Acurx’s ibezapolstat receives positive EMA opinion in C. difficile infection

Acurx (ACXP) announced receipt of a favorable opinion from the Paediatric Committee of the European Medicines Agency, or EMA, on Acurx’s Pediatric Investigation Plan for ibezapolstat use in children with C. difficile infection, or CDI. C. difficile is the most important infectious cause of antibiotic-associated diarrhea worldwide and a leading cause of healthcare-associated infection in the U.S. The incidence of CDI in children has increased, with 20,000 cases now reported annually. Receipt of this positive opinion caps off the EMA’s requirement to have the PIP agreed to by the initiation of ibezapolstat Phase 3 clinical trials in the EU. Acurx previously announced that both the EMA and the FDA are aligned with its clinical trial program in the adult population along with clearly defined requirements for the regulatory pathway to an EU MAA and a U.S. NDA. In addition to receiving this positive EMA opinion, Acurx will proceed with its integrated PIP submission to the FDA. Acurx is positioned to begin international Phase 3 clinical trials and has previously been granted FDA QIDP and Fast-Track Designation and has received Small and Medium-sized Enterprise designation by the EMA.