Acurx Receives Positive FDA Feedback on Ibezapolstat Phase 3 Development Program, FDA Signals Potential Single-Trial NDA Pathway

Acurx Pharmaceuticals has reported a positive outcome from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 development program for ibezapolstat, its investigational antibiotic for Clostridioides difficile infection (CDI). During the meeting, the FDA indicated it is open to discussing the possibility of a New Drug Application (NDA) based on a single Phase 3 trial, provided the overall clinical evidence and supporting data are sufficiently robust at the time of a future Pre-NDA meeting.

The FDA noted that acceptance of a single pivotal trial would depend on several factors, including the strength and consistency of efficacy results, the relevance of the findings to U.S. clinical practice, the quality of the safety database, and supportive evidence from earlier studies. The agency also acknowledged Acurx's planned study in recurrent CDI (rCDI), stating that positive results from this trial could strengthen a future NDA submission. If the required standards are not met, the FDA recommends conducting a second Phase 3 study in line with the agreement reached during the company's End-of-Phase 2 meeting in 2024.

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "We are very pleased with the guidance and support received from FDA for continued development of ibezapolstat toward a potential NDA." He further stated: "We're confident that if we successfully meet the IBZ-ASPIRE trial endpoints, approval for both treatment and reduction of recurrence is possible based on a single Phase 3 trial. The results from IBZ-PATHFINDER will be important data to support the indication for reduction of recurrence." 

Acurx's planned IBZ-ASPIRE Phase 3 trial will use a non-inferiority design, enrolling approximately 550 patients in the modified intent-to-treat population. Participants will be randomized equally to receive either ibezapolstat or the current standard treatment, vancomycin. The FDA agreed with the proposed study design and evaluation criteria, including the potential to support indications for both acute CDI treatment and reduction of disease recurrence.

If the trial successfully demonstrates that ibezapolstat is non-inferior to vancomycin in achieving clinical cure, additional analyses will assess whether it provides superior protection against CDI recurrence and improved clinical cure outcomes. The company's regulatory discussions mark another step toward advancing ibezapolstat as a potential new treatment option for patients with difficult-to-treat bacterial infections.