Acurx Presents New Bile Acid and Microbiome Data from Ph2b Ibezapolstat Trial in CDI Patients at IDWeek

Acurx Pharmaceuticals has presented promising findings on ibezapolstat, a novel antibiotic targeting C. difficile infections (CDI), at the Infectious Diseases Society of America (IDSA) IDWeek 2024 conference. The research highlighted the drug's potential benefits in preventing recurrences of CDI, a common and severe bacterial infection.

The Phase 2b clinical trial demonstrated that ibezapolstat's effectiveness in achieving clinical cure and its safety profile were comparable to vancomycin, a current standard treatment. Notably, patients treated with ibezapolstat exhibited no CDI recurrence during a three-month follow-up period. These patients also showed favorable microbiome outcomes, including increased beneficial bacterial populations and reduced levels of harmful primary bile acids, which are linked to CDI recurrence. This bile acid profile offers further insight into ibezapolstat's anti-recurrence properties.

Kevin Garey, a key investigator from the University of Houston College of Pharmacy, explained that the preservation of beneficial gut bacteria and the drug's influence on bile acids likely contribute to its effectiveness in preventing recurrence. These findings suggest that ibezapolstat supports gut health by promoting beneficial bacterial classes and altering bile acid metabolism to create an environment less conducive to CDI.

Robert J. DeLuccia, Executive Chairman of Acurx, expressed confidence that the new microbiome and bile acid data reinforce previous findings and support the ongoing development of ibezapolstat. The company is preparing for international Phase 3 clinical trials, which will be critical for securing regulatory approval and bringing the drug to market.

Acurx has already secured agreements with the FDA on the key elements of the Phase 3 trial design, including patient population, primary and secondary endpoints, and the size of the safety database. These trials will compare ibezapolstat to vancomycin, with an estimated 450 participants randomized to receive either treatment. The primary efficacy analysis will focus on a Modified Intent-To-Treat (mITT) population, as recommended by the FDA and in line with European Medicines Agency (EMA) guidelines. The goal is to demonstrate ibezapolstat's non-inferiority to vancomycin in achieving clinical cure and reducing CDI recurrence.

Previously, ibezapolstat received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA, highlighting its potential as a significant advancement in CDI treatment. The drug's unique mechanism targets DNA polymerase IIIC, a critical enzyme in Gram-positive bacteria, including C. difficile. By sparing other beneficial bacteria, ibezapolstat helps maintain a healthy gut microbiome, further supporting its role in reducing CDI recurrence.

C. difficile infection remains a major public health issue, with nearly 500,000 cases and approximately 20,000 related deaths annually in the United States. Current treatments have a high recurrence rate, underscoring the need for new therapeutic options like ibezapolstat.

The IDSA conference, where these findings were presented, is a key event for professionals specializing in infectious diseases, bringing together experts to share the latest research and advancements. The positive results from ibezapolstat's Phase 2 trials mark a significant step forward, reaffirming Acurx's commitment to developing effective treatments for difficult-to-treat bacterial infections.

Overall, ibezapolstat shows great promise as a future treatment for CDI, with its potential to reduce recurrence and maintain gut health, which could significantly impact patient outcomes and public health.