiotic effect against bacteria that comprise the healthy gut flora. This profile is expected to be important in treating initial infection and reducing the high rates of disease recurrence, the major clinical issue that effects up to 30% of patients," commented Glyn Edwards, Chief Executive Officer of Summit. "The enrolment and dosing of the first patients in this Phase 2 trial achieves another important development milestone on the path towards establishing proof of concept for this highly promising treatment."
About the Phase 2 Clinical Trial
The Phase 2 trial, named CoDIFy, is a randomised, double-blind, active comparator study that will evaluate the efficacy of SMT19969 relative to vancomycin, the current standard of care in the treatment of CDI following ten days of dosing. The primary endpoint of the trial will measure the sustained clinical response, which is defined as cure from the initial infection with no recurrence within 30 days post end of treatment. The safety and tolerability of SMT19969 will also be evaluated. The study will recruit approximately 100 patients randomised into two equally sized treatment arms receiving SMT19969 and vancomycin respectively.
The study is being performed in North America and will involve approximately 25 trial sites in the US. Summit has now received clearance from Health Canada regarding its Clinical Trial Application which adds up to five additional study sites in Canada. Top line data from this trial is expected to be reported in the first half of 2015. Further information about this study is available on www.clinicaltrials.gov.
The development of SMT19969 is being supported by a Translational Award from the Wellcome Trust.
About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness caused by infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that disrupt the normal gastrointestinal (gut) flora and so allow C. difficile to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with high rates of recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.
Recent years have seen a significant increase in CDI and it is estimated that there are approximately 900,000 cases across Europe and North America per annum. This rise means CDI has a high economic burden with the annual cost of care in the US alone estimated at over $4.8 billion.
- END -
dreamcatcher
- 04 Jul 2014 20:38
- 179 of 213
consolidation of the shares @20/1
dreamcatcher
- 07 Jul 2014 16:23
- 180 of 213
Summit to unveil promising new results for its DMD treatment
By John Harrington
July 07 2014, 7:59am
A poster presentation reporting these additional findings from the Phase 1b clinical trial will be presented at ICNMD at 11:30am CET on Monday 7 July 2014.
A poster presentation reporting these additional findings from the Phase 1b clinical trial will be presented at ICNMD at 11:30am CET on Monday 7 July 2014.
Summit (LON:SUMM) is to present promising new data from its recently completed Phase 1b clinical trial of SMT C1100, its treatment for Duchenne Muscular Dystrophy (DMD).
The company will unveil the data at the 13th International Congress on Neuromuscular Diseases (ICNMD) being held between 5-10 July in Nice, France.
The results of this study showed a statistically significant decrease in key enzymes associated with muscle damage and support the proposed mechanism of action of SMT C1100.
DMD is a rare but fatal muscle wasting disease that occurs in boys.
The latest study results cover the impact of dosing with SMT C1100 on blood levels of the enzymes creatine kinase (CK), aspartate aminotransferase (AST) and alanine aminotransferase ('ALT').
In healthy people, the levels of these enzymes are normally very low but in patients with DMD, muscle cells are weakened by the lack of dystrophin, causing these enzymes to leak out and accumulate in the blood.
During dosing with SMT C1100, a statistically significant reduction in CK, AST and ALT levels was observed when compared to pre-dose baseline levels. Blood levels of these enzymes increased towards pre-dosing levels after dosing stopped.
Summit said the results are consistent with the proposed mechanism of action of the utrophin modulator SMT C1100, whereby its effect would result in lower muscle damage and lead to lower levels of these key markers in the blood. The data from this Phase 1 study are encouraging and clearly support further evaluation in a placebo-controlled study.
skinny
- 09 Jul 2014 07:19
- 181 of 213
FDA Grants QIDP Designation to Summit's Novel Antibiotic for the Treatment of C. difficile Infection
FDA GRANTS QIDP DESIGNATION TO SUMMIT'S NOVEL ANTIBIOTC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 9 July 2014 - Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), announces that the US Food and Drug Administration ('FDA') has designated the Company's novel antibiotic SMT19969 for the treatment of CDI as a Qualified Infectious Disease Product ('QIDP').
The QIDP designation allows Summit to benefit from a number of incentives supporting the development of new antibiotics including eligibility for Priority Review and Fast Track status and, if SMT19969 receives marketing approval from the FDA, a five-year extension of market exclusivity. The QIDP incentives are provided through the Generating Antibiotics Incentives Now Act ('GAIN Act') that was signed into US law in 2012 as part of the FDA Safety and Innovation Act. SMT19969 is currently in a Phase 2 proof of concept trial that is being conducted in North America.
"Summit is delighted that our novel antibiotic SMT19969 for the treatment of C. difficile infection has received QIDP designation from the FDA under the GAIN Act," commented Glyn Edwards, Chief Executive Officer of Summit. "This status recognises the serious healthcare threat posed by pathogens such as C. difficile and it will confer a number of advantages that will accelerate the development of this promising and differentiated antibiotic with the potential to treat initial CDI and reduce the high rates of disease recurrence, the major clinical issue."
About the GAIN Act
The GAIN Act was signed into law in 2012 and provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases. The GAIN Act lists specific qualifying pathogens, including C. difficile and means new therapeutics to treat CDI are eligible for designation as QIDPs. A drug that receives QIDP designation is eligible for: i) Fast Track designation. This is intended to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions through more frequent meetings with the FDA and a rolling review of trial findings; ii) Priority Review that reduces to only six months the time taken by the FDA to review a drug marketing application; and iii) an additional five years of marketing exclusivity under the Hatch-Waxman Amendments upon the approval of a new drug application by the FDA.
About C. difficile Infection
C. difficile infection ('CDI') is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community. It is a serious illness caused by infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that disrupt the natural balance of the gastrointestinal (gut) flora allowing C. difficile to flourish. Existing CDI antibiotics cause further damage to the gut flora and are associated with high rates of recurrent disease. This is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. Recent years have seen a significant increase in CDI and means the disease has a high economic burden with the annual cost of care in the US alone estimated at over $4.8 billion.
About SMT19969
SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with high levels of antibacterial selectivity. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be safe and well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported which demonstrated that SMT19969 was highly sparing of gut flora. The Phase 2 proof of concept CoDIFy trial is currently being conducted in North America.
- END -
dreamcatcher
- 04 Sep 2014 07:10
- 182 of 213
Summit Corporation PLC : Half-yearly report
HUG
Summit Corporation plc
('Summit' or 'the Company')
INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 JULY 2014
Oxford, UK, 4 September 2014, Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its interim financial results for the six months ended 31 July 2014.
HIGHLIGHTS
Product Development
Duchenne Muscular Dystrophy
- SMT C1100 met its primary endpoints in a Phase 1b clinical trial in DMD patients with the utrophin modulator shown to be safe and well tolerated at all doses tested
- Potential indicator of SMT C1100 activity in the Phase 1b trial with a statistically significant reduction observed in the levels of three enzymes associated with muscle damage
- Next clinical trial in DMD patients to monitor dietary impact on SMT C1100 uptake expected to start in Q4 2014; it is planned to then enrol these patients into a Phase 2 open-label study
C. difficile Infection
- First patients enrolled and dosed in a Phase 2 clinical trial of the novel antibiotic SMT19969
- SMT19969 designated as a Qualified Infectious Disease Product ('QIDP') by the US FDA to provide accelerated development and market exclusivity benefits
- £1.9 million milestone payment received as part of the Wellcome Trust Translational Award
Corporate
- US operations established through opening of Cambridge, Massachusetts office
- Mr Erik Ostrowski appointed Chief Financial Officer, bringing experience in finance, operations and investment banking in the biotechnology and healthcare sector
- Mr Leopoldo Zambeletti appointed as a Non-Executive Director, adding additional experience in healthcare investment banking and product licensing and other strategic transactions
Financial
- Cash position at 31 July 2014: £17.4 million (31 January 2014: £2.0 million)
- £22.0 million (£20.7 million net of costs) financing completed in March 2014
- Increase in operational expenditure in-line with expectation and reflects the increase in product development activities
- Loss for the six months ended 31 July 2014 of £5.9 million (31 July 2013: £2.1 million)
Glyn Edwards, Chief Executive Officer of Summit commented: "Strong progress has been made during the first half of the year in the development of our DMD and CDI programmes as they are evaluated in patient clinical trials. Encouraging results were reported from the Phase 1b trial of the utrophin modulator SMT C1100 while the Phase 2 trial on our C difficile antibiotic SMT19969 enrolled and dosed its first patients."
