Acurx Pharmaceuticals Says First Patient Enrolled In New PATHFINDER Clinical Trial In Patients With Multiply Recurrent C. Difficile Infection

PATHFINDER is a ground-breaking Phase 2 clinical trial with ibezapolstat (IBZ) in patients with multiply-recurrent CDI (C. difficile Infection) (rCDI) that, together with results from the planned ASPIRE Phase 3 trial in the broader patient population for the treatment of acute CDI, has potential to shift the paradigm of treatment and prevention of rCDI from two agents to onePATHFINDER by itself in patients with multiply-recurrent CDI will inform elements of a planned active-controlled, Phase 3 registration trial in rCDI. Upon subsequent successful completion of PATHFINDER, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs* Acurx is well positioned to commence its international pivotal Phase 3 ASPIRE trial, subject to funding availability, having both FDA and EMA alignment on the Phase 3 clinical program and pathway to U.S. NDA and MAA in the EUAcurx has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMASTATEN ISLAND, N.Y., Sept. 29, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that the first patient has been enrolled in its new clinical trial (PATHFINDER) in patients with multiply recurrent C. difficile Infection (rCDI). This new, fully funded,PATHFINDER clinical trial is a pilot trial in approximately 20 patients with multiply-recurrent CDI (at least three episodes over the past 12 months), and will support filing of a U.S. NDA (New Drug Application) based on a single Phase 3 trial.ThePATHFINDER Phase 2 multicenter, open-label, single-arm study evaluates the efficacy and safety of ibezapolstat in the treatment and reduction of recurrence of CDI in patients who have experienced at least 3 episodes of CDI within the past 12 months. Participants will be treated with IBZ for 14 days and assessed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (to Week 24), and Extended Clinical Cure (to Week 24).Separately, the planned ASPIRE trial is of non-inferiority design with the primary efficacy analysis in the Modified Intent-To-Treat (mITT) population and will result in approximately 550 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin. The ASPIRE trial will be conducted when the Company has sufficient resources from public or private partnership(s) to fund this trial.