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Acurx Announces First Patient Enrolled in Phase 2b Clinical Trial of its Lead Antibiotic for Treatment of Clostridioides difficile Infection (CDI)
- First patient enrolled in Phase 2b comparative trial segment vs vancomycin, current standard of care - Previously completed Ph2a segment of this Phase 2
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"- First patient enrolled in Phase 2b comparative trial segment vs vancomycin, current standard of care\n - Previously completed Ph2a segment of this Phase 2 trial demonstrated 100% clinical cure and 100% sustained clinical cure in patients with CDI\n - Comparing ibezapolstat to vancomycin, Phase 2b will add to the pioneering data from Phase 1 and from Phase 2a patients demonstrating ibezapolstat's favorable effects on gut microbiome and bile acids\n - Ibezapolstat is FDA QIDP and Fast Track Designated for priority review\n\n\nSTATEN ISLAND, N.Y., Dec. 6, 2021 /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 first patient has been enrolled in its Phase 2b clinical trial of ibezapolstat, its lead antibiotic candidate, against the standard of care to treat CDI, vancomycin, in a 64 patient double-blind randomized trial expected to be completed mid-2022. C. difficile bacteria remains on the Centers for Disease Control and Prevention (CDC) Urgent Threat list, highlighting the need for new therapeutics to treat CDI. Ibezapolstat is FDA QIDP and Fast Track Designated for priority review.\nRobert J. DeLuccia, Executive Chairman of Acurx, stated, \"With the excellent clinical results and very good safety and tolerability demonstrated in the Phase 2a segment of this ongoing trial, we validated the bacterial pol IIIC enzyme as a therapeutic target for ibezapolstat, our first product candidate in our new class of antibiotics. Additionally, this trial segment showed potentially beneficial effects of ibezapolstat on the intestinal microbiome and bile acid metabolism.\" He further stated that \"Initiating this Phase 2b segment is a very important clinical development milestone for our company. We look forward to successfully completing enrollment in mid-2022.\"\nAbout the Ibezapolstat Phase 2 Clinical Trial. The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by this double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 12 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial is designe...