Accessibility StatementSkip Navigation STATEN ISLAND, N.Y., Sept. 30, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections announced receipt of a favorable opinion from the PDCO of the EMA on Acurx's Pediatric Investigation Plan (PIP) for ibezapolstat use in children with C. difficile infection (CDI). * Adapted from: Shirley DA, Torn ...

Core Viewpoint - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, to pivotal Phase 3 clinical trials for the treatment of Clostridioides difficile infection (CDI), with promising results from previous trials indicating high efficacy and safety [2][11][15]. Group 1: 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, particularly those caused by Gram-positive bacteria [23]. - The company's lead product candidate, ibezapolstat, is a DNA polymerase IIIC inhibitor designed to treat CDI and has received FDA QIDP and Fast-Track designations [2][19]. - Acurx's research and development pipeline includes antibiotic candidates targeting various multi-drug resistant bacteria, including MRSA and VRE [23]. Group 2: Clinical Trial Progress - Ibezapolstat is ready to advance to international pivotal Phase 3 clinical trials, following positive outcomes from Phase 2 trials, which demonstrated a Clinical Cure rate of 96% [2][15][16]. - The Phase 2 clinical trial included a multicenter, open-label segment and a double-blind, randomized segment, with a total of 42 patients treated for CDI [13][14]. - The Phase 2b trial showed that ibezapolstat-treated patients had a higher sustained clinical cure rate compared to those treated with vancomycin, indicating its potential superiority [16][17]. Group 3: Scientific Collaboration and Research - Acurx's research is conducted in collaboration with Leiden University Medical Center, focusing on the structural biology of DNA pol IIIC and its inhibitors, which has implications for developing new antibiotics [1][4][10]. - The unique conformation of ibezapolstat and its analogues suggests a conserved mechanism of action across Gram-positive bacteria, enhancing the understanding of its selectivity and efficacy [3][4]. - Ongoing research aims to elucidate the structure of pol IIIC from multidrug-resistant organisms, which will guide the rational design of new inhibitors [6][7]. Group 4: Market Need and Impact - CDI is a significant healthcare issue, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3%, highlighting the urgent need for new treatment options [20]. - The CDC has classified CDI as an urgent threat, underscoring the importance of developing effective antibiotics like ibezapolstat to combat antimicrobial resistance [19][20]. - Ibezapolstat's mechanism of maintaining a healthy gut microbiome while treating CDI may reduce the likelihood of recurrence, addressing a critical gap in current treatment options [17][22].