17.01.2024 13:34:51
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Acurx Announces Positive Microbiology And Microbiome Data For Ibezapolstat From Phase 2b Trial
(RTTNews) - Biopharmaceutical company Acurx Pharmaceuticals, Inc. (ACXP) announced Wednesday positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from its recently completed Phase 2b clinical trial in patients with Clostridoides difficile infection or CDI.
The data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin which had eradication of fecal C. difficile in 10 of 14 patients (71%).
In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent CDI recurrence.
The company noted that further analyses will be forthcoming in the first quarter of 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days.
The company said preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials.
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