"We look forward to an exciting period as we generate more data from clinical trials that we hope will provide a fuller understanding about the potential of these life-changing treatments for two serious diseases."
An analyst briefing conference call will be held at 12:30pm BST (07:30am ET) on Thursday, 4 September 2014. The call will be hosted by N+1 Singer and the dial-in details are as follows: +44 (0) 330 336 0007, access code: 428647.
- END -
dreamcatcher
- 04 Sep 2014 17:13
- 183 of 213
UPDATE - Summit plc looking forward to trials results
By John Harrington
September 04 2014, 1:36pm
'We look forward to an exciting period as we generate more data from clinical trials,” said Glyn Edwards, chief executive officer.
"We look forward to an exciting period as we generate more data from clinical trials,” said Glyn Edwards, chief executive officer.
---ADDS BROKER COMMENT AND SHARE PRICE---
Drug developer Summit (LON:SUMM) enters the second half of the year with a healthy cash position to support the execution of its clinical development plans.
Cash at the end of July stood at £17.4mln, up from £2.0mln a year earlier, following its massively oversubscribed £22mln fund raising in March.
The company is entering an important stage of its development, as reflected by the ramping up of research & development (R&D) expenditure in the first half of the year; spending on R&D rose to £4.9mln from £2.1mlm and was a major factor in a deeper loss of £5.9mln, versus a loss the year before of £2.1mln.
Such losses are par for the course for early stage drug development companies, and the focus of the results statement was understandably on progress made to date on the company’s two clinical programmes for Duchenne Muscular Dystrophy (DMD) and C. difficile infection (CDI).
Patient trials are either on-going or expected to start in the near future and will generate further data that should provide a fuller understanding of the potential of these life-changing treatments for two serious diseases, Summit said.
Regarding SMT C1100, Summit’s treatment for DMD, the next clinical trial in DMD patients to monitor dietary impact on Summit’s SMT C1100 uptake is expected to start in before the end of this year.
On the CDI front, the first patients have been enrolled and dosed in a phase II clinical trial of the novel antibiotic SMT 19969, and the drug was designated as a Qualified Infectious Disease Product earlier this year by the US Food & Drug
A £1.9 million milestone payment received as part of the Wellcome Trust Translational Award was also received in respect of the CDI programme.
Glyn Edwards, chief executive officer of Summit, said he is looking forward to an exciting period for Summit, and commented: "Strong progress has been made during the first half of the year in the development of our DMD and CDI programmes as they are evaluated in patient clinical trials. Encouraging results were reported from the Phase 1b trial of the utrophin modulator SMT C1100 while the Phase 2 trial on our C difficile antibiotic SMT19969 enrolled and dosed its first patients."
N+1 Singer described the results as “solid”, saying they highlight the strong progress being made by the company with its lead programmes.
“SMT C1100 is the first utrophin modulator to enter clinical trials in DMD, with the next clinical trial on track to commence in Q4 2014. There is currently no cure for DMD, a fatal muscle wasting disease that affects around 1 in 3,500 male births, and unlike other approaches in development, SMT C1100 can potentially be used by 100% of boys with DMD and in combination with other agents,” the broker noted, as it indicated it would not be making any major changes to its forecasts based on the interim results.
“SMT 19969 is currently in Phase II and on track to deliver top line data in H1 2015. C difficile infection is established as a major healthcare threat, with around 900,000 cases per annum in Europe and North America, and responsible for acute care costs of $4.8bn per annum in the USA alone.
“We remain highly positive on the group’s future prospects,” it added.
Shares in Summit were down 3.5p at 166p in afternoon trading.
skinny
- 08 Sep 2014 07:23
- 184 of 213
Summit Presents New Positive Preclinical Data on SMT19969 for C. difficile at ICAAC 2014
Oxford, UK, 8 September 2014 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy and C. difficile infection ('CDI'), reports new positive preclinical efficacy data on SMT19969, a novel and selective antibiotic for the treatment of CDI, at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy ('ICAAC 2014') held in Washington DC, USA from September 5-9 2014.
The data being presented is from a series of preclinical in vivo and in vitro efficacy studies whose results show that SMT19969 continues to display superiority over vancomycin, the current standard of care for the treatment of CDI. In comparison to vancomycin, SMT19969 provided increased survival rates and prevention of recurrent disease in vivo, displayed superior C. difficile killing, and reduced toxin B production.
Infectious diseases expert and hospital epidemiologist with a specialist interest in C. difficile disease, Dale Gerding MD, Professor of Medicine at Loyola University Stritch School of Medicine commented, "C. difficile infection is associated with high levels of recurrent disease and, to reduce this, it is imperative that antibiotics which minimise impact on the natural bacterial flora of the gut are used. The gut flora and its protective role are typically disrupted in CDI patients. Antibiotics that have a targeted spectrum of activity, such as SMT19969, could allow restoration of the protective flora to happen sooner and so reduce disease recurrence. The results on SMT19969 are encouraging and it warrants further evaluation in patient clinical trials."
Glyn Edwards, Chief Executive Officer of Summit added, "These results further illustrate that SMT19969 has potential to be a new and differentiated antibiotic for the treatment of initial CDI infection and for the prevention of recurrent disease, the key clinical issue. It is an exciting time in the development of SMT19669 with patients now being enrolled into a Phase 2 proof of concept trial as we work towards establishing the potential of this highly selective antibiotic for the treatment of CDI."
The results were detailed in five poster presentations given by Summit and its collaborators that include Dr Joseph Blondeau (Royal University Hospital and the University of Saskatchewan, Canada), Professor Kevin Garey (University of Houston College of Pharmacy, Houston, US) and Professor Nigel Minton (School of Life Sciences, University of Nottingham, UK). The details of the presentations were as follows:
skinny
- 08 Oct 2014 07:28
- 185 of 213
SUMMIT REPORTS POSITIVE DATA ON ITS UTROPHIN MODULATION PROGRAMME FOR THE TREATMENT OF DMD AT 2014 WMS CONGRESS
Phase 1b clinical trial data on lead utrophin modulator SMT C1100
Positive preclinical data unveiled on second generation candidates
Oxford, UK, 8 October 2014 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, reports clinical data on SMT C1100, the Company's lead utrophin modulator, highlighting its safety profile and further detailing the observed reduction in enzymes associated with muscle damage in a Phase 1b study in boys with DMD. In addition, Summit is unveiling new positive preclinical data on its second generation utrophin modulator programme for the treatment of DMD.
All data are being presented at the 19th International World Muscle Society Congress ('WMS') being held in Berlin Germany from 7-11 October 2014.
Glyn Edwards, Chief Executive Officer of Summit commented, "SMT C1100 is paving the way in the clinic for utrophin modulation and the initial signs of activity point to this mechanism as a potential treatment for all boys with DMD. Our second generation utrophin modulators build on this mechanism with the new data illustrating how they increase utrophin protein levels and improve muscle health, while having enhanced drug properties compared to the first generation drug SMT C1100."
"This exciting progress shows SMT C1100 has the potential to become the first utrophin modulator drug to treat all DMD patients, to be followed by second generation candidates with improved properties, as we seek to change the treatment paradigm for this devastating condition."
