Acurx: FDA accepts plan for ongoing Phase 2b ibezapolstat clinical trial

Acurx Pharmaceuticals announced that the FDA has accepted the company’s plan to have an Independent Data Monitoring Committee conduct an interim review of clinical outcome from the ongoing Ph2b clinical trial of patients with C. difficile Infection. The interim review will be conducted upon reaching enrollment of 36 patients in total. FDA’s acceptance was based on the company’s filing of a protocol amendment to its Investigational New Drug Application with FDA in January 2023. The company’s filing and intention for the IDMC to conduct an interim review of data was based on the observed blinded data to date from the ongoing Ph2b clinical trial at that time. Upon conducting the interim review, the IDMC will determine and recommend to the company whether the most appropriate course of action is to terminate the Ph2b clinical trial early due to success, as the company had done with the Ph2a clinical trial, or to continue patient enrollment. The company intends to report available data promptly after the IDMC conducts this interim review. The IDMC initial organizational meeting was conducted in March 2023 and it has completed all organizational matters required to ensure readiness for data review.