JPO Grants Acurx Pharmaceuticals Patent in Japan for DNA Polymerase IIIC Inhibitors

Core