Acurx announces results of Phase 2 ibezapolstat trial in C. difficile Infection

Acurx Pharmaceuticals announced results from its research with ibezapolstat in collaboration with Leiden University Medical Center. Ibezapolstat is the company’s lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection, or CDI. Results feature high-resolution elucidation of interaction of ibezapolstat with its molecular target . Mechanistic findings explain ibezapolstat’s properties of lacking cross resistance with other antibiotics and not fostering the emergence of Enterococcus, including vancomycin-resistant strains, a unique differentiation among anti-CDI antibiotics. Acurx previously had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for treatment of CDI. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program and the complete development plan for filing of an NDA for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of CDI. Acurx is also now preparing to submit requests for regulatory guidance to initiate clinical trials in the EU, the U.K., Japan and Canada. Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement with FDA on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. The research outcome is intended to accelerate lead product candidate selection for Acurx’s pre-clinical program for other WHO, CDC and FDA high-priority, multi-drug resistant Gram-positive pathogens where new classes of antibiotics are needed.