Acurx Publishes Promising Phase 2b CDI Trial Data for Ibezapolstat in Lancet Microbe

June 17, 2025

DENVER, Colo., Jun 17, 2025 (247marketnews.com)- Acurx Pharmaceuticals (NASDAQ:ACXP) announced today the publication of positive Phase 2b clinical trial results for its lead candidate, ibezapolstat, in Lancet Microbe. The data highlight a 94% clinical cure rate in patients with Clostridioides difficile infection (CDI), with 100% of cured patients remaining recurrence-free one month after end-of-treatment (EOT). By comparison, patients treated with standard-of-care vancomycin saw a 14% recurrence rate over the same period. When combined with Phase 2a data, ibezapolstat achieved a 100% sustained clinical cure in all 25 patients with no recurrence after one month, and no relapses among those followed for up to three months.

The senior author, Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, stated, “The clinical need for a new antibiotic, like IBZ, to treat CDI is underscored by a study recently published in Clinical Infectious Diseases conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding.”

In addition to this latest publication, two prior peer-reviewed studies support ibezapolstat’s distinct advantage: one demonstrating its preservation of the gut microbiome and another highlighting its microbiome-restorative potential through in-silico modeling.

Bob DeLuccia, Acurx’s Executive Chairman, commented, “This Lancet Microbe article complements the body of our published data to date, the totality of which establishes a comprehensive and formidable dossier to support our optimism for a successful Phase 3 clinical program and, if successful, first choice of IBZ as a front-line treatment for CDI. Our publications include data on IBZ chemistry, mechanism of action, microbiological activity, in vivo efficacy in the hamster model, human efficacy and safety, and favorable effects on the gut microbiome and bile acid metabolism.”

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