Acurx Eyes Single-Trial FDA Approval for Ibezapolstat

The agency’s guidance offers a potential shortcut for the Staten Island-based company, which is developing ibezapolstat as a targeted therapy for Clostridioides difficile. Officials confirmed that the final determination will rest on the consistency and clinical relevance of findings from the upcoming IBZ-ASPIRE trial, when combined with results from the ongoing IBZ-PATHFINDER study. If the data meets these benchmarks, the company could secure approval for two distinct clinical indications simultaneously.

While the FDA remains open to this accelerated path, it clarified that a second trial would be required if the primary study fails to demonstrate the necessary efficacy. Acurx plans to move forward with the international IBZ-ASPIRE study, a non-inferiority trial involving approximately 550 patients randomized against the current standard-of-care, vancomycin. Executive Chairman Robert J. DeLuccia noted that the company is now focused on securing the funding required to initiate this next phase of development as it works to address the significant public health burden of recurrent C. difficile infections.