The data on the second generation programme comprise results from in vivo and in vitro studies that highlight the promising profile of two lead candidates as potential disease modifying treatments:
Significant improvement in systemic exposure in vivo compared to first generation utrophin modulator SMT C1100 with blood plasma levels 10-40 times higher following oral dosing;
Modulation of utrophin expression in vivo with an increase in protein levels observed in skeletal muscle, diaphragm and heart compared to the control;
Significant improvement in disease pathology with reduction in muscle fibre fibrosis ('scarring') and membrane damage;
Improvement in muscle health indicated by a significant reduction in the number of regenerating muscle fibres;
Protection of muscle function with the increased utrophin protein levels resulting in significant improvement in muscle membrane stability and resistance to damage.
These studies were conducted as part of the UtroDMD Alliance, a collaboration to develop utrophin modulator drugs for the treatment of DMD.
dreamcatcher
- 25 Nov 2014 19:32
- 186 of 213
BioMarin deal is positive for Summit, says N+1 Singer
By Giles Gwinnett
November 25 2014, 12:04pm
BioMarin said it would pay US$17.75 for each Prosensa share or around US$680mln - a 55.2% premium on Friday's closing price
The planned acquisition of Dutch pharma group Prosensa by rare disease giant BioMarin is positive for Summit Corp (LON:SUMM) and highlights the potential value of Duchenne Muscular Dystrophy (DMD)-focused firms, says N+1 Singer.
BioMarin said it would pay US$17.75 for each Prosensa share or around US$680mln - a 55.2% premium on Friday's closing price.
Analyst Sheena Berry noted there was currently no cure for DMD, which is classed as an orphan disease in the US and Europe, and affects around 1 in 3,500 male births.
Prosensa’s lead drug candidate can potentially treat 13% of the DMD population whereas Summit’s lead DMD programme - utrophin modulator SMT C1100 - can potentially be applied to 100% and in combination with other agents," she added.
Prosensa's lead candidate is drisapersen, which has completed phase III trials and the firm is targeting a filing for a new drug with the FDA by the end of this year.
DMD is caused by mutations in the dystrophin gene, which contains the instructions for making dystrophin, which acts as a shock absorber to prevent damage when muscles contract.
It is thought that utrophin, a protein naturally present in the body in small amounts, may be able to make up for the lack of dystrophin in boys with DMD since both proteins appear to have very similar functions.
Berry said the broker continues to be positive on the utrophin modulation programme for DMD.
"The compound completed a Phase Ib trial earlier in the year, meeting its primary endpoint as well as having a positive impact on enzyme markers.
"SMT C1100 is expected to enter its next clinical trial in DMD imminently and we anticipate results during the course of 2015. Our forecasts assume peak sales in SMT C1100 of around US$2bn four years after market entry and assume a significant partnering deal in the group’s 2017 financial year."
The broker estimates Summit's revenue of £2.3mln in 2015, rising to £50.5mln in 2017.
Summit shares added 0.39% to 128.5p on Tuesday.
dreamcatcher
- 11 Dec 2014 17:40
- 187 of 213
Summit gets go-ahead for DMD dietary trial
By Philip Whiterow
December 11 2014, 7:58am
'The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term.'
"The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term."
Summit (LON:SUMM) has received approval from the UK authorities to start a Phase 1b modified diet trial of SMT C1100, its treatment for muscle wasting disease Duchenne Muscular Dystrophy (DMD).
The new trial will assess specific dietary guidance to improve drug absorption and test the drug on enzyme markers of muscle health in 12 boys aged between 5-13. Top-line data from the trial is expected in mid-2015.
Glyn Edwards, chief executive, said: "We believe it is possible to enhance absorption of SMT C1100 through dietary means and this new patient trial is designed to test this so that we can confidently evaluate the efficacy of utrophin modulation in subsequent clinical trials."
“We believe that utrophin modulation has the opportunity to benefit all boys with DMD and we are working to ensure this molecule has the best chance to reach the market through a well-designed clinical path.
"The initiation of this trial means our DMD and CDI programmes have the potential to achieve important clinical milestones in the near-term with both expected to report top-line data in mid-2015."
The modified diet trial will be conducted at four NHS hospitals and, if successful, will be followed by a Phase 2 open label trial to generate longer-term efficacy and safety data on SMT C1100.
dreamcatcher
- 19 Dec 2014 15:57
- 188 of 213
Summit Considering Potential US Registered Publ...
HUG
Summit Corporation plc
('Summit' or 'the Company')
SUMMIT CONSIDERING POTENTIAL U.S. REGISTERED PUBLIC OFFERING AND STOCK EXCHANGE LISTING
Oxford, UK, 19 December 2014 - Summit (AIM: SUMM) announces that it is considering the possibility of a registered public offering of its ordinary shares in the United States under the U.S. Securities Act of 1933, as amended, and a related listing on a U.S. stock exchange to supplement its current listing on the AIM market of the London Stock Exchange. Summit has not made any decision regarding the timing or the terms of the potential offering, and there is no certainty that the offering will take place.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities.
- END -
dreamcatcher
- 02 Feb 2015 15:04
- 189 of 213
Summit Corporation PLC : Third Quarter Results ...
HUG
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
Summit Corporation plc
('Summit' or the 'Company')
THIRD QUARTER RESULTS FOR THE NINE MONTHS ENDED 31 OCTOBER 2014
Oxford, U.K., 2 February 2015 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), announces financial results for the third quarter and nine months ended 31 October 2014. The Company has also separately announced today its proposed offering of American Depositary Shares in the United States, on the NASDAQ Global Market, to complement the continuing trading of Summit's ordinary shares on AIM.
HIGHLIGHTS
DUCHENNE MUSCULAR DYSTROPHY PROGRAMME
Received regulatory and ethics committee approval to commence Phase 1b modified diet clinical trial of lead utrophin modulator SMT C1100; Top-line data expected to be reported in mid-2015
If successful, plan to initiate Phase 2 Open Label clinical trial in H2 2015 and placebo controlled Phase 2 clinical trial of SMT C1100 in early 2016
On-going development of second generation utrophin modulators with positive preclinical data unveiled at the 19th World Muscle Society Congress
C. DIFFICILE INFECTION PROGRAMME
Phase 2 Proof of Concept clinical trial on-going in U.S. and Canada
Enrolment and dosing of patients underway; top line data now expected in H2 2015
Positive preclinical efficacy data presented at the 54th ICAAC conference
OPERATIONAL HIGHLIGHTS
Proposed offering of American Depositary Shares in the United States and listing on the NASDAQ Global Market to complement the Company's current AIM listing, subject to shareholder approval (see separate announcement)
Proposed change of registered name to Summit Therapeutics plc
Appointment of Valerie Andrews as a Non-Executive Director
FINANCIAL HIGHLIGHTS
Cash and cash equivalents at 31 October 2014 of £15.0 million compared to £2.0 million at 31 January 2014
Operational expenditure in-line with expectation and reflects the increase in product development activities
Loss for the nine months ended 31 October 2014 of £8.3 million compared to £3.8 million for the nine months ended 31 October 2013
Mr Glyn Edwards, Chief Executive Officer of Summit commented, "Summit continues to make progress on a number of fronts. The announcement today of a proposed listing on NASDAQ is intended to provide greater access to a wider set of healthcare investors, generate greater liquidity in the Company's shares, and increase awareness of Summit in geographies outside of the U.K., particularly in the United States. As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and U.S. public offering are also expected to support the on-going development of our DMD and CDI programmes. We expect to report top line data from patient clinical trials in each of these programmes during 2015."
Notes to Editors
About Summit
Summit is an Oxford, U.K. based drug discovery and development company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is quoted on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
//////////////////////////////////////////////////////////////////////////////////////////////////
Summit shares climb as unveils US listing plans
By Giles Gwinnett
February 02 2015, 10:47am
Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US
Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US
Shares in drug developer Summit (LON:SUMM) jumped over 10% on Monday as it told investors it continues to make progress on a number of fronts and unveiled plans to list on the NASDAQ exchange in the US.
The firm has filed for a proposed offering of American Depository shares to be listed on the exchange under the symbol 'SMTT'. The size of the offering and final timing has yet to be determined.
