Ibezapolstat

Acurx Pharmaceuticals received positive EMA feedback for ibezapolstat's Phase 3 program for CDI treatment, supporting its advancement. With FDA and EMA guidance, Acurx plans international Phase 3 trials. Ibezapolstat, a novel antibiotic, shows promise in treating C. difficile with minimal microbiome disruption.

Acurx Pharmaceuticals received positive feedback from the EMA for its ibezapolstat Phase 3 program for CDI treatment, supporting its advancement. With FDA and EMA guidance, Acurx is set to start international Phase 3 trials. Ibezapolstat has FDA QIDP and Fast-Track Designation, aiming to treat C. difficile infections effectively.

Acurx Pharmaceuticals received positive feedback from the EMA for its ibezapolstat Phase 3 program, supporting its advancement for CDI treatment. With guidance from EMA and FDA, Acurx plans international Phase 3 trials and seeks regulatory advice for trials in Japan, Canada, and the UK. Ibezapolstat, with FDA QIDP and Fast-Track Designation, aims to treat C. difficile infections, showing promise in Phase 2 trials with a 96% Clinical Cure rate.

Acurx Pharmaceuticals received positive EMA feedback for ibezapolstat's Phase 3 program for CDI treatment, supporting its advancement. With FDA and EMA guidance, Acurx plans international Phase 3 trials and seeks regulatory advice for trials in Japan, Canada, and the UK. Ibezapolstat, with FDA QIDP and Fast-Track Designation, shows promise in treating CDI with a 96% clinical cure rate in Phase 2 trials.

Acurx Pharmaceuticals received positive FDA feedback on CMC plan for Phase 3 clinical program, initiated EMA Scientific Advice procedure, and is discussing pediatric development plans for ibezapolstat in C. difficile Infection. Phase 3 international trial planning advances using AI, and Acurx prepares to request regulatory guidance for clinical trials in Japan, Canada, and the UK. Ibezapolstat has FDA QIDP and Fast-Track Designation, and Acurx received EMA SME designation.

Acurx Pharmaceuticals updates on Phase 3 readiness for ibezapolstat in C. difficile infection, following favorable FDA and EMA communications. The company anticipates a clear international roadmap for Phase 3 trials and future NDA submission.

DelveInsight's 'Clostridium Difficile Infections Pipeline Insight, 2024' report details 20+ companies developing 22+ therapies, including Vedanta Biosciences' VE303 in Phase 3 and Ferring Pharmaceuticals' REBYOTA® approved by FDA in 2022. The report covers clinical trials, mechanisms of action, and route of administration for emerging treatments.

Dr. Kevin Garey presents phase 2 clinical trial results of ibezapolstat for Clostridioides difficile infection at the Peggy Lillis Foundation symposium, highlighting its favorable microbiome effects and efficacy.