Summit Announces First Patients Dosed in Phase 1b Modified Diet Clinical Trial of SMT C1100 for DMD

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February 20, 2015 02:01 ET

Summit Therapeutics plc

Summit Therapeutics plc

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.

About Summit Therapeutics

Summit is a 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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Forward Looking Statements

This announcement contains "forward-looking statements", including, but not limited to, statements about the discovery, development and commercialisation of programme assets. These forward-looking statements are statements based on the Company's current intentions, beliefs and expectations, which include, among other things, the Company's results of operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information.  Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to retain and recruit key personnel.  The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.