Acurx’s ibezapolstat shows positive results in CDI and Anthrax

Acurx Pharmaceuticals announced results from new analyses that extend data on the beneficial effects of ibezapolstat on the gut microbiome. The data show an increased proportion of Actinobacteriota and increased quantity of beneficial Bacillota leading to reversal of dysbiosis and contributing to the C. difficile Infection, or CDI, anti-recurrence effect of ibezapolstat. Additionally, ibezapolstat’s favorable pharmacokinetics properties were confirmed. Microbiological testing of certain ACX-375 DNA pol IIIC analogues demonstrated in vitro activity with MICs of 0.5-2mcg/mL against Anthrax, a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant B. anthracis. Acurx previously had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical 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 preparing to submit requests for regulatory guidance to initiate clinical trials in the EU, the UK, Japan and Canada.