Summit Announces PhaseOut DMD Did Not Meet Primary Endpoint
Ezutromid Development to be Discontinued
Summit to Focus on Advancing its Pipeline of New Mechanism Antibiotics
Conference Call Scheduled for 8:00am EDT / 1:00pm BST
Oxford, UK, and Cambridge, MA, US, 27 June 2018 - Summit Therapeutics plc (AIM:SUMM, NASDAQ:SMMT) today announces PhaseOut DMD has not met its primary or secondary endpoints after 48 weeks of treatment of ezutromid in patients with Duchenne muscular dystrophy ('DMD'). PhaseOut DMD was a multi-centre, open-label Phase 2 clinical trial of the utrophin modulator, ezutromid.
Based on this outcome, the Company is discontinuing its development of ezutromid and as a result, will be implementing cost reduction measures. Summit will now focus its operations on the development of its pipeline of new mechanism antibiotics. The Company's lead product candidate, ridinilazole, is expected to enter Phase 3 clinical trials for the treatment of C. difficile infection in Q1 2019.
"These data come as a great disappointment to us and to all those living with DMD," said Glyn Edwards, Chief Executive Officer of Summit. "While we believe utrophin modulation could still have a place in the treatment of DMD, it is clear that ezutromid is not providing a benefit for patients. We therefore feel that our resources are better focussed on the development of our promising pipeline of new mechanism antibiotics.
"We sincerely thank the patients, families and clinical trial sites involved in all of the ezutromid clinical trials for their commitment to advancing research in DMD. We hope that the information we have gathered can ultimately be used to benefit ongoing research in DMD."
Summit is currently 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.
About PhaseOut DMD
A total of 40 boys with DMD were enrolled in PhaseOut DMD, with 38 completing the 48-week clinical trial. Ezutromid was dosed twice a day at either 1000 mg (F6 formulation) or 2500 mg (F3 formulation). The primary endpoint was the change from baseline in magnetic resonance parameters related to the leg muscles. Biopsy measures evaluating utrophin and muscle damage were included as secondary endpoints, with patients having two biopsies: one at baseline and their second after either 24 weeks or 48 weeks of ezutromid treatment. Exploratory endpoints included the six-minute walk distance, the North Star Ambulatory Assessment and patient reported outcomes. While statistical decreases in developmental myosin and magnetic resonance T2 measures were seen after 24 weeks of treatment, these effects were not seen after 48 weeks of treatment. Ezutromid was generally well-tolerated in the trial.