Acurx Pharmaceuticals(US:ACXP) Prnewswire·2025-07-24 11:01Core Viewpoint - Acurx Pharmaceuticals is preparing to discuss its Q2 2025 financial results and is advancing its lead antibiotic candidate, ibezapolstat, towards international Phase 3 clinical trials for treating C. difficile Infection (CDI) [1][4]. Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections [5]. - The company's lead product candidate, ibezapolstat, is designed to treat CDI and is ready for Phase 3 trials, with plans to initiate international clinical trials next year, pending financing [5]. Product Details - Ibezapolstat is a novel, orally administered antibiotic that acts as a Gram-Positive Selective Spectrum (GPSS®™) antibacterial, specifically targeting DNA polymerase IIIC to inhibit DNA replication in Gram-positive bacteria [3][5]. - The antibiotic has received positive regulatory guidance from the EMA, supporting its advancement to Phase 3 trials and potential submission for Marketing Authorization Application (MAA) in Europe [4]. Regulatory Status - Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA, which provides incentives for the development of new antibiotics [4]. - The FDA also granted "Fast Track" designation to ibezapolstat for CDI treatment, highlighting the urgent need for new antibiotics in this area [4]. Upcoming Events - Acurx Pharmaceuticals will host a conference call on August 12, 2025, at 8:00 am ET to discuss its financial results and provide a business update [2].