Acurx’s ibezapostat shows favorable effect in Phase 2b CDI trial

Acurx (ACXP) Pharmaceuticals announced the presentation of a scientific poster at the Infectious Diseases Society of America IDWeek 2024 Conference held October 16-19 in Los Angeles. The data presented indicate a favorable gut bile acid profile which may contribute to ibezapostat’s beneficial anti-recurrence effect in patients with C. difficile Infection – CDI -. Ibezapolstat treatment of patients with CDI is associated with the restoration of beneficial bacterial classes in the gut. Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of CDI. Acurx is preparing to submit requests for regulatory guidance to initiate clinical trials in the EU to be followed by the UK, Japan and Canada. Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA. In the Phase 2b clinical trial, ibezapolstat had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin. Also, 5 of 5 ibezapolstat patients who were followed for 3 months after end of treatment experienced no recurrence. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a NDA for marketing approval.