Seres Therapeutics initiates SER-287 Phase 2B ECO-RESET clinical study
Seres Therapeutics announced that it has enrolled the first patient in its Phase 2B trial, ECO-RESET, evaluating microbiome development candidate SER-287 in patients with active mild-to-moderate ulcerative colitis. Seres has received $40M in milestone payments associated with this study start from Nestle Health Science. The SER-287 Phase 2B ECO-RESET study has been designed as a pivotal trial. The company recently obtained feedback from the FDA indicating that results from this study, in conjunction with data from a second pivotal study, could enable a SER-287 Biologics License Application. The Phase 2B study is a three-arm placebo-controlled trial of approximately 200 patients with active mild-to-moderate ulcerative colitis. Two groups of patients will receive different doses of SER-287, both following pretreatment with a short course of oral vancomycin. A third study arm will receive placebo. The study's primary endpoint will evaluate clinical remission measured after 10 weeks of SER-287 administration. Endoscopic improvement will be measured as a secondary efficacy measure.