Pilot trial of ibezapolstat in multiply recurrent C. difficile infection
Acurx initiated start-up activities for a clinical trial of ibezapolstat in multiply recurrent C. difficile infection.
First patient expected to enroll next quarter; program begins with a 20-patient open-label pilot in patients with at least 3 episodes in 12 months.
Positive pilot results would inform an active-controlled Phase 3 registration trial in rCDI; approval path targeted under FDA’s Limited Population Pathway.
Company also plans an international Phase 3 registration program in acute CDI, citing consistent feedback from the FDA and EMA.
ACXP•
