Summit Receives Regulatory Approval to Initiate a Modified Diet Clinical Trial of SMT C1100 in DMD Patients

Accessibility: Skip TopNav

December 11, 2014 02:00 ET

Summit Therapeutics plc

Summit Therapeutics plc

Summit Corporation plc

('Summit' or 'the Company')

SUMMIT RECEIVES REGULATORY APPROVAL TO INITIATE A MODIFIED DIET CLINICAL TRIAL OF SMT C1100 IN DMD PATIENTS

Oxford, UK, 11 December 2014 - Summit (AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy ('DMD') and C. difficile infection ('CDI'), announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency and the Ethics Review Committee to initiate a Phase 1b modified diet trial of SMT C1100.  SMT C1100 is an oral small molecule utrophin modulator in development for the potential treatment of all patients with DMD, regardless of the underlying dystrophin fault causing the disease.

This new trial aims to increase the plasma levels of SMT C1100 by providing patients with specific dietary guidance intended to improve drug absorption.  The trial will also evaluate the potential impact that SMT C1100 is having on enzyme markers of muscle health.  Top-line data from the Phase 1b modified diet trial are expected to be reported in mid-2015.

"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," commented Glyn Edwards, Chief Executive Officer.  "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."

He added, "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."

About the Phase 1b Modified Diet Trial

The Phase 1b modified diet trial is a placebo-controlled study that will enrol a total of 12 patients with DMD between the ages of 5 and 13.  The patients will be divided into three cohorts of four patients each, and the trial will include three randomized 14-day treatment periods during which each patient will receive two different doses of SMT C1100 and placebo.  There will be a 14-day wash-out period between each of the three treatment periods.

The trial aims to demonstrate an increase in plasma levels of SMT C1100 compared to those observed in the open label Phase 1b trial that was completed earlier in 2014 with patients to follow specific dietary guidance that recommends balanced proportions of fat, protein and carbohydrates.  The trial will also evaluate any changes in enzyme markers that are related to muscle health, and further evaluate the safety and tolerability of SMT C1100.  The Phase 1b modified diet trial will be conducted at four NHS hospitals located in the UK.

If this trial is successful, it will be followed by a Phase 2 open label trial that will seek to generate longer-term efficacy and safety data on SMT C1100.  It is expected that patients participating in the Phase 1b modified diet trial will be eligible to join the Phase 2 open label trial.

About DMD and Utrophin Modulation

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 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.

Summit is a drug discovery and development company targeting two high-value areas of unmet medical need:  the muscle wasting disease Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

For more information, please contact:

Forward Looking Statements

This announcement, and the presentations referred to in it, 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.