Ibezapolstat

Aug. 3, 2026: Acurx Pharmaceuticals (NASDAQ: ACXP) said FDA meeting minutes from a July 13, 2026 Type C meeting provided guidance on the Phase 3 and NDA path for ibezapolstat in Clostridioides difficile infection (CDI). FDA said it is open to discussing an NDA based on a single Phase 3 trial at a pre-NDA meeting, depending on the totality of evidence, including efficacy robustness, safety, Phase 2 data, and relevance to U.S. practice.

For the planned IBZ-ASPIRE Phase 3 trial, FDA agreed with the overall design: a non-inferiority study in about 550 modified intent-to-treat patients, randomized 1:1 to ibezapolstat or vancomycin. If non-inferiority is shown for clinical cure, further analyses would test superiority for recurrence reduction and for clinical cure. FDA agreed that, if successful, the trial could support indications for both acute treatment and reduction of recurrence of CDI. If IBZ-ASPIRE is not sufficient, FDA recommended a second trial consistent with the April 27, 2024 end-of-Phase 2 agreement.

Acurx also said successful results from the open-label IBZ-PATHFINDER Phase 2 trial in multiply recurrent CDI would support NDA filing; startup has begun, with enrollment expected in Q4 2026 / the next few months.