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

Summit Considering Potential US Registered Publ...

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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.

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Summit Corporation PLC : Third Quarter Results ...
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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).

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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.

Summit Announces First Patients Dosed in Phase ...
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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.

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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.

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.

Watch: Summit plc - Master Investor 2015

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Summit Therapeutics Granted Key Patent for Nove...
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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."

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SUMMIT THERAPEUTICS TO PRESENT NEW PRECLINICAL DATA ON UTROPHIN MODULATOR PROGRAMME AT PPMD CONNECT CONFERENCE

Summit Therapeutics Granted Key Patent by Europ...
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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.

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Summit Therapeutics Receives Fast Track Designa...
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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.

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Summit Therapeutics Publishes Preclinical Data ...
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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).

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AGM Statement

Summit Therapeutics Announces Phase 1b Modified...
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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).

Summit Therapeutics Reports Financial Results f...
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Summit Therapeutics plc
('Summit' or the 'Company')

SUMMIT THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THE SECOND QUARTER ENDED 31 JULY 2015 AND OPERATIONAL PROGRESS

Oxford, UK, 27 August 2015 - Summit Therapeutics plc (AIM: SUMM, NASDAQ: SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection ('CDI'), today reports its financial results for the second quarter and half-year ended 31 July 2015.

Mr Glyn Edwards, Chief Executive Officer of Summit commented: "We have made very substantial progress with our utrophin modulator programme to treat boys with DMD with the recent announcement that our lead candidate, SMT C1100, achieved its primary objective in a Phase 1b clinical trial, allowing us to advance this molecule into a Phase 2 open-label trial that is expected to start by the end of this year. We further strengthened this programme with the publication of data on a second-generation utrophin modulator demonstrating its disease-modifying potential in animal models of this devastating disease. Importantly, we also received Fast Track designation from the US FDA for SMT19969 in CDI, highlighting the promise of our novel antibiotic treatment with the potential to address disease recurrence, the key clinical issue of CDI. With top-line data from our ongoing Phase 2 proof of concept trial in CDI expected to report in the fourth quarter of 2015, we continue to be excited about progress in both of our clinical programmes."

RECENT OPERATIONAL HIGHLIGHTS

Utrophin Modulation Programme for DMD:

SMT C1100 Highlights

Phase 1b modified diet clinical trial achieved primary objective in DMD
Plasma absorption of SMT C1100 observed at a level suitable for further development
SMT C1100 to progress into Phase 2 open-label clinical trial planned to commence in Q4 2015
Key composition of matter patent granted by European Patent Office for SMT C1100
Utrophin Modulation Pipeline

Positive preclinical data published on second-generation utrophin modulator showing increase in utrophin expression along entire length of muscle fibre, reduction in disease pathology and improvement in muscle function
CDI Programme:

SMT19969 Highlights

Phase 2 proof of concept clinical trial of novel antibiotic SMT19969 against vancomycin on-going with top-line data expected to be reported in Q4 2015
SMT19969 granted Fast Track status by the US Food and Drug Administration
Grant of key patent in the US protecting the use of SMT19969 in the treatment of CDI
FINANCIAL HIGHLIGHTS

Cash and cash equivalents at 31 July 2015 of £26.4 million compared to £11.3 million at 31 January 2015
Loss for the three months ended 31 July 2015 of £4.0 million compared to a loss of £3.3 million for the three months ended 31 July 2014
Initial Public Offering of American Depositary Shares in the US completed in March 2015 raising gross proceeds of $39.3 million

summit-ceo-data-results-could-be-transformational-for-us

summit-therapeutics-successfully-completes-patient-enrolment

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Proactive investor - Summit Therapeutics PLC (LON:SUMM), up 10% to 140.5p. Said this morning that its treatment for Duchenne muscular dystrophy has received fast-track designation from the US FDA.

