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Acurx Pharma Discontinues Phase 2b Trial For Ibezapolstat To Treat C. Difficile Infection
(RTTNews) - Biopharmaceutical company Acurx Pharmaceuticals, Inc. (ACXP) announced Monday that the Company has discontinued the Phase 2b clinical trial of its lead antibiotic candidate, ibezapolstat, for the treatment of patients with Clostridioides difficile infection (CDI) due to success.
The Company made this decision in consultation with its medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19.
The Company has determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns.
Accordingly, the Independent Data Monitoring Committee will not be required to perform an interim analysis of this Phase 2b trial data as originally planned and the Company has discontinued the trial.
Acurx will analyze the data and report topline efficacy results promptly. The Company anticipates that this decision will allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.
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