Staten Island, N.Y. – September 29, 2026 -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) has enrolled the first patient in its PATHFINDER clinical trial evaluating ibezapolstat in patients with multiply-recurrent Clostridioides difficile infection (rCDI), a condition affecting up to 40% of patients treated with vancomycin after multiple prior episodes.
Fully funded pilot trial targets approximately 20 patients with severe recurrence history
The Phase 2 PATHFINDER study is a multicenter, open-label, single-arm trial enrolling patients who have experienced at least three CDI episodes within the past 12 months. Participants receive ibezapolstat for 14 days, with assessments for Clinical Cure at Day 16, Sustained Clinical Cure at Day 42, and recurrence rates tracked through Week 24.
Trial data will feed into planned Phase 3 ASPIRE study and single-trial NDA strategy
Acurx intends to use PATHFINDER results to inform an active-controlled Phase 3 registration trial in rCDI. Following a Type C Meeting with the FDA on July 13, 2026, the agency indicated openness to a Pre-NDA discussion on submitting a New Drug Application based on a single Phase 3 trial, contingent on the robustness of efficacy and safety data generated by that milestone.
ASPIRE trial to randomize 550 patients against standard-of-care vancomycin
The separately planned ASPIRE trial is a non-inferiority study with a Modified Intent-To-Treat population of approximately 550 subjects, randomized 1:1 between ibezapolstat and vancomycin. The FDA has agreed to the trial design and confirmed that successful results could support indications for both acute CDI treatment and recurrence reduction. Acurx will launch ASPIRE once it secures sufficient public or private funding.
Regulatory designations position Acurx for parallel U.S. and EU filings
Ibezapolstat holds FDA Qualified Infectious Disease Product and Fast-Track designations, alongside Small and Medium-sized Enterprise status from the EMA. The company states it has alignment with both the FDA and EMA on its Phase 3 program and pathway toward a U.S. NDA and EU Marketing Authorization Application.
Bob DeLuccia, Acurx's Executive Chairman, said the company believes ibezapolstat could become the first agent to demonstrate clinical success in both treating CDI and preventing rCDI, consolidating a two-agent treatment paradigm into one. He cited the disease's public health burden: approximately 500,000 CDI cases annually in the U.S., roughly 30,000 related deaths, and an estimated $5 billion in annual healthcare costs, of which $2.8 billion is tied to recurrent infections.
Recurrence rates under current standards of care remain high
Published data show rCDI incidence ranging from 4% to 19.5% after fidaxomicin treatment and 17% to 27% after vancomycin, climbing to 40% in patients with multiple prior episodes. Phase 2 data on ibezapolstat, including microbiome and bile acid metabolism findings, were published in The Lancet in August 2025.