Summit is developing treatments for muscle wasting disease Duchenne Muscular Dystrophy (DMD) and C. difficile infection.
Chief executive Glyn Edwards told investors the proposed listing was aimed at providing greater access to a "wider set of healthcare investors, generate greater liquidity in the company's shares, and increase awareness of Summit in geographies outside of the UK".
"As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and US public offering are also expected to support the on-going development of our DMD and CDI programmes," he said.
"We expect to report top line data from patient clinical trials in each of these programmes during 2015," he added.
Highlights of the nine months to end October last year saw the company receive approval to commence a Phase 1b clinical trial of lead utrophin modulator SMT C1100 for Duchenne's and top line data is expected in mid-2015.
On the C-diff programme, a phase 2 Proof of Concept clinical trial IS on-going in the US and Canada and enrolment and dosing of patients is underway with top line data expected in the second half of 2015.
Operational expenditure for the nine months was in-line with expectations, Summit said, reflecting the increase in product development activities.
Research and development costs increased to £7.6 million from £4.4 million for the comparable period in 2013.
The loss for the period came in at £8.3 million compared to £3.8 million in 2013.
Cash and equivalents as at October 31 last year were of £15 million compared to £2 million on Jan 31, 2014.
Broker N+1 Singer noted the acquisition of Prosensa at the end of last year for up to US$840mln highlighted the "significant value" in DMD companies and provides a positive read-across to Summit and its utrophin modulation programme.
Prosensa is a company developing a compound for Duchenne Muscular Dystrophy that was previously listed on NASDAQ.
!Its lead drug candidate can potentially treat 13% of the DMD population where Summit’s lead DMD programme, SMT C1100, can potentially be used by 100% of boys with DMD and in combination with other agents," noted N+1.
"Summit’s third quarter results indicate that the group’s two clinical programmes continue to progress with data expected from mid-2015.
“We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."
Summit shares added 10.59% to 141p.
dreamcatcher
- 20 Feb 2015 07:08
- 190 of 213
Summit Announces First Patients Dosed in Phase ...
HUG
Summit Therapeutics plc
('Summit' or the 'Company')
SUMMIT ANNOUNCES THE FIRST PATIENTS DOSED IN PHASE 1B MODIFIED DIET CLINICAL TRIAL OF SMT C1100 FOR TREATMENT OF DMD
Oxford, UK, 20 February 2015 - Summit Therapeutics plc (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection, announces that the first patients with DMD have been enrolled and dosed in a Phase 1b modified diet clinical trial of the orally administered, small molecule utrophin modulator SMT C1100.
"We believe that utrophin modulation has the potential to benefit all patients with DMD, irrespective of the underlying fault in the dystrophin gene causing the disease, and this new trial forms part of our broader clinical development path that seeks to provide this drug with the best chance of reaching the market," commented Glyn Edwards, Chief Executive Officer of Summit. "We look forward to reporting data from this study in Q3 2015."
About the Phase 1b Modified Diet Clinical Trial
The Phase 1b trial is a randomised, placebo controlled study being conducted in paediatric patients with DMD. This new trial aims to increase the blood plasma levels of SMT C1100 compared to those observed in the previous open label Phase 1b trial completed in 2014 by providing patients with specific dietary guidance on recommended balanced proportions of fat, protein and carbohydrates. The trial is also evaluating the potential impact of SMT C1100 on enzyme biomarkers that are related to muscle health, and further evaluating the safety and tolerability of the drug.
The trial is being conducted in the UK and is enrolling a total of 12 patients aged between 5 and 13 years, divided equally into three dose cohorts. The trial will include three randomised 14-day treatment periods during which each patient will receive two different doses of SMT C1100 and a placebo control. There will be a 14-day wash-out period between each of the three treatment periods.
Top-line data from the Phase 1b modified diet trial are expected to be reported in Q3 2015. If successful, Summit plans to initiate a Phase 2 open label trial in DMD patients designed to evaluate the longer-term effects of SMT C1100 on muscle health, function and safety. Summit also plans to conduct a larger multinational Phase 2 placebo controlled trial.
- END -
dreamcatcher
- 23 Feb 2015 16:11
- 191 of 213
UPDATE - Summit Therapeutics hires new director as pursues US listing
By Giles Gwinnett
February 23 2015, 10:15am
Broker N+1 Singer said: 'Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group.'
Broker N+1 Singer said: "Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."
---Adds share price and broker comment---
Pharma and biotech specialist David Wurzer has been hired as a non-exec director at drug developer Summit Therapeutics (LON:SUMM) as it continues to pursue a NASDAQ listing in the US.
Summit chairman Frank Armstrong said: "David's expertise in financial matters and experience in working for US listed companies will be extremely valuable in supporting the future growth of the company."
Wurzer was executive vice president, treasurer and CFO of NASDAQ listed biotechnology company CuraGen Corporation between 1997 and 2008. He also held a number of positions at Value Health Inc from 1991 to 1997.
The 56-year-old is currently the executive vice president and chief investment officer at Connecticut Innovations - a state funded venture capital fund.
As reported on February 2, the group has filed for a proposed offering of American Depository shares to be listed on the exchange under the symbol 'SMTT'.
Today, it said it filed on Friday an amended registration statement, which included a preliminary prospectus for the offering.
Summit is advancing therapies for Duchenne Muscular Dystrophy (DMD) and C. difficile infection (CDI).
Broker N+1 Singer said: "Top line data from the group’s two clinical programmes is expected in H2 2015. We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."
Shares added 2.37% to 151p.
dreamcatcher
- 05 Mar 2015 20:19
- 192 of 213
UPDATE - Summit NASDAQ listing begins as unveils US$34.2mln fundraise
By Giles Gwinnett
March 05 2015, 3:22pm
The initial public offering will see 3.45mln American Depositary shares offered at a price of US$9.90 each to raise around US$34mln
The initial public offering will see 3.45mln American Depositary shares offered at a price of US$9.90 each to raise around US$34mln
Drug developer Summit (LON:SUMM) reached another milestone on Thursday as it listed on the NASDAQ exchange in the US and brought in US$34.2mln alongside the IPO to fund its research.
The initial public offering (IPO) saw 3.45mln American Depositary shares (ADS) offered at a price of US$9.90 each to raise around US$34.2mln. Shares began trading under the symbol SMMT and were unchanged at the time of writing.
The group's shares continue to trade on AIM and the offer price is equivalent to around £1.30p a share - about 20% lower than Wednesday night's London closing price of 161p.
"Today's successful listing on NASDAQ achieves a significant milestone that we believe will support the company's future growth and development," said Summit chief executive Glyn Edwards.
"We believe being dual-listed will enhance the profile of Summit amongst the investment community and will mean we are better able to continue advancing our mid-stage clinical programmes in Duchenne muscular dystrophy [DMD] and C. difficile infection [CDI]."
Edwards believes the proposed listing will provide greater access to a "wider set of healthcare investors, generate greater liquidity in the company's shares, and increase awareness of Summit in geographies outside of the UK".
"As a complement to Summit's current quotation on AIM, the proposed NASDAQ listing and US public offering are also expected to support the on-going development of our DMD and CDI programmes," he said.
Summit is developing treatments for muscle wasting disease Duchenne Muscular Dystrophy and hospital super-bug C. difficile infection. It has received approval to start a Phase 1b clinical trial of lead utrophin modulator SMT C1100 for Duchenne's and top line data is expected in mid-2015.
On the C-diff programme, a phase 2 proof of concept clinical trial is on-going in the US and Canada and enrolment and dosing of patients is underway with top line data expected in the second half of 2015.
Broker N+ 1 Singer highlighted that another Duchenne Muscular Dystrophy firm - Prosensa - was previously listed on Nasdaq and snapped up at the end of 2014 for up to US$840mln.
It believes the deal revealed the significant value in DMD companies and provides a "positive read-across" to Summit.
"There is currently no cure for DMD, a fatal muscle wasting Orphan disease in the US and Europe, which affects around 1 in 3,500 male births. Prosensa’s lead drug candidate can potentially treat 13% of the DMD population where Summit’s lead DMD programme, SMT C1100, can potentially be used by 100% of boys with DMD and in combination with other agents," it said.
