Vedanta Biosciences Continues Phase 3 Trial for VE303 to Prevent Recurrent C. difficile Infection
Vedanta Biosciences has announced that the independent Data Monitoring Committee (DMC) overseeing the Phase 3 RESTORATiVE303 trial of VE303 for preventing recurrent Clostridioides difficile infection (CDI) has recommended the study continue without modification. This decision follows a prespecified interim analysis that showed efficacy exceeding the futility threshold and no significant adverse events. The trial aims to evaluate VE303, an orally administered live biotherapeutic product, in patients at high risk for CDI recurrence. The study is being conducted across more than 150 sites in approximately 20 countries, with enrollment expected to complete in the second half of 2026. VE303 has shown promise in reducing CDI recurrence rates, having achieved a 30.5% adjusted absolute risk reduction in a previous Phase 2 study. 
