Acurx Pharmaceuticals Presents Ibezapolstat Phase 2 CDI Trial Results at Conference

Acurx Pharmaceuticals, Inc. has shared promising results from the Phase 2 clinical trial of their novel antibiotic, ibezapolstat, for treating Clostridioides difficile Infection (CDI). Presented at the 17th Biennial Congress of the Anaerobe Society of the Americas, the data underscores ibezapolstat's capability in treating CDI while fostering positive changes in the gut microbiome.

Dr. Taryn A. Eubank from the University of Houston College of Pharmacy delivered the presentation on ibezapolstat's clinical efficacy, highlighting favorable microbiome alterations in treated patients. These changes include an increased proportion of Actinobacteria and preservation of beneficial Firmicute phylum known for their roles in bile acid homeostasis and short-chain fatty acid metabolism. These outcomes are consistent with earlier studies.

Dr. Kevin Garey, a leading microbiologist in the trial, emphasized the robust microbiome development plan incorporated into ibezapolstat’s clinical development. The results validate the anticipated anti-recurrence effect of ibezapolstat, setting a new benchmark for CDI-targeted antibiotics.

Robert J. DeLuccia, Acurx's Executive Chairman, noted the dual mechanism of action of ibezapolstat, which both treats the infection and supports gut microbiome health, as a crucial competitive advantage. The company is gearing up for Phase 3 clinical trials internationally, aiming for a New Drug Application (NDA) submission.

The Anaerobe Society of the Americas, founded in 1992, organized the event. The society promotes anaerobic bacteriology through biennial congresses, bringing together global experts.

Ibezapolstat’s Phase 2 clinical trial consisted of two segments. Phase 2a was an open-label study involving 10 patients, all of whom showed infection clearance after 10 days of treatment. The success of Phase 2a led to an early transition to the Phase 2b study. In Phase 2b, 32 CDI patients were randomized to receive either ibezapolstat or vancomycin, the standard treatment, with both groups showing high clinical cure rates. Ibezapolstat’s 96% cure rate in Phase 2 was encouraging compared to vancomycin’s historical cure rate of about 81%.

The Phase 2b trial was halted early due to its success, confirmed through blinded clinical observations and supported by advisors. The decision was influenced by factors including cost and COVID-19-related enrollment challenges. The early termination bypassed the need for further interim analysis.

A crucial aspect of the trials was the evaluation of pharmacokinetics and microbiome changes, particularly the anti-recurrence properties. Ibezapolstat demonstrated a rapid eradication of C. difficile and an overgrowth of beneficial microbiota. Notably, there was a significant increase in secondary bile acids during and after treatment, which correlates with resistance to C. difficile colonization.

Acurx also reported positive extended clinical cure (ECC) data, showing no recurrent infections in patients monitored for up to three months post-treatment with ibezapolstat.

Ibezapolstat, designated as a Qualified Infectious Disease Product (QIDP) and granted "Fast Track" status by the FDA, is poised to enter Phase 3 trials. It aims to be a Gram-Positive Selective Spectrum (GPSS®) antibacterial, primarily targeting DNA polymerase IIIC in Gram-positive bacteria, minimizing the impact on beneficial gut microbiota.

CDI remains a pressing health issue in the U.S., with nearly half a million infections and significant mortality annually. Current treatments have a notable recurrence rate, underscoring the urgent need for effective new antibiotics.

In summary, ibezapolstat shows great promise in treating CDI while promoting a healthy gut microbiome. Acurx Pharmaceuticals is preparing for the next phase of clinical trials, potentially offering a new standard of care for CDI patients worldwide.