PureTech-founded,Vedanta, enrollls 1st patient in RESTORATiVE303 sudy of VE303

Vedanta Biosciences announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study. VE303 is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection, rCDI. The RESTORATiVE303 trial is evaluating the efficacy and safety of VE303 in patients with rCDI and is intended to form the basis for a Biologics License Application BLA to be filed with the U.S. Food and Drug Administration. “Initiation of the RESTORATiVE303 study represents a key clinical milestone for the VE303 program. Building on the successes of earlier VE303 clinical studies, RESTORATiVE303 is the first pivotal Phase 3 study of a live biotherapeutic product for prevention of recurrent CDI, a potentially serious infection that affects up to 175,000 patients and results in approximately 20,000 deaths annually in the U.S.,” said Jeffrey Silber, M.D., Chief Medical Officer of Vedanta Biosciences. “Based on the efficacy and safety data we have generated to date for this program, we believe that an oral, rationally designed, defined consortium candidate has the potential to offer patients with rCDI an attractive alternative to undefined, donor-derived fecal approaches.” In April 2023, Vedanta published results from the Phase 2 CONSORTIUM trial, in which treatment with VE303 was associated with a 30.5% adjusted absolute risk reduction in the rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a CDI recurrence.