Business
Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update
STATEN ISLAND, N.Y., March 16, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical
About this update from Acurx Pharmaceuticals, Inc.
[{"type":"text","content":"STATEN ISLAND, N.Y., March 16, 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 certain financial and operational results for the fourth quarter and full year ended December 31, 2022. \nHighlights of the fourth quarter and full year ended December 31, 2022 include:\nAcurx continues to enroll patients in its Phase 2b clinical trial, which includes 28 U.S. sites (up from the initial 12 clinical trial sites), in patients with C. difficile infection (CDI) with an interim review of clinical data anticipated in mid-2023;The Phase 2b clinical trial will compare the efficacy of oral ibezapolstat, the Company's lead antibiotic candidate, to oral vancomycin, the current standard of care for CDI;Based on the blinded observed data from the ongoing Ph2b clinical trial to date, in January 2023, the Company filed a protocol amendment to its Investigational New Drug Application (IND) with FDA to allow for an Independent Data Monitoring Committee (IDMC) to review interim clinical data. If acceptable to FDA, the IDMC will review the clinical data upon enrollment of 36 patients in the Ph2b clinical trial. The Company currently has enrolled 25 patients in the Ph2b clinical trial. The IDMC will determine and recommend to the Company whether the most appropriate course of action forward is to early terminate the Ph2b clinical trial (as the Company had done with the Ph2a clinical trial) or to continue patient enrollment. The Company intends to report available data promptly after the IDMC conducts this interim review. The Company assembled its IDMC during this first quarter of 2023 for this purpose.The Company has continued its R&D collaboration with Leiden University Medical Center (Holland) to further evaluate the mechanism-of-action of Acurx's inhibitors against the DNA pol IIIC enzyme, which is the bacterial target of our antibiotic product pipeline for the systemic treatment (IV and oral) of other gram-positive bacterial infections. Data generated from this program was critical to include in a recent grant application for $11.3 million of non-dilutive funding (described below) with a decision anticipated in April 2023. Based on this successful collaboration, LU...