The biopharmaceutical company said Wednesday that under the Phase 2 clinical ezutromid treatment study, it will analyse several thousand muscle fibres of patients with DMD, to remove human bias.
PhaseOut DMD is a 48-week open-label Phase 2 clinical trial that has enrolled 40 patients at sites in the
The company said it intends to publish the study results in the third quarter of 2018, having previously planned to finish studies in the first quarter of 2018.
"Since DMD is a muscle-wasting disorder, it is critical for us to have high quality data from objective muscle health measurements as we assess ezutromid's activity. As the collection of muscle biopsy and MRS measurements are a major intervention for patients in clinical trials, it means it is crucial this is done in a robust and reliable way," said Summit Therapeutics Chief Medical Officer and President of Research and Development David Roblin.
"Our data collection and analysis methods used in PhaseOut DMD helped yield a high-quality dataset from all evaluable boys in the trial after 24-weeks of treatment. We are grateful to all the boys in the trial and excited about the interim findings that showed compelling signs of ezutromid activity," Roblin added.
At the end of January, the company said that the treatment led to a 23% reduction in mean developmental myosin, in muscle biopsies at 24 weeks compared to the baseline of around 9% to 11%. Development myosin is a biomarker of muscle damage. Out off 22 patients, 14 saw a fall in myosin, with five showing a reduction over 40%.
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