Core Insights - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to international Phase 3 clinical trials for treating C. difficile Infection (CDI) following positive regulatory guidance from the EMA and FDA [1][5][10] Regulatory Developments - The company received constructive feedback from the EMA during its Scientific Advice Procedure, confirming that the submitted clinical, non-clinical, and CMC information supports the advancement of the ibezapolstat Phase 3 program [1][5] - Acurx is preparing to submit requests for regulatory guidance to initiate clinical trials in the EU, UK, Japan, and Canada [2][5] Clinical Trial Design - The Phase 3 program will consist of two non-inferiority trials comparing ibezapolstat to vancomycin, with an estimated 450 subjects randomized in a 1:1 ratio [3][8] - The primary endpoint is Clinical Cure, assessed two days after a 10-day oral treatment [3][8] Phase 2 Clinical Trial Results - In the completed Phase 2 trials, ibezapolstat demonstrated a Clinical Cure rate of 96% (25 out of 26 patients) [7][8] - The Phase 2a segment showed 100% cure in 10 patients treated with ibezapolstat [6][8] - The Phase 2b segment reported that 14 out of 14 patients in the vancomycin control arm also achieved Clinical Cure [8] Mechanism of Action and Microbiome Impact - Ibezapolstat is a novel antibiotic that selectively targets Gram-positive bacteria, including C. difficile, while preserving healthy gut microbiota [10][14] - The treatment leads to favorable changes in bile acid metabolism, potentially reducing CDI recurrence [9][13] Market Context - CDI is a significant healthcare issue, with approximately 500,000 infections and 20,000 deaths annually in the U.S. [12] - The recurrence rate for current CDI treatments ranges from 20% to 40% [12]
Acurx Receives Positive Regulatory Guidance from EMA for Ibezapolstat Phase 3 Program for C. Difficile Infection (CDI)