Acurx’s Ibezapolstat Achieves High Cure Rates For C. difficile In Phase 2b Study Published In The Lancet Microbe

Acurx Pharmaceuticals, a late-stage biotech firm developing novel antibiotics, has published the results of its Phase 2b clinical study of ibezapolstat (IBZ) in The Lancet Microbe. The study compared IBZ to vancomycin in treating adults with Clostridioides difficile infection (CDI), a serious gastrointestinal condition with limited effective treatment options. The results showed that IBZ was safe, well-tolerated, and potentially more effective than the current standard-of-care antibiotics, with strong, sustained clinical cure (SCC) rates and minimal impact on the gut microbiome.

Acurx's Executive Chairman, Bob DeLuccia, commented, "This Lancet Microbe article complements the body of our published data to date, the totality of which establishes a comprehensive and formidable dossier to support our optimism for a successful Phase 3 clinical program and, if successful, first choice of IBZ as a front-line treatment for CDI. Our publications include data on IBZ chemistry, mechanism of action, microbiological activity, in vivo efficacy in the hamster model, human efficacy and safety, and favorable effects on the gut microbiome and bile acid metabolism." 

Conducted across U.S. medical centers, the study demonstrated high clinical cure (CC) and SCC rates in patients treated with IBZ, with no recurrence of infection. In contrast to existing treatments like vancomycin and fidaxomicin, both of which face challenges with recurrence and antimicrobial resistance, IBZ not only treated CDI effectively but also preserved the gut’s beneficial bacteria, which play a crucial role in preventing reinfection. These findings build on earlier Phase 1 and 2a results, reinforcing the drug's potential as a next-generation therapy.

Bob DeLuccia further stated, "Data from our Phase 3 pivotal trials, if successful, will form the foundation for our continually evolving and attractive value proposition including in-market competitive advantage compared to vancomycin and fidaxomicin. Additionally, continuing optimization of our 'home-grown and made-in-America" supply chain will ensure scalability and reliability to be accessible and affordable worldwide".

The study was led by Professor Kevin Garey, PharmD, a recognized expert in infectious disease pharmacotherapy and a contributor to the IDSA CDI treatment guidelines. He emphasized the limitations of current CDI treatments and the pressing need for alternatives. With promising safety and efficacy data now peer-reviewed, Acurx is preparing to advance IBZ into Phase 3 international trials, positioning it as a possible new standard of care in CDI treatment.

 Dr. Garey also said, "The clinical need for a new antibiotic, like IBZ, to treat CDI is underscored by a study recently published in Clinical Infectious Diseases conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding."