Acurx Reveals More Ph2b Ibezapolstat Results in CDI and Anthrax Susceptibility to ACX-375 Analogues

Acurx Pharmaceuticals, Inc., a biopharmaceutical company specializing in the development of new antibiotics for challenging bacterial infections, has announced promising new findings regarding its lead antibiotic candidate, ibezapolstat. The recent analyses extended data on ibezapolstat's positive impact on the gut microbiome, revealing an increase in beneficial bacteria and reduction of dysbiosis, along with strong anti-recurrence effects for Clostridioides difficile Infection (CDI).

The pharmacokinetics of ibezapolstat have also been confirmed, showing low systemic exposure and high colonic concentrations, which are beneficial for targeting CDI. In addition to its impact on CDI, ibezapolstat has shown activity against Anthrax (B. anthracis), including strains resistant to ciprofloxacin, through its ACX-375 analogues. These findings support the ongoing development of an Anthrax bioterrorism program.

The data was presented at the International C. difficile Symposium (ICDS) in Slovenia, emphasizing ibezapolstat's capability to preserve key gut bacteria while effectively combating CDI. A notable highlight from the presentation by Dr. Kevin Garey was the observation of unique microbiome signatures in vancomycin-treated patients who experienced CDI recurrence, suggesting potential predictive biomarkers for recurrence.

Acurx is preparing to advance ibezapolstat into international Phase 3 clinical trials for CDI treatment and is seeking regulatory guidance to initiate trials in the European Union, the United Kingdom, Japan, and Canada. The FDA has previously granted ibezapolstat both Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, facilitating its expedited development.

The Phase 2 clinical trial results for ibezapolstat were promising, with a 96% clinical cure rate observed in patients treated for CDI. The trial data showed eradication of C. difficile by the third day of treatment and an increase in healthy gut microbiota. Importantly, ibezapolstat demonstrated favorable outcomes in reducing CDI recurrence compared to vancomycin, driven by an increase in secondary bile acids that inhibit C. difficile growth.

The upcoming Phase 3 trials will aim to further demonstrate ibezapolstat's efficacy and safety. Acurx's development plan includes using a Modified Intent-To-Treat (mITT) population for primary efficacy analysis, in line with EMA recommendations, and involves around 450 subjects randomized to receive either ibezapolstat or standard-of-care vancomycin.

Acurx Pharmaceuticals remains focused on developing antibiotics with a Gram-Positive Selective Spectrum (GPSS®) that target specific bacterial enzymes, aiming to address critical bacterial threats such as MRSA and VRE. The company's efforts align with the urgent need for new antibiotics, particularly for CDI, which is a significant health threat with high infection and mortality rates.

In summary, Acurx Pharmaceuticals is progressing with the development of ibezapolstat, exhibiting strong potential for treating CDI and other serious bacterial infections while preserving a healthy gut microbiome. The company's strategic planning and regulatory engagements mark critical steps towards bringing this novel antibiotic to international markets.