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Summit Therapeutics PLC (NASDAQ:SMMT, LON:SUMM) is to proceed with the planned extension phase of PhaseOut DMD, subject to regulatory approval.
PhaseOut DMD is a Phase 2 clinical trial evaluating the utrophin modulator ezutromid as a treatment for Duchenne muscular dystrophy (DMD).
The decision to press on with the trial follows an interim review of the safety and tolerability data from the ongoing trial by an independent Data Monitoring Committee and its support of Summit’s plans to extend the clinical trial.
Summit has now applied for regulatory approval to extend PhaseOut DMD from the UK Medicines and Healthcare products Regulatory Agency and Ethics Committee, and has submitted the necessary regulatory updates to the US Food and Drug Administration.
The submissions should pave the way for patients participating in PhaseOut DMD onto an open-label extension phase – where participants know what treatment they are getting and there is no need for one group of participants to take a placebo – at the end of the initial 48-week dosing period.
The extension phase will be used to gather long term safety and efficacy data.
“The proposed extension phase will allow us to gather important long-term safety and efficacy data of ezutromid in patients with DMD that we believe will comprise part of a data package necessary for future applications for regulatory approval of ezutromid,” said Ralf Rosskamp, MD, chief medical officer of Summit.
“While the PhaseOut DMD trial continues with the aim of establishing proof of concept for ezutromid, we are pleased to see that the DMC supports the trial’s extension based on their review of the safety and tolerability data to date, which includes data from patients dosed over longer periods of time than have previously been tested,” he added.
Shares in Summit rose 3.7% on the news and have more than doubled over the last year.
Story by ProactiveInvestors