Summit Therapeutics plc announced that it will discontinue development of ezutromid based on Phase 2 trial results that failed to meet primary or secondary endpoints after 48 weeks of treatment.
Ezutromid was under study as a possible treatment for patients suffering from Duchenne muscular dystrophy (DMD). Company stock plummeted nearly 80 percent following the announcement.
Summit announced that now it will turn its attention to the development of its pipeline of new mechanism antibiotics, the lead product of which, ridinilazole, is expected to enter Phase 3 clinical trials for the treatment of C. difficile infection in next year’s first quarter.
“We recognize that this decision will be disappointing for the Duchenne community, but the data from PhaseOut DMD were clear that ezutromid, while well-tolerated, did not provide a benefit to patients with DMD,” Glyn Edwards, chief executive officer of Summit, said following the announcement to discontinue development of the drug.
“These results are not what we had hoped for, and certainly not what we had expected based on the encouraging interim results from PhaseOut DMD. But, they provide a clear answer to the important scientific question of ezutromid’s effect in DMD,” Edwards added. “The results provided no evidence that ezutromid is having a meaningful effect on slowing DMD progression.”
Summit currently is working with the clinical trial investigators in PhaseOut DMD to bring the trial and associated extension phase to a conclusion. The company plans to also explore ways that information gathered as part of PhaseOut DMD can be made available to support other research activities in DMD for the benefit of the DMD community.
(Sources: Summit Therapeutics plc; Market Watch)
Filed Under: Drug Discovery