Sarepta Therapeutics and Summit Enter into Excl...
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Sarepta Therapeutics and Summit Enter into Exclusive License and Collaboration Agreement for European Rights to Summit's Utrophin Modulator Pipeline for the Treatment of Duchenne Muscular Dystrophy
Sarepta and Summit collaborate to advance the development of novel therapies for patients with Duchenne muscular dystrophy
Summit receives $40 million upfront, with potential future ezutromid-related milestone payments totalling up to $522 million plus royalties
Sarepta and Summit to share research and development costs
Sarepta also receives option for Latin American rights 
Cambridge, MA, and Oxford, UK, 4 October 2016 - Sarepta Therapeutics (NASDAQ: SRPT) and Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that they have entered into an exclusive license and collaboration agreement granting Sarepta rights in Europe, as well as in Turkey and the Commonwealth of Independent States ('the licensed territory'), to Summit's utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of Duchenne muscular dystrophy ('DMD'). As part of the agreement, Sarepta also obtains an option to license Latin American rights to Summit's utrophin modulator pipeline. Summit retains commercialization rights in all other countries.
Utrophin modulation is a potential disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, regardless of their underlying dystrophin gene mutation. Ezutromid is currently in a Phase 2 proof of concept trial called PhaseOut DMD.
"This partnership with Summit Therapeutics furthers our commitment to invest in innovative approaches to treating Duchenne and supports our common goal of improving the lives of patients with DMD," said Edward Kaye, M.D., Sarepta's Chief Executive Officer. "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
"Sarepta Therapeutics has paved the way in the development of disease-modifying therapies for DMD with the first FDA-approved drug in this disease area, making them a strong strategic partner to support our utrophin modulator pipeline," commented Glyn Edwards, Chief Executive Officer of Summit. "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline. We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
Under the terms of the agreement, Summit will receive an upfront fee of $40 million. In addition, Summit will be eligible for future ezutromid related development, regulatory and sales milestone payments totalling up to $522 million, including a $22 million milestone upon the first dosing of the last patient in Summit's PhaseOut DMD trial, and escalating royalties ranging from a low to high teens percentage of net sales in the licensed territory. Summit will also be eligible to receive development and regulatory milestones related to its next-generation utrophin modulators. Sarepta and Summit will share specified utrophin modulator-related research and development costs at a 45%/55% split, respectively, beginning in 2018. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties.
Sarepta and Summit will host an update call for the Duchenne community on Monday, October 10 at 12:00 EDT. Details of the call can be accessed by visiting http://www.parentprojectmd.org/communitycall. 
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to treat all patients with DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company's lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration ('FDA') and the European Medicines Agency have granted orphan drug status to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation and Rare Pediatric Disease designation by the FDA.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
About Sarepta
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.
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Summit Therapeutics shares shoot up 90% after it inks $522mln Sarepta deal
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16:15 04 Oct 2016
Summit has inked a deal that could potentially be worth more than half a billion dollars.

The company is developing what it hopes is a breakthrough for a hard to treat disease that affects boys.
Shares in Summit Therapeutics (LON:SUMM) shot up 90% after it confirmed it had signed a licensing deal with the US biotech Sarepta Therapeutics (NASDAQ:SRPT) worth up to US$522mln.
The pair will collaborate on Summit’s potentially breakthrough treatment for Duchenne muscular dystrophy (DMD), a muscle wasting disease that affects boys.
The UK drug developer gets an immediate US$40mln and US$22mln when the last patient in the company’s phase II trial is dosed.
Sarepta is a pioneer in the area of DMD with the only disease-modifying treatment out on the market approved by the US Food & Drug Administration.
Access to R&D
The deal, as well as having a massive financial impact, will provide Summit access to the research and development capabilities of the US firm.
DMD is caused by different mutations in the dystrophin gene that result in patients being unable to produce the protein, which is essential for maintaining healthy muscle function. 
The AIM-listed group’s discovery is designed to increase the levels of another, similar, protein call utrophin.
This, it is hoped, will compensate from the lack dystrophin. The system is called utrophin modulation.
Summit chief executive Glyn Edwards said: "This agreement provides us with access to Sarepta's development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline.
“We look forward to this partnership and working together to bring great advances to patients and families living with DMD."
About DMD
Duchenne Muscular Dystrophy, or DMD, is one of the most common, fatal genetic disorders diagnosed in children around the world. 
It predominantly affects boys and it results in the progressive wasting of muscles throughout the body. 
The disease has an estimated incidence of 1 in 5,000 and a patient population in the developed world of around 50,000. 
Patients typically don’t live beyond their late 20s.
Sarepta’s chief executive, Edward Kaye, said: "Summit's utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy."
From the conference call 
The deal provides another two years of financing at least, according to Edwards, who was speaking to analysts, investors and journalists on a conference call.
He told them: "We believe our existing cash and the US$40mln upfront payment and the anticipated US$22mln milestone payment for the first dosing of the last patients in our Phaseout DMD study will fund the company through December 31, 2018."
On future partnering, Edwards said: "Our intention for other territories will be to develop  these ourselves but obviously we will keep other options open. In particular, our intention is to keep marketing rights for the USA."
He also noted: "For a new company, just getting going, it's actually easier to market in the US, which is a true single market as opposed to Europe."