USPTO Grants Acurx New Patent for Ibezapolstat to Treat CDI and Improve Gut Health

Acurx Pharmaceuticals, Inc., a biopharmaceutical company specializing in advanced antibiotics for challenging bacterial infections, announced the grant of a new patent by the United States Patent and Trademark Office (USPTO) on July 16, 2024. The patent pertains to ibezapolstat, an antibiotic aimed at treating C. difficile Infection (CDI), while also reducing recurrence rates and supporting gut microbiome health. This patent is the latest addition to Acurx’s portfolio, reflecting the company’s ongoing efforts to secure its proprietary antimicrobial technologies.

Robert J. DeLuccia, Executive Chairman of Acurx, emphasized the significance of the patent, highlighting ibezapolstat’s beneficial effects on the gut microbiome and its potential to curb CDI recurrence. DeLuccia expressed optimism about ibezapolstat's unique mechanism of action, which could offer a competitive edge over existing antibiotics and improve patient outcomes while lowering healthcare costs.

David P. Luci, President & CEO of Acurx, echoed these sentiments, noting that the new patent underscores the potential of ibezapolstat as a two-dimensional antibiotic. This means it not only effectively treats infections comparable to current antibiotics but also helps restore the microbiome and prevent reinfections, a notable advancement for CDI treatments.

Acurx had earlier announced a successful FDA End-of-Phase 2 meeting, securing agreements on key elements to advance ibezapolstat into Phase 3 clinical trials for CDI treatment. The company plans to seek guidance for initiating clinical trials in the European Union, the United Kingdom, Japan, and Canada.

The Phase 2 clinical trial for ibezapolstat included a multicenter, open-label single-arm segment (Phase 2a), followed by a double-blind, randomized, active-controlled, non-inferiority segment (Phase 2b) across 28 US clinical trial sites. The trial evaluated ibezapolstat’s clinical efficacy, pharmacokinetics, and microbiome changes, continuing to test its anti-recurrence properties. Key elements for two Phase 3 non-inferiority pivotal trials were confirmed, including protocol design, patient population, and primary and secondary endpoints.

The Phase 2a segment involved treating 10 patients with CDI using ibezapolstat, all of whom were cured by the end of the treatment and followed for recurrence. The Trial Oversight Committee recommended early termination of the Phase 2a study after achieving 100% cure rates, advancing to the Phase 2b segment. In the Phase 2b trial, 32 patients were randomized to receive either ibezapolstat or standard-of-care vancomycin, with high rates of clinical cure observed across the trial.

The successful conclusion of the Phase 2b trial led to its early termination based on blinded clinical observations, eliminating the need for interim analysis. The trial demonstrated that ibezapolstat was well-tolerated, with no serious adverse events or drug-related treatment withdrawals. The pooled Phase 2 clinical cure rate for ibezapolstat was 96%, compared to the historical cure rate of approximately 81% for vancomycin.

Acurx’s approach includes evaluating pharmacokinetics and microbiome changes, focusing on anti-recurrence properties and bile acid metabolism. Phase 2a data showed complete eradication of C. difficile by day three of treatment and favorable changes in bile acid concentration, suggesting a reduced likelihood of CDI recurrence compared to vancomycin.

Ibezapolstat, Acurx’s lead antibiotic candidate, is set to advance to international Phase 3 clinical trials. It is a novel, orally administered antibiotic designed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial, the first of a new class of DNA polymerase IIIC inhibitors. Ibezapolstat’s selective activity supports the maintenance of a healthy gut microbiome.

Designated by the FDA as a Qualified Infectious Disease Product (QIDP) for CDI and granted “Fast Track” status, ibezapolstat addresses an urgent need for new antibiotics to treat CDI, a significant medical problem with rising incidence and mortality rates. Acurx remains committed to developing innovative antibiotics that target challenging bacterial infections while preserving the gut microbiome's health.