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Acurx Pharmaceuticals Announces Successful Completion and Early Discontinuation of the Ibezapolstat Phase 2b Trial for Treatment of C. difficile Infection
Based on observed aggregate blinded data the Company has determined that both treatments, ibezapolstat and the control antibiotic vancomycin, have performed
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"Based on observed aggregate blinded data the Company has determined that both treatments, ibezapolstat and the control antibiotic vancomycin, have performed as expectedHigh rates of Clinical Cure were observed without any emerging safety concernsData will be analyzed and topline efficacy results will be reported as soon as possibleThis successful milestone will allow advancement of this first-in-class, FDA QIDP/Fast Track-designated antibiotic candidate to Phase 3 clinical trials more expeditiouslySTATEN ISLAND, N.Y., Oct. 2, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (\"Acurx\" or the \"Company\"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today 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. \n\nAccordingly, 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. \nRobert J. DeLuccia, Executive Chairman of Acurx, stated: \"Considering the totality and weight of evidence of our preclinical, Phase 1 and Phase 2a clinical results and now with the observed aggregate blinded data, we determined it was in the best interests of the Company and its shareholders to discontinue the Phase 2b clinical trial early and prepare for Phase 3 clini...