Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of Clostridioides difficile Infection (CDI), supported by recent study findings that elucidate its selective activity against harmful bacteria while preserving beneficial gut microbiota [1][2][3] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, particularly those caused by Gram-positive bacteria [19] - The company's lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial designed to inhibit DNA polymerase IIIC, leading to bacterial cell death [19][13] Clinical Trial Progress - Ibezapolstat is preparing to enter international Phase 3 clinical trials, having received positive regulatory guidance from the European Medicines Agency (EMA) confirming the adequacy of the clinical and non-clinical data submitted [5][6] - The Phase 3 trial will involve an estimated 450 subjects, randomized in a 1:1 ratio to receive either ibezapolstat or standard-of-care vancomycin, with the primary efficacy analysis focusing on clinical cure rates and recurrence reduction [6][10] Study Findings - Recent research published in the Journal of Antimicrobial Agents and Chemotherapeutics highlights the microbiome-restorative potential of ibezapolstat, showing that it allows for the regrowth of beneficial gut microbiota while effectively targeting C. difficile [1][2][3] - The study utilized in silico genomic analysis to explain the narrower than expected spectrum of activity of ibezapolstat observed in clinical trials, indicating that certain beneficial taxa are naturally resistant to the drug [2][3] Efficacy and Safety Data - In combined Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96% (25 out of 26 patients), with no drug-related serious adverse events reported [9][10] - The treatment was well-tolerated, with mild gastrointestinal adverse events that resolved without treatment, and showed promising results in maintaining a healthy gut microbiome [9][12] Regulatory Designations - Ibezapolstat has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, which facilitate its development as a treatment for CDI [14] - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics to address this significant healthcare challenge [14][15]
Acurx Announces Publication of Positive Results from an In-Silico Study Predicting the Microbiome-Restorative Potential of Ibezapolstat in the Treatment of CDI