http://www.summitplc.com/
Summit is an Oxford, UK based drug discovery company developing novel drug candidates to treat areas of high unmet medical need. Our strategy has evolved to focus on the development of two high-value clinical-stage programmes that target the fatal genetic disease Duchenne Muscular Dystrophy (DMD) and infections caused by the superbug C. difficile

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.

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.

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.

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Some large volume for the last couple days as the share price is moving higher

up to 10.25p today, the volume has played a good part on the rise

Summit on BBC Breakfast 14 March 2014...

Some good early morning buys and the shares spiked, it has now settled

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.

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LISTEN:
Summit Corporation - Phase 1b clinical trial in DMD patients

Click here to listne

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...

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).

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SUMMIT APPOINTS ERIK OSTROWSKI AS CHIEF FINANCIAL OFFICER

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.

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consolidation of the shares @20/1

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.

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.

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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.

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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.

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:

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.

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.