Business
Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update
STATEN ISLAND, N.Y., March 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a clinical stage
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"STATEN ISLAND, N.Y., March 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (\"we\" or \"Acurx\" or the \"Company\"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the fourth quarter and full year ended December 31, 2023. \n\nHighlights of the fourth quarter ended December 31, 2023, or in some cases shortly thereafter, include:\nIn October 2023, we ended enrollment in our Phase 2b clinical trial of ibezapolstat, our lead antibiotic candidate, for the treatment of patients with C. difficile infection, or CDI.In November 2023, we reported top-line data from the Phase 2b clinical trial, including overall results from the full Phase 2 study, demonstrating an ibezapolstat clinical cure rate at end of 10-days' oral treatment, or EOT, of 96% (25 of 26 patients) which included 100% cure in Phase 2a (10 of 10 patients) and 94% in Phase 2b (15 of 16 patients) compared with the vancomycin control arm of 100% (14 of 14 patients) at EOT. No safety concerns were reported in either arm of the Phase 2b clinical trial and ibezapolstat was well tolerated in all patients in both the Phase 2a open label trial and in the Phase 2b vancomycin-controlled segment. In consultation with its scientific advisors, the Company determined that based on review of aggregate blinded data the Phase 2b vancomycin-controlled trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns. We also stated at that further data would be provided as they become available on secondary and exploratory endpoints from the Phase 2b trial segment, including sustained clinical cure data at 30 days after EOT, and Extended Clinical cure data up to 94 days as well as comparative data on the impact to the patient's microbiome.In December 2023, we announced the sustained clinical cure data. These data showed that in the Phase 2b clinical trial segment 100% or 15 out of 15 patients who were cured at EOT remained cured with no reinfection 30 days later while vancomycin experienced a reinfection rate of 14.3% (2 of 14 patients).In January 2024, the Company announced positive comparative microbiology and microbiome data for ibezapolstat in CDI patients from the Phase 2...