CRS3123, an investigational antibiotic for C. difficile infection, demonstrated 97% clinical cure rates and significantly lower recurrence (4% vs 23% for vancomycin) in a Phase 2 trial. The narrow-spectrum drug better preserves gut microbiome health and secondary bile acid synthesis compared to standard vancomycin treatment. These positive results support advancing CRS3123 into Phase 3 development.
Acurx Pharmaceuticals announced a new clinical trial program for ibezapolstat in patients with recurrent C. difficile infection, building on Phase 2 results showing 96% clinical cure rates with no recurrence while sparing the gut microbiome.
Acurx Pharmaceuticals will discuss full year and fourth quarter 2025 financial results on March 13, 2026, and provide updates on ibezapolstat, its lead antibiotic candidate preparing for international Phase 3 trials for C. difficile infection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06533800 |
Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection |
NOT_YET_RECRUITING | |
| NCT06237452 |
VE303 for Prevention of Recurrent Clostridioides Difficile Infection |
RECRUITING | PHASE3 |
| NCT05508607 |
Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention |
COMPLETED | |
| NCT04241744 |
Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI |
WITHDRAWN | PHASE4 |
| NCT04100603 |
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection |
WITHDRAWN | |
| NCT03788434 |
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection |
COMPLETED | PHASE2 |
| NCT03621657 |
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation |
COMPLETED | PHASE2 |
| NCT03497806 |
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection |
COMPLETED | PHASE2 |
| NCT03462459 |
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection |
COMPLETED | PHASE2 |
