Acurx enrolls first patient in PATHFINDER trial for C. difficile

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced Sept. 29 that the first patient has been enrolled in its PATHFINDER Phase 2 clinical trial, evaluating ibezapolstat in patients with multiply-recurrent C. difficile infection (rCDI).

The fully funded, multicenter, open-label, single-arm pilot trial will enroll approximately 20 patients who have experienced at least three episodes of CDI within the past 12 months. Participants will receive ibezapolstat for 14 days and be assessed for clinical cure, sustained clinical cure, recurrence rate through week 24, and extended clinical cure through week 24.

Acurx stated that data from PATHFINDER, if successful, would support a U.S. New Drug Application filing based on a single Phase 3 trial. The company also plans to seek FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs.

A separate planned Phase 3 trial, called ASPIRE, would enroll approximately 550 subjects randomized 1:1 to ibezapolstat or vancomycin. Acurx said the ASPIRE trial is contingent on securing sufficient funding from public or private sources.

The FDA indicated at a July 13, 2026 Type C Meeting that it is open to discussing an NDA submission based on a single Phase 3 trial, depending on the totality of clinical evidence. The agency noted that acceptability of one Phase 3 trial is determined on a case-by-case basis.

Ibezapolstat holds FDA Qualified Infectious Disease Product and Fast Track designations, both granted in 2018 and 2019 respectively. Acurx has also received Small and Medium-sized Enterprise designation from the European Medicines Agency.

Executive Chairman Bob DeLuccia said in a statement: "We believe ibezapolstat has the potential to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI, potentially shifting the paradigm of treatment and prevention of rCDI from two agents to one."

According to the press release, CDI affects approximately 500,000 patients annually in the U.S., resulting in roughly 30,000 deaths and an estimated public health cost of approximately $5 billion, of which $2.8 billion is attributed to rCDI.

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