"We continue to be upbeat about Summit’s future prospects and believe 2015 could be a very positive year for the group."
On AIM, summit shares eased 8.39% to stand at 147.5p.
js8106455
- 29 Apr 2015 11:47
- 193 of 213
Watch: Summit plc - Master Investor 2015
click here
dreamcatcher
- 30 Apr 2015 20:22
- 194 of 213
Summit Therapeutics Granted Key Patent for Nove...
HUG
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT THERAPEUTICS GRANTED KEY PATENT FOR NOVEL ANTIBIOTIC SMT19969 FOR THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 30 April 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection ("CDI") announces that the United States Patent and Trademark Office has issued a patent that protects the use of SMT19969 in the treatment of CDI.
United States Patent number 8,975,416 is entitled "Antibacterial Compounds" and will provide a period of exclusivity for the use in the United States of the small molecule antibiotic SMT19969 in the treatment of CDI through until at least 1 December 2029. Patent protection has previously been granted for SMT19969 in the treatment of CDI in a number of other countries including Japan.
"The grant of this key patent for SMT19969 in one of the major commercial markets represents a critical component in our strategy for advancing this highly selective antibiotic for the treatment of CDI. SMT19969 has the potential to treat initial infection and reduce rates of disease recurrence by being highly sparing of healthy gut flora," commented Glyn Edwards, Chief Executive Officer of Summit. "Through the grant of this patent the intellectual property estate protecting SMT19969 has been significantly strengthened as we continue to evaluate this promising antibiotic in Phase 2 proof of concept patient clinical trials. Data are expected from the trial in the second half of this year."
- END -
skinny
- 19 Jun 2015 12:07
- 195 of 213
dreamcatcher
- 07 Jul 2015 20:37
- 196 of 213
Summit Therapeutics Granted Key Patent by Europ...
HUG
Summit Therapeutics plc
('Summit' or the 'Company')
SUMMIT THERAPEUTICS GRANTED KEY PATENT BY EUROPEAN PATENT OFFICE FOR UTROPHIN MODULATOR SMT C1100 IN THE TREATMENT OF DMD
Patent emerges from opposition period with no opposition filed with EPO
Oxford, UK, 7 July 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, announces that the European Patent Office ('EPO') has granted a composition of matter patent for the small molecule utrophin modulator SMT C1100 and that the period of opposition for this patent has now expired with no opposition having been filed. The patent protects SMT C1100 and its use in the treatment of the fatal muscle wasting disease DMD.
"This is a cornerstone patent for SMT C1100, and its grant and emergence from the opposition period in a major commercial market, represents a crucial part in our strategy for advancing this promising utrophin modulator therapy for DMD," commented Glyn Edwards, Chief Executive Officer of Summit. "The grant of this European patent, combined with its grant in other major territories including the United States and Japan, ensures strong intellectual property protection for this investigational drug that has the potential to improve the lives of all patients affected by DMD."
The patent (European patent number 1986633) is entitled "Treatment of Duchenne Muscular Dystrophy" and will provide a period of exclusivity for SMT C1100 through until 2027, with the possibility of a longer effective term subject to obtaining a Supplementary Protection Certificate on marketing approval. The patent has also been validated in all available contracting states to the European Patent Convention, and so is now in force in all major European states including the United Kingdom, Germany, France, Spain and Italy.
SMT C1100 is the Company's most advanced utrophin modulator and forms part of the Company's wider pipeline of utrophin based therapies that are in development. SMT C1100 is currently in a Phase 1b clinical trial in patients with DMD with top line results expected to be reported during Q3 2015.
- END -
dreamcatcher
- 08 Jul 2015 15:33
- 197 of 213
Summit Therapeutics Receives Fast Track Designa...
HUG
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT THERAPEUTICS RECEIVES FDA FAST TRACK DESIGNATION FOR NOVEL ANTIBIOTIC SMT19969 IN THE TREATMENT OF C. DIFFICILE INFECTION
Oxford, UK, 8 July 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), announces that the US Food and Drug Administration ('FDA') has granted Fast Track designation for the Company's novel antibiotic for the treatment of CDI. SMT19969 is a highly selective antibiotic candidate currently being evaluated in a Phase 2 proof of concept trial in CDI patients in North America.
"Fast Track designation recognises the serious healthcare threat posed by C. difficile due to a high rate of disease recurrence, the key clinical issue in treating CDI, and underscores the importance of developing a candidate like SMT19969, which has significant potential to address both the initial infection and recurrence," said Glyn Edwards, Chief Executive Officer of Summit.
Fast Track designation is awarded to expedite the development and regulatory review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. SMT19969 is also designated a Qualified Infectious Disease Product ('QIDP') under the Generating Antibiotic Incentives Now Act ('GAIN Act'), which allows Summit to benefit from a number of incentives supporting development of new antibiotics, and if SMT19969 receives marketing approval from FDA, a five year extension of market exclusivity.
- END -
dreamcatcher
- 13 Jul 2015 15:58
- 198 of 213
Summit Therapeutics Publishes Preclinical Data ...
HUG
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT THERAPEUTICS PUBLISHES PRECLINICAL DATA ON DISEASE-MODIFYING POTENTIAL OF UTROPHIN MODULATION IN DMD
Publication in Human Molecular Genetics supports utrophin modulation as mechanism to treat DMD regardless of mutation status
Oxford, UK, 13 July 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, today announced the publication of preclinical data on the disease-modifying potential of utrophin modulation in the treatment of DMD.
Upon modulation of utrophin protein with the second generation utrophin modulator SMT022357, in vivo models of DMD showed significantly improved muscle stability and a marked reduction of muscle regeneration, necrosis and fibrosis, the hallmark of DMD pathology. Interestingly, researchers found that utrophin was expressed across the entire length of the muscle fibre, likely contributing to its ability to significantly reduce disease progression in animal models. The data were published in the August 1, 2015 issue of Human Molecular Genetics
"These data strongly support utrophin modulation as a potentially valuable mechanism to treat DMD and highlight the importance of the continued development of second-generation, orally available utrophin modulator candidates," said Professor Dame Kay E. Davies of the University of Oxford. "There is tremendous therapeutic potential for utrophin modulation in this devastating disease because there is currently no approved disease modifying therapy applicable to all patients with DMD and many other candidates in clinical development are restricted to a single mutation."
Utrophin is structurally and functionally similar to dystrophin, the protein which is lacking in boys with DMD, and is normally present during muscle development and repair. By modifying utrophin to be continuously produced in boys with DMD, this potentially disease-modifying approach could circumvent the need for dystrophin in all patients with this devastating disease. Summit is currently in Phase 1b clinical studies with SMT C1100, a first-generation utrophin modulator. The paper, "Second-generation compound for the modulation of utrophin in the therapy of DMD," describes the significant disease-modifying potential of SMT022357, a structurally related compound to SMT C1100, which has enhanced pharmaceutical properties.
In the reported study, SMT022357 treatment for five weeks resulted in increased utrophin expression, localized along the entire length of the muscle fibre membrane in both slow- and fast-twitch muscles. This addressed the primary cause of fibre degeneration and increased muscle stability in hind-limb muscles of the mdx mouse, which resulted in reduced regeneration and necrosis, enhanced protection of the muscle against contraction-induced damage and improved muscle function. Utrophin expression in the heart and diaphragm is highly desirable in DMD as loss of function in these organs is life-limiting in DMD. Treatment with SMT022357 resulted in significant increases in utrophin expression in both the heart and diaphragm. Notably SMT022357 treatment resulted in reduced fibrosis in the diaphragm, a significant observation due to the disease pathology in the diaphragm of the mdx model closely resembling that of DMD patients. These data suggest that SMT022357 results in significant improvement in the pathology of DMD and could represent a disease-modifying therapeutic strategy for all patients with DMD.
