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Acurx Reveals Promising New Data on Bile Acids and Gut Health from Phase 2b Trial of Ibezapolstat At IDWeek 2024

Acurx presents Phase 2 ibezapolstat CDI study results at IDWeek 2024; prepares for Phase 3 trials.

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  • Oct 22, 2024

  • Simantini Singh Deo

Acurx Reveals Promising New Data on Bile Acids and Gut Health from Phase 2b Trial of Ibezapolstat At IDWeek 2024

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical company focused on developing novel small-molecule antibiotics for challenging bacterial infections, announced the presentation of a scientific poster at the Infectious Diseases Society of America's IDWeek™ 2024 Conference held from October 16-19, 2024, in Los Angeles, CA.

The poster, presented by Kevin Garey, PharmD, MS, FIDSA, and Taryn A. Eubank, PharmD, BCIDP, on topic - A phase 2, randomized, double-blind study of ibezapolstat compared with vancomycin for the treatment of C. difficile infection: clinical and microbiome evaluation. 


In the Phase 2b clinical trial, ibezapolstat demonstrated a similar clinical cure, sustained clinical cure rates, and safety profile compared to vancomycin. Additionally, all five ibezapolstat patients monitored for three months after the end of treatment (EOT) experienced no recurrence. Favorable microbiome changes were observed in ibezapolstat-treated patients, showing increased Actinobacteriota and beneficial Bacillota. These patients also had reduced concentrations of fecal primary bile acids and higher ratios of secondary to primary bile acids compared to those treated with vancomycin.


"These exciting results demonstrate two properties of ibezapolstat which may contribute to the anti-recurrence effect. First, preserving and restoring beneficial bacterial classes in the gut provide resistance to recolonization by C. difficile.  Second, these data, presented for the first time, indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ibezapolstat-treated patients, providing another important mechanism to prevent recurrent CDI,” said Dr. Garey.


Acurx previously announced a successful End-of-Phase 2 meeting with the FDA and readiness to proceed with Phase 3 trials of ibezapolstat for treating C. difficile infection. They agreed with the FDA on critical aspects of the international Phase 3 clinical trial program and the complete non-clinical and clinical development plan for filing a New Drug Application (NDA) for marketing approval. Acurx is moving forward with plans for the Phase 3 trials and is preparing to seek regulatory guidance to begin trials in the European Union, followed by the UK, Japan, and Canada.


"This new impressive bile acid and microbiome data compliment and extend our knowledge of ibezapolstat's pharmacologic profile. These results, when added to previous work showing anti-virulence properties, preclinically, give us a high level of confidence that our excellent Phase 2 clinical results will be confirmed in our Phase 3 studies," commented Robert J. DeLuccia, Executive Chairman of Acurx.


The key elements for Acurx's two Phase 3 non-inferiority pivotal trials have been confirmed, including agreements on the protocol design, patient population, primary and secondary endpoints, and the size of the safety database. Following FDA recommendations and anticipating an EMA Scientific Advice Meeting, the primary efficacy analysis will use a Modified Intent-To-Treat (mITT) population in line with EMA requirements. 


This will involve around 450 participants in the mITT population, randomized 1:1 to receive either ibezapolstat or standard-of-care vancomycin. The trial will assess ibezapolstat's ability to achieve a clinical cure of C. difficile infection (CDI) two days after ten days of treatment and evaluate its potential to reduce CDI recurrence. If ibezapolstat shows non-inferiority to vancomycin, further analysis will be done to test for superiority.

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