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Summit Corporation PLC (SUMM)
dreamcatcher
- 11 Sep 2012 21:55
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
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 -
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.
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:
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.
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.
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.
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.
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 -
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.
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.
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
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 -
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 -
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 -
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 -
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).
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).
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