The paper was authored by Simon Guiraud, Sarah E. Squire, Benjamin Edwards, Huijia Chen, David T. Burns, Nandini Shah, Arran Babbs, Stephen G. Davies, Graham M. Wynne, Angela J. Russell and Kay E. Davies of the University of Oxford, and David Elsey, Francis X. Wilson and Jon M. Tinsley of Summit Therapeutics (reference: Hum. Mol. Genet. (2015) 24 (15): 4212-4224).
- END -
skinny
- 14 Jul 2015 12:51
- 199 of 213
dreamcatcher
- 17 Aug 2015 18:08
- 200 of 213
Summit Therapeutics Announces Phase 1b Modified...
HUG
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT THERAPEUTICS ANNOUNCES PHASE 1B MODIFIED DIET CLINICAL TRIAL ACHIEVES PRIMARY OBJECTIVE IN DUCHENNE MUSCULAR DYSTROPHY
Primary Objective Met; Plasma Absorption of SMT C1100 Observed at a Level Suitable for Further Development
SMT C1100 to Progress into Phase 2 Open-label Trial
Conference Call Scheduled for 1:00pm BST / 8:00am EDT
Oxford, UK, 17 August 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, announces that its Phase 1b modified diet clinical trial of SMT C1100 for the treatment of DMD met its primary objective with half of the patients who received the higher dose of SMT C1100 achieving desired plasma levels while following specific dietary guidance. Based on these results, Summit will advance SMT C1100 into a Phase 2 open-label clinical trial.
The Phase 1b clinical trial was designed to increase plasma levels of SMT C1100 in patients by recommending a diet with balanced proportions of fat, proteins and carbohydrates, combined with consuming a small glass of full fat, whole milk at the time of dosing. Initial analysis shows six of 12 patients achieved the desired plasma level after receiving a 2,500 mg dose of SMT C1100 twice daily for 14 days. In a prior Phase 1b trial, only two of 12 patients dosed with SMT C1100 achieved the desired plasma level. SMT C1100 was well tolerated at all doses tested in the modified diet trial with no serious adverse events reported. This outcome increases the human safety database for this investigational drug. SMT C1100 is a small molecule utrophin modulator being developed for the potential treatment of all patients with DMD. SMT C1100 has received orphan drug designation in the US and Europe.
"DMD has a devastating impact on its patients and families, and current treatment options are merely palliative in nature or are only applicable to small subsets of patients. A universal DMD treatment, like SMT C1100 if successfully developed, would have a broad impact for these patients and families, either alone or in combination with other DMD therapies," said Principal Investigator Professor Francesco Muntoni from Great Ormond Street Hospital, London. "I am, therefore, looking forward to future clinical studies with SMT C1100."
"These data clear an important hurdle in the development of SMT C1100 by demonstrating it is a viable drug candidate to bring proof-of-concept for the Company's burgeoning utrophin modulator pipeline and more importantly, hope to all patients and their families living with this devastating disease," said Glyn Edwards, Chief Executive Officer of Summit. "Our priority is advancing SMT C1100 efficiently through future patient clinical trials designed to evaluate the potential clinical benefit of this promising treatment, and this will start with an open-label Phase 2 trial that is expected to start by the end of this year."
The trial also measured enzyme biomarkers of muscle damage, such as creatine kinase. In this modified diet study, there was no change in the enzyme levels when patients received SMT C1100 compared to when they received a placebo. The Company plans to evaluate creatine kinase as well as additional biomarkers over a longer duration of exposure to SMT C1100 in the upcoming Phase 2 open-label trial.
Summit plans to commence the Phase 2 open-label trial during the fourth quarter of 2015. The trial will evaluate the longer-term benefits of SMT C1100 on muscle health, function and safety. Further details of the trial will be provided at a future date.
Conference Call
Summit will host a conference call and webcast to discuss the results of the Phase 1b modified diet trial today 17 August 2015 at 1:00pm BST / 8:00am EDT. To participate in the conference call please dial +44 (0)20 3427 1902 (UK and international participants) or +1 646 254 3360 (US local number) and use the conference confirmation code 6476637. Investors may also access a live audio webcast of the call via the investors section of the Company's website www.summitplc.com. A replay of the webcast will be available shortly after the presentation finishes.
About the Phase 1b Modified Diet Trial
The Phase 1b randomised, placebo controlled clinical trial was designed to evaluate the blood plasma levels of SMT C1100 in paediatric patients with DMD. Patients and their caregivers were provided with specific dietary guidance on recommended balanced proportions of fats, proteins and carbohydrates. The trial enrolled a total of 12 patients aged between 5 and 13 years, divided equally into three dose cohorts, at trial sites in the UK. Patients were randomised to three groups over 14-day treatment periods during which each patient received two different doses of SMT C1100 and a placebo control. There was a wash-out period of at least 14 days in between each of the treatment periods. The Company is still evaluating the full results of the trial. Full data from this trial are expected to be presented at an upcoming medical meeting.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000 boys in the developed world. The disease is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin mutation. It is also expected that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
dreamcatcher
- 27 Aug 2015 20:16
- 201 of 213
Summit Therapeutics Reports Financial Results f...
HUG
Summit Therapeutics plc
('Summit' or the 'Company')
SUMMIT THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED 31 JULY 2015 AND OPERATIONAL PROGRESS
Oxford, UK, 27 August 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its financial results for the second quarter and half-year ended 31 July 2015.
Mr Glyn Edwards, Chief Executive Officer of Summit commented: "We have made very substantial progress with our utrophin modulator programme to treat boys with DMD with the recent announcement that our lead candidate, SMT C1100, achieved its primary objective in a Phase 1b clinical trial, allowing us to advance this molecule into a Phase 2 open-label trial that is expected to start by the end of this year. We further strengthened this programme with the publication of data on a second-generation utrophin modulator demonstrating its disease-modifying potential in animal models of this devastating disease. Importantly, we also received Fast Track designation from the US FDA for SMT19969 in CDI, highlighting the promise of our novel antibiotic treatment with the potential to address disease recurrence, the key clinical issue of CDI. With top-line data from our ongoing Phase 2 proof of concept trial in CDI expected to report in the fourth quarter of 2015, we continue to be excited about progress in both of our clinical programmes."
RECENT OPERATIONAL HIGHLIGHTS
Utrophin Modulation Programme for DMD:
SMT C1100 Highlights
Phase 1b modified diet clinical trial achieved primary objective in DMD
Plasma absorption of SMT C1100 observed at a level suitable for further development
SMT C1100 to progress into Phase 2 open-label clinical trial planned to commence in Q4 2015
Key composition of matter patent granted by European Patent Office for SMT C1100
Utrophin Modulation Pipeline
Positive preclinical data published on second-generation utrophin modulator showing increase in utrophin expression along entire length of muscle fibre, reduction in disease pathology and improvement in muscle function
CDI Programme:
SMT19969 Highlights
Phase 2 proof of concept clinical trial of novel antibiotic SMT19969 against vancomycin on-going with top-line data expected to be reported in Q4 2015
SMT19969 granted Fast Track status by the US Food and Drug Administration
Grant of key patent in the US protecting the use of SMT19969 in the treatment of CDI
FINANCIAL HIGHLIGHTS
Cash and cash equivalents at 31 July 2015 of £26.4 million compared to £11.3 million at 31 January 2015
Loss for the three months ended 31 July 2015 of £4.0 million compared to a loss of £3.3 million for the three months ended 31 July 2014
Initial Public Offering of American Depositary Shares in the US completed in March 2015 raising gross proceeds of $39.3 million
dreamcatcher
- 03 Sep 2015 17:56
- 202 of 213
dreamcatcher
- 10 Sep 2015 17:53
- 203 of 213
dreamcatcher
- 30 Sep 2015 18:35
- 204 of 213
dreamcatcher
- 26 Sep 2016 13:15
- 205 of 213
Proactive investor - Summit Therapeutics PLC (LON:SUMM), up 10% to 140.5p. Said this morning that its treatment for Duchenne muscular dystrophy has received fast-track designation from the US FDA.
dreamcatcher
- 04 Oct 2016 17:02
- 206 of 213
Sarepta Therapeutics and Summit Enter into Excl...
GNW
Sarepta Therapeutics and Summit Enter into Exclusive License and Collaboration Agreement for European Rights to Summit's Utrophin Modulator Pipeline for the Treatment of Duchenne Muscular Dystrophy
Sarepta and Summit collaborate to advance the development of novel therapies for patients with Duchenne muscular dystrophy
Summit receives $40 million upfront, with potential future ezutromid-related milestone payments totalling up to $522 million plus royalties
Sarepta and Summit to share research and development costs
Sarepta also receives option for Latin American rights
Cambridge, MA, and Oxford, UK, 4 October 2016 - Sarepta Therapeutics (NASDAQ: SRPT) and Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that they have entered into an exclusive license and collaboration agreement granting Sarepta rights in Europe, as well as in Turkey and the Commonwealth of Independent States ('the licensed territory'), to Summit's utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of Duchenne muscular dystrophy ('DMD'). As part of the agreement, Sarepta also obtains an option to license Latin American rights to Summit's utrophin modulator pipeline. Summit retains commercialization rights in all other countries.
Utrophin modulation is a potential disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, regardless of their underlying dystrophin gene mutation. Ezutromid is currently in a Phase 2 proof of concept trial called PhaseOut DMD.
"This partnership with Summit Therapeutics furthers our commitment to invest in innovative approaches to treating Duchenne and supports our common goal of improving the lives of patients with DMD," said Edward Kaye, M.D., Sarepta's Chief Executive Officer. "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
"Sarepta Therapeutics has paved the way in the development of disease-modifying therapies for DMD with the first FDA-approved drug in this disease area, making them a strong strategic partner to support our utrophin modulator pipeline," commented Glyn Edwards, Chief Executive Officer of Summit. "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline. We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
Under the terms of the agreement, Summit will receive an upfront fee of $40 million. In addition, Summit will be eligible for future ezutromid related development, regulatory and sales milestone payments totalling up to $522 million, including a $22 million milestone upon the first dosing of the last patient in Summit's PhaseOut DMD trial, and escalating royalties ranging from a low to high teens percentage of net sales in the licensed territory. Summit will also be eligible to receive development and regulatory milestones related to its next-generation utrophin modulators. Sarepta and Summit will share specified utrophin modulator-related research and development costs at a 45%/55% split, respectively, beginning in 2018. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties.
Sarepta and Summit will host an update call for the Duchenne community on Monday, October 10 at 12:00 EDT. Details of the call can be accessed by visiting http://www.parentprojectmd.org/communitycall.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to treat all patients with DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company's lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration ('FDA') and the European Medicines Agency have granted orphan drug status to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation and Rare Pediatric Disease designation by the FDA.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
About Sarepta
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.
Contacts
dreamcatcher
- 04 Oct 2016 17:04
- 207 of 213
Summit Therapeutics shares shoot up 90% after it inks $522mln Sarepta deal
Share
16:15 04 Oct 2016
Summit has inked a deal that could potentially be worth more than half a billion dollars.
The company is developing what it hopes is a breakthrough for a hard to treat disease that affects boys.
Shares in Summit Therapeutics (LON:SUMM) shot up 90% after it confirmed it had signed a licensing deal with the US biotech Sarepta Therapeutics (NASDAQ:SRPT) worth up to US$522mln.
The pair will collaborate on Summit’s potentially breakthrough treatment for Duchenne muscular dystrophy (DMD), a muscle wasting disease that affects boys.
The UK drug developer gets an immediate US$40mln and US$22mln when the last patient in the company’s phase II trial is dosed.
Sarepta is a pioneer in the area of DMD with the only disease-modifying treatment out on the market approved by the US Food & Drug Administration.
Access to R&D
The deal, as well as having a massive financial impact, will provide Summit access to the research and development capabilities of the US firm.
DMD is caused by different mutations in the dystrophin gene that result in patients being unable to produce the protein, which is essential for maintaining healthy muscle function.
The AIM-listed group’s discovery is designed to increase the levels of another, similar, protein call utrophin.
This, it is hoped, will compensate from the lack dystrophin. The system is called utrophin modulation.
Summit chief executive Glyn Edwards said: "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline.
“We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
About DMD
Duchenne Muscular Dystrophy, or DMD, is one of the most common, fatal genetic disorders diagnosed in children around the world.
It predominantly affects boys and it results in the progressive wasting of muscles throughout the body.
The disease has an estimated incidence of 1 in 5,000 and a patient population in the developed world of around 50,000.
Patients typically don’t live beyond their late 20s.
Sarepta’s chief executive, Edward Kaye, said: "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
From the conference call
The deal provides another two years of financing at least, according to Edwards, who was speaking to analysts, investors and journalists on a conference call.
He told them: "We believe our existing cash and the US$40mln upfront payment and the anticipated US$22mln milestone payment for the first dosing of the last patients in our Phaseout DMD study will fund the company through December 31, 2018."
On future partnering, Edwards said: "Our intention for other territories will be to develop these ourselves but obviously we will keep other options open. In particular, our intention is to keep marketing rights for the USA."
He also noted: "For a new company, just getting going, it's actually easier to market in the US, which is a true single market as opposed to Europe."
dreamcatcher
- 11 Sep 2017 16:42
- 208 of 213
Summit Therapeutics Awarded BARDA Contract Worth Up To $62M To Support Development of Ridinilazole for CDI
GNW
Summit Therapeutics plc
('Summit Therapeutics', Summit', or the 'Company')
SUMMIT AWARDED BARDA CONTRACT WORTH UP TO $62 MILLION TO SUPPORT THE DEVELOPMENT OF RIDINILAZOLE FOR THE TREATMENT OF C. DIFFICILE INFECTION
Cambridge MA, Oxford, UK, 11 September 2017 - Summit Therapeutics (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection ('CDI'), today announces that the Biomedical Advanced Research and Development Authority ('BARDA'), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, has awarded Summit a contract worth up to $62 million. The funds will support the clinical and regulatory development of ridinilazole for the treatment of CDI, including Summit's planned Phase 3 development program.
Ridinilazole is a highly selective, novel class antibiotic aimed at both treating the initial infection and reducing recurrent disease, which is the key clinical issue in the treatment of CDI. In a Phase 2 proof of concept clinical trial conducted in North America, ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin, and achieved a substantial reduction in rates of recurrent disease.
The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
"CDI is a serious public health threat that is a significant burden on the US population, and BARDA has committed to the development of innovative treatments capable of addressing all aspects of this serious illness, including recurrent disease. BARDA's selection of ridinilazole for an award is testament to ridinilazole's promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease," commented Glyn Edwards, Chief Executive Officer of Summit."This non-dilutive funding award begins to deliver on our strategy of maximizing the value of ridinilazole for patients with CDI, Summit and our shareholders, and we look forward to initiating the Phase 3 clinical program of ridinilazole."
The BARDA contract provides for a cost-sharing arrangement under which BARDA would fund a specified portion of estimated costs for specified activities related to the continued clinical and regulatory development of ridinilazole for CDI. Under the terms of the contract, Summit is initially eligible to receive from BARDA $32 million to fund, in part, obtaining regulatory approval for and commencing enrollment and dosing into Summit's two planned Phase 3 clinical trials of ridinilazole. In addition, Summit is eligible for additional funding under the contract pursuant to three independent option work segments, which may be exercised by BARDA in its sole discretion upon the achievement of certain development and other milestones for ridinilazole. If the three option work segments are exercised in full, Summit would be eligible for an additional $30 million from BARDA. Activities in these three option work segments include the completion of enrollment and treatment in the two planned Phase 3 clinical trials and other activities related to the preparation for the potential submission of application for marketing approval for ridinilazole in the United States.
With this contract award, Summit remains on track to initiate two Phase 3 clinical trials of ridinilazole for CDI in the first half of 2018. The Company continues to explore various funding options for completion of its Phase 3 clinical development program, with these including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.
This project will be funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600002C.
Summit will file on Form 6-K with the US Securities and Exchange Commission ('SEC') additional information about the agreement with BARDA. A copy of the Form 6-K will be available to download, from the date of this press release, either from the Investors section of the Company's website at www.summitplc.com, or from the SEC website at www.sec.gov.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About BARDA
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, makes available medical countermeasures to address public health emergencies arising from natural and intentional threats through an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools. For more information about BARDA, visit www.phe.gov/about/BARDA/Pages/default.aspx.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with over one million estimated cases of CDI each year in the United States and Europe. There are an estimated 29,000 death per year from CDI in the United States alone. The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
CDI is a bacterial infection of the colon that produces toxins that cause inflammation and severe diarrhea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.
About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response ('SCR') rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. The Phase 2 trial was conducted in North America with the majority of sites located in the United States. Ridinilazole has received Qualified Infectious Disease Product ('QIDP') designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit Therapeutics is a biopharmaceutical company with operations in the United States and United Kingdom and is focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.Summitplc.com and Summit can be followed on Twitter (@Summitplc).
dreamcatcher
- 21 Dec 2017 15:46
- 209 of 213
Summit Enters Licence and Commercialisation Agreement with Eurofarma for Latin American Rights to Ridinilazole
GNW
Summit Therapeutics plc
("Summit" or the "Company")
SUMMIT ENTERS INTO LICENCE AND COMMERCIALISATION AGREEMENT WITH EUROFARMA FOR LATIN AMERICAN RIGHTS TO RIDINILAZOLE, SUMMIT'S PRECISION ANTIBIOTIC IN DEVELOPMENT FOR THE TREATMENT OF CDI
Summit to receive $2.5 million upfront payment
Up to $25 million in development, regulatory, pricing and initial sales milestones
Summit retains commercial rights to ridinilazole in rest of the world
Oxford, UK, 21 December 2017 - Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection ('CDI'), announces that it has entered into an exclusive licence and commercialisation agreement granting Eurofarma Laboratórios SA ('Eurofarma') rights in Latin America (the 'Licensed Territory') to Summit's precision antibiotic ridinilazole in development for the treatment of CDI. Summit retains commercialisation rights in all other countries.
Ridinilazole is a targeted antibiotic that has the potential as a frontline therapy to treat initial infection and preserve patients' microbiomes to reduce the rate of recurrent CDI. In a Phase 2 proof of concept trial in CDI patients, ridinilazole demonstrated statistical superiority in sustained clinical response ('SCR') rates compared to the standard of care, vancomycin. Ridinilazole is expected to enter Phase 3 clinical trials in the first half of 2018.
"Eurofarma's established infrastructure and expertise in Latin America are ideally placed to commercialise our novel antibiotic, ridinilazole,"commented Glyn Edwards, Chief Executive Officer of Summit. "This agreement, combined with the recent contract award of up to $62 million from the US Government agency BARDA, will further support the Phase 3 clinical programme and regulatory development of ridinilazole. These partnerships endorse the potential of ridinilazole in the treatment of CDI, and move us a step closer to bringing this antibiotic to patients."
Eurofarma is a multinational pharmaceutical company with headquarters in Brazil and operations in over 20 countries in South and Central America, the Caribbean and Africa. Eurofarma has a broad portfolio of products across multiple therapeutic areas including a focus in infectious diseases where it markets a number of antibiotics.
"CDI is a serious global healthcare threat including in Latin America," added Martha Penna, P&D Vice-president of Eurofarma. "Through our interest in bringing innovative products to the region, we were impressed by the efficacy data from the ridinilazole Phase 2 programme and the differentiated profile of the drug. We believe it has the potential to address a major unmet need in CDI, and we look forward to working with Summit to bring ridinilazole to market for the benefit of patients."
Under the terms of the licence and commercialisation agreement, Summit will receive an upfront payment of $2.5 million, and is entitled to receive a further $3.75 million in development milestones upon the achievement of staged patient enrolment targets in the planned Phase 3 clinical trials of ridinilazole. Summit is eligible to receive up to an additional $21.4 million through other development milestones, commercial milestones, and one-time sales milestones based on cumulative net sales up to $100 million in the Licensed Territory. Further, the agreement provides for product supply transfer payments expected to provide a return equivalent to a high single digit to low double-digit percentage of net sales. For each incremental $100 million in cumulative net sales achieved, Summit is entitled to a further milestone payment which, when combined with the aforementioned product supply transfer payments, is expected to provide a return equivalent to a mid- to high-teens percentage of net sales.
Eurofarma will be responsible for obtaining regulatory approval for ridinilazole in the Licensed Territory. Summit retains full responsibility for the clinical development of ridinilazole in all countries, and is responsible for obtaining regulatory approvals outside of the Eurofarma licensed territories.
A Form 6-K will be filed with the US Securities and Exchange Commission ('SEC') that contains additional information about the terms of the licence and commercialisation agreement with Eurofarma. A copy of this Form 6-K will be available to download either from the Investors section of the Company website at www.summitplc.com or from the SEC website at www.sec.gov.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About Ridinilazole
Ridinilazole is a small molecule precision antibiotic that Summit is developing for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a targeted spectrum of activity that combined a potent bactericidal effect against all clinical isolates of C. difficile tested with minimal impact on other bacteria that are typically found in the gut microbiome. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response ('SCR') rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole, an orally administered small molecule, has received Qualified Infectious Disease Product ('QIDP') designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
About the Eurofarma Group
As the first 100% Brazilian-owned multinational pharmaceutical company, Eurofarma has been in existence for 45 years, has 6,500 employees, and has operations in 20 Latin American countries. With 12 manufacturing plants in the region, the company has more than 280 products in its portfolio. In 2016, it produced more than 290 million units and reached revenues of R$3.3 billion, 15.7% higher than the previous year. The Group invests approximately 5.5% of its net sales in Research & Development and maintains a pipeline of more than 175 projects.
About Eurofarma Brazil
Considered one of the best companies to work for, Eurofarma Brazil is also considered the most sustainable pharmaceutical company in the country based on an analysis by the Exame Sustainability Guide. With operations in all main pharmaceutical segments including Medical Prescriptions, Generics, Hospital, Oncology, Veterinary, and Bids and Services to Third Parties, Eurofarma has the largest medical advertising salesforce in Brazil with more than 2,000 representatives that together perform 450,000 medical contacts per month. The company has the 4th largest pharmacy system in the country and has a portfolio of medicines that is the 2nd largest by prescription volume.
hangon
- 27 Jun 2018 14:27
- 210 of 213
dreamcatcher, I guess this is one of yours - pity today's fall from grace - but these things happen in Biotech. Today, sp 48p on News of Trial halting.... that's a massive 78% fall from grace...but I wonder that it ever was worth the higher figure; since the number of patients is relatively small and not all can afford £ots of money to pay-back the Research Costs.
What now, I wonder . . . what's their Cash position and are there any Liabilities, such as Loans outstanding...?
EDIT(12Dec2018)-sp 19p after a serious fall (again). but PE ratio -1.2 DYOR.
dreamcatcher
- 27 Jun 2018 15:56
- 211 of 213
No, not held this year.
bennion
- 01 Jul 2018 15:55
- 212 of 213
Another of Jim Mellons favourites, Regent Pacific, which took over Plethora Solutions, and now listed in Hong Kong (ticker 575) is rolling out it's premature ejaculation spray Fortacin right across Europe this year through distributor Recordati.
There has been little PR about this...but according to Recordati they are very excited about Fortacins sales prospects.
And don't forget, Fortacin comes from the stable of Prof. Mike Whiley, and has full EU approval.
A good time to reinvest for some likely big gains.............maybe a better bet than Summit............
bennion
- 01 Jul 2018 15:56
- 213 of 213
P.s. To previous posts, Regent Pacific can be held in an ISA, SIPP, or general trading account.......try iii.