Acurx Moves Forward With Phase 3 Trials For Ibezapolstat In C. difficil According To FDA And EMA Updates

Acurx Pharmaceuticals, Inc., is a biopharmaceutical company focused on developing innovative antibiotics for challenging bacterial infections. The firm has shared updates on the Phase 3 readiness of its lead candidate, ibezapolstat, for treating Clostridioides difficile infection (CDI). Following recent communications with the FDA and EMA, the company is set to advance ibezapolstat into international Phase 3 clinical trials.

Acurx previously reported a successful FDA End-of-Phase 2 meeting, during which key aspects of its Phase 3 trial plans were approved. These include agreements on trial design, patient population, endpoints, and the safety database necessary for a New Drug Application (NDA). Preparations are also ongoing to request regulatory guidance for clinical trials in the European Union, with subsequent submissions planned for the United Kingdom, Japan, and Canada.

Acurx's Executive Chairman, Bob DeLuccia, said in a statement, "We are very pleased with these latest favourable communications from both regulatory agencies and, in our opinion, are a testament to the strength of our clinical data to date, our robust regulatory submissions, and adherence to current regulatory guidance." 

He further added, "We anticipate, and are confident, that with final EMA advice for our ibezapolstat Phase 3 trials for adult patients with CDI and the pediatric development plans from both regulatory agencies, Acurx will have a clear international roadmap for the conduct of our Phase 3 program and, if successful, requirements for US NDA submission and EU Marketing Authorization."

The upcoming Phase 3 trials will involve two pivotal, non-inferiority studies. Approximately 450 participants will be included in the primary efficacy analysis using a Modified Intent-To-Treat (mITT) approach, aligning with EMA requirements. Participants will be randomized 1:1 to receive either ibezapolstat or vancomycin, the current standard of care. 

The study will assess ibezapolstat’s ability to achieve clinical cure of CDI two days after a 10-day treatment and its potential to reduce recurrence rates. If ibezapolstat demonstrates non-inferiority to vancomycin, additional analyses will evaluate whether it shows superiority. These advancements mark a significant step in Acurx's mission to address the urgent need for new antibiotics to combat drug-resistant infections.