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Acurx Announces Positive Phase 2b Results Showing 100% of Patients Who Had Clinical Cure with Ibezapolstat Also Had Sustained Clinical Cure
All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at end of treatment (EOT) remained free of C. difficile Infection (CDI)
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at 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 EOTFurther analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints, from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days and comparative effects vs vancomycin on the gut microbiomePreparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trialsSTATEN ISLAND, N.Y., Dec. 11, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (\"Acurx\" or the \"Company\"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive Phase 2b results showing 100% of CDI patients who had CC with ibezapolstat, the company's late-stage antibiotic candidate, also had SCC.\n\nThe efficacy results from the Phase 2 trial (Phase 2a and Phase 2b) are summarized in the table below:\nClinical Cure (CC)\nat EOT\nSustained Clinical Cure (SCC)\nOne Month After EOT for all evaluable patients\nSustained \nClinical Cure* (SCC) One Month After EOT \nibezapolstat Phase 2a\n10/10 (100%)\n10/10 (100%)\n10/10 (100%)\nibezapolstat Phase 2b\n15/16 (94%)\n15/16 (94%)\n15/15 (100%)\nibezapolstat Phase 2a + \nPhase 2b Combined\n25/26 (96%)\n25/26 (96%)\n25/25 (100%)\nvancomycin \n14/14 (100%)\n12/14 (86%)\n12/14 (86%)\n*Sustained Clinical Cure was evaluated only for patients who were CC at EOT. \nKevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member stated: \"These results help validate our ongoing scientific investigations into the anti-CDI recurrence properties of ibezapolstat including maintenance and regrowth of healthy gut micr...