Ibezapolstat - (ASPIRE)

Sept. 29, 2026: Acurx Pharmaceuticals (NASDAQ: ACXP) announced first-patient-in in PATHFINDER, a Phase 2 multicenter, open-label, single-arm trial of ibezapolstat in multiply recurrent C. difficile infection (rCDI). The pilot study will enroll about 20 patients with at least three CDI episodes in the prior 12 months, with 14 days of treatment and assessments for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), CDI recurrence through Week 24, and Extended Clinical Cure through Week 24.

Acurx said PATHFINDER is intended to support a U.S. NDA and inform a planned active-controlled Phase 3 registration trial in rCDI. The company said it plans to seek FDA approval for treatment and prevention of rCDI under the Limited Population Pathway if PATHFINDER is successful.

Separately, the planned Phase 3 ASPIRE trial in acute CDI is a non-inferiority study versus vancomycin, with about 550 mITT patients randomized 1:1. FDA, in a July 13, 2026 Type C meeting, 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 data; successful PATHFINDER data could support that filing. Acurx also said it has FDA and EMA alignment on the Phase 3 program, but ASPIRE is subject to funding availability.