Ibezapolstat Shows Promising Cure Rates in Phase 2b CDI Trial

In the recently concluded Phase 2b clinical trial, all patients treated with ibezapolstat for Clostridioides difficile infection (CDI) showed no signs of infection recurrence after a three-month observation period. Acurx Pharmaceuticals, the developer of ibezapolstat, is now preparing for regulatory discussions and the progression to Phase 3 trials on a global scale. The antibiotic has already been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track designations, indicating its potential significance in treating CDI.

The Phase 2b study was part of a larger clinical trial evaluating ibezapolstat's efficacy in treating CDI. It included a follow-up period to monitor the long-term effects of the treatment, with a focus on preventing infection relapses. The study's success is measured by clinical cure and the absence of CDI recurrence within specific timeframes post-treatment. Dr. Garey highlighted the importance of the extended observation period, noting its significance in confirming the durability of ibezapolstat's cure and anti-recurrence effects.

Robert J. DeLuccia, Executive Chairman of Acurx, emphasized the significance of the trial's results, which build on previous Phase 2 findings showing high clinical cure rates and no safety concerns. He expressed optimism about the upcoming Phase 3 trials and the potential for ibezapolstat to meet or exceed the standard of care, oral vancomycin.

David P. Luci, President & CEO of Acurx, noted the anticipated benefits of ibezapolstat in the CDI treatment market, expecting it to offer a competitive edge in 2024. He also mentioned the company's anticipation that ibezapolstat could be priced competitively, providing a comprehensive package of clinical efficacy, microbiome health, safety, and cost-effectiveness.

The Phase 2 trial included both an open-label segment and a double-blind, randomized segment, with the latter involving 32 patients receiving either ibezapolstat or vancomycin. The trial was discontinued early due to its success, with high cure rates observed for both treatments and no new safety concerns emerging. This decision is expected to facilitate a quicker transition to Phase 3 trials.

Ibezapolstat is a novel antibiotic with a unique spectrum of activity that targets C. difficile while preserving other beneficial bacteria, potentially contributing to a healthy gut microbiome. It has been recognized by the FDA for its potential in treating CDI, a significant healthcare concern with high infection and mortality rates in the U.S.

The Phase 2 trial also examined the effects of ibezapolstat on bile acid metabolism, which is crucial for maintaining a balanced gut microbiome. The results indicated that ibezapolstat may reduce the likelihood of CDI recurrence compared to vancomycin, by influencing the levels of primary and secondary bile acids.

Acurx Pharmaceuticals is dedicated to developing small molecule antibiotics with a Gram-positive selective spectrum to combat challenging bacterial infections, including CDI, MRSA, VRE, and DRSP. The company's innovative approach targets specific bacterial enzymes, offering a new frontier in antibiotic therapy.