FDA Offers Guidance for Ibezapolstat Phase 3 Trial in C. difficile Treatment

Acurx Pharmaceuticals received regulatory guidance from the FDA for its ibezapolstat Phase 3 clinical program, targeting C. difficile infection (CDI). The FDA indicated openness to a single Phase 3 trial design that could support both treatment and recurrence reduction for CDI. This guidance is significant as CDI is a common healthcare-associated infection with current antibiotic recurrence rates ranging from 20% to 40%, highlighting the need for improved therapies.