Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI), with recent study results indicating its potential competitive advantage over existing antibiotics [1][5][19] 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 CDI [19] - The company’s lead product candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS®) antibacterial that inhibits DNA replication in Gram-positive bacteria [19][13] Clinical Trial Progress - Acurx has received positive regulatory guidance from the European Medicines Agency (EMA) for its Phase 3 program, which includes two planned international trials designed to demonstrate non-inferiority to vancomycin [5][6] - The Phase 2 clinical trials showed a Clinical Cure rate of 96% for ibezapolstat, with 100% of patients remaining cured one month after treatment [9][10] Study Findings - A recent study published in the Journal of Antimicrobial Agents and Chemotherapeutics compared the gut microbiome effects of ibezapolstat with other CDI antibiotics, revealing that ibezapolstat has a narrower spectrum of microbiome alteration compared to broader-spectrum antibiotics like vancomycin and metronidazole [2][3] - The study indicated that ibezapolstat treatment resulted in less pronounced changes in microbiome diversity and increased beneficial bacteria, which may contribute to its potential advantages in treating CDI [2][3][12] Regulatory Designations - Ibezapolstat has been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, highlighting its importance in addressing urgent medical needs [14][19] - The CDC has classified C. difficile as an urgent threat, emphasizing the necessity for new antibiotics like ibezapolstat [14][15] Market Context - CDI is a significant healthcare issue, with estimates of approximately 600,000 infections annually in the U.S. and a mortality rate of about 9.3% [16][15] - The recurrence rate for current CDI treatments ranges from 20% to 40%, indicating a substantial market opportunity for more effective therapies like ibezapolstat [16]
Acurx Announces Publication of Nonclinical In Vivo Data Differentiating Ibezapolstat's Gut Microbiome Effects from Other Anti-CDI Antibiotics