Acurx’s ibezapolstat shows selective bacterial targeting

STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a small-cap biotech company with a market capitalization of $13.13 million and a strong cash position relative to debt according to InvestingPro, has shared study results indicating its lead antibiotic candidate, ibezapolstat, selectively targets harmful bacteria while preserving beneficial gut microbiota. The findings, published in the Journal of Antimicrobial Agents and Chemotherapeutics, suggest ibezapolstat’s interaction with DNA pol IIIC enzyme is conserved across harmful Bacillota phylum members, including C. difficile, but not in beneficial taxa like Lachnospiraceae and Oscillospiraceae.

The study, led by Jacob K. McPherson, PharmD, a PhD Pharmacology Candidate at the University of Houston, was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It utilized in silico methods to predict ibezapolstat’s spectrum of activity based on genomic analysis and phylogenetic tree construction of the pol IIIC target enzyme. This approach helped explain the antibiotic’s narrow activity spectrum observed in clinical trials, which has been linked to the regrowth of health-promoting gut microbiota.

Kevin Garey, PharmD, MS, FIDSA, co-author and Acurx Scientific Advisory Board member, highlighted the genomic differences in PolC between species that affect ibezapolstat binding, allowing beneficial microbes to resist the drug and confer health benefits.

Acurx’s Executive Chairman, Bob DeLuccia, underscored the importance of these results in progressing ibezapolstat’s clinical program and other systemic Gram-positive antibiotic discovery efforts. The company is preparing to advance ibezapolstat into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI).

Previously, ibezapolstat received FDA QIDP and Fast-Track Designation, as well as SME designation by the EMA. Positive regulatory guidance from the EMA supports the advancement of ibezapolstat’s Phase 3 program and, if successful, the submission of a Marketing Authorization Application in Europe.

The upcoming Phase 3 trials, designed as non-inferiority studies against vancomycin, will include an estimated 450 subjects and aim to demonstrate ibezapolstat’s efficacy in achieving clinical cure and reducing CDI recurrence. The company’s stock, currently trading at $0.78, has experienced significant volatility, falling over 75% in the past year. Despite this decline, analysts maintain ambitious price targets between $10-12 per share, suggesting substantial upside potential if the trials succeed. The Phase 2 clinical trial had shown a 96% clinical cure rate with ibezapolstat, which was well-tolerated with no drug-related serious adverse events.

This study provides a mechanistic explanation for ibezapolstat’s selective action, potentially offering a treatment for CDI that spares beneficial gut bacteria, thereby reducing the likelihood of infection recurrence. The information presented is based on a press release statement from Acurx Pharmaceuticals, Inc. With the next earnings report due on March 13, 2025, investors seeking deeper insights into ACXP’s financial health and growth prospects can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed metrics beyond what’s covered in this article.

In other recent news, Acurx Pharmaceuticals has made significant strides in advancing its antibiotic candidate, ibezapolstat, towards Phase 3 clinical trials for Clostridioides difficile Infection (CDI). The company has received positive feedback from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), indicating readiness to proceed with these trials. The Phase 3 trials will be non-inferiority studies comparing ibezapolstat to the standard-of-care treatment, vancomycin, and will involve approximately 450 subjects. Acurx’s Phase 2 trials demonstrated a 96% clinical cure rate for ibezapolstat, with a favorable safety profile and no serious drug-related adverse events.

Additionally, Acurx Pharmaceuticals has secured a new patent from the Japanese Patent Office for its DNA Polymerase IIIC Inhibitors, which are crucial to its ACX-375C program. This patent is part of the company’s broader strategy to expand its global patent portfolio. The FDA has recognized ibezapolstat as a Qualified Infectious Disease Product and granted it Fast Track designation. Acurx is also in discussions with health authorities in the U.S. and EU regarding pediatric development plans for ibezapolstat. Furthermore, the company plans to seek regulatory guidance to initiate clinical trials in Japan, Canada, and the United Kingdom (TADAWUL:4280).

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