Ibezapolostat Phase 2 Results to be Presented at ESCMID 2024

Acurx Pharmaceuticals, a biopharmaceutical firm specializing in developing innovative antibiotics for challenging bacterial infections, has reported significant findings from its Phase 2 clinical trials of ibezapolstat, a novel antibiotic, at a prominent international conference. The 34th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), taking place in Barcelona from April 27 to 30, 2024, will host the presentation of these results.

The ibezapolstat trial focused on treating Clostridioides difficile Infection (CDI) and was led by Professor Kevin Garey from the University of Houston College of Pharmacy. The study was a comparative analysis against the standard antibiotic vancomycin. The Phase 2 trial was conducted in two segments; the initial open-label single-arm study (Phase 2a) was followed by a double-blind, randomized, active-controlled, non-inferiority segment (Phase 2b) across 28 clinical sites in the United States.

The Phase 2a segment involved 10 patients who received ibezapolstat orally, twice daily for 10 days, and showed a 100% cure rate at the end of treatment. The Phase 2b segment enrolled 32 patients who were randomized to receive either ibezapolstat or vancomycin for 10 days. The trial was designed to assess not only the clinical efficacy but also the pharmacokinetics and microbiome changes from baseline. The results indicated a 96% clinical cure rate for ibezapolstat, which was well-tolerated with mild gastrointestinal adverse events that resolved without treatment.

The trial was discontinued early due to its success, with the decision made in consultation with medical advisors and statisticians. The high rates of clinical cure and lack of safety concerns for both treatments led to the conclusion that an Independent Data Monitoring Committee's interim analysis was unnecessary. Acurx Pharmaceuticals is optimistic that ibezapolstat will demonstrate non-inferiority to vancomycin in Phase 3 trials, given the historical cure rate of approximately 81% for vancomycin.

Ibezapolstat is a first-in-class antibiotic candidate with a unique spectrum of activity that targets C. difficile while preserving other beneficial bacteria, potentially contributing to a healthy gut microbiome. It has been designated by the FDA as a Qualified Infectious Disease Product (QIDP) and granted "Fast Track" designation, highlighting its potential as a significant new treatment for CDI, which the CDC has identified as an urgent threat.

ESCMID's annual congress is a leading international forum in the field of clinical microbiology and infectious diseases, attracting over 14,000 participants and offering a diverse range of sessions, including keynotes, symposia, and workshops.

CDI is a significant medical issue in hospitals, long-term care facilities, and the community, with C. difficile being a common cause of healthcare-associated infections in U.S. hospitals. The infection can lead to severe inflammation and damage to the intestinal mucosa due to the production of toxins TcdA and TcdB. Bile acids play a crucial role in maintaining a healthy gut microbiome by inhibiting C. difficile growth, and ibezapolstat's effect on bile acid metabolism may contribute to its anti-recurrence properties.

Acurx Pharmaceuticals is dedicated to developing a new class of small molecule antibiotics targeting Gram-positive bacteria, including C. difficile, MRSA, VRE, and DRSP, aiming to address the urgent need for new treatments in the face of rising antibiotic resistance.