Acurx Pharmaceuticals Inc ACXP released Phase 2b results showing 100% of C. difficile Infection (CDI) patients who had clinical cure (CC) with ibezapolstat, also had Sustained Clinical Cure (SCC).
All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at the end of treatment (EOT) remained free of C. difficile Infection (CDI) recurrence through one month after EOT for a Sustained Clinical Cure (SCC) rate of 100%.
2 of 14 patients treated with standard of care, oral vancomycin, experienced recurrent infection within one month after EOT for a SCC of 86%
100% of the 25 ibezapolstat-treated patients in Phase 2 (Phase 2a and 2b) who had CC at EOT remained cured through one month after EOT.
Further analyses are expected in Q1 2024, as data become available, regarding other endpoints, including Extended Clinical Cure (ECC) data up to 94 days and comparative effects versus vancomycin on the gut microbiome.
According to Stuart Johnson, Professor of Medicine, Loyola University (Infectious Disease) and Acurx Scientific Advisory Board member, “Although vancomycin is still an effective treatment, CDI patients treated with oral vancomycin experience a recurrence rate of 18-23%. Ibezapolstat, by virtue of its novel mechanism of action, lack of cross-resistance with any marketed antibiotics, narrow antibacterial spectrum, and selective effects on the gut microbiome, appears to be a promising potential new addition to our therapeutic armamentarium.”
The company is preparing to meet with the FDA, the European Medicines Agency, and other global regulatory agencies and advance to international Phase 3 clinical trials.
Price Action: ACXP shares are down 6.5% at $3.74 on the last check Monday.
Image and article originally from www.benzinga.com. Read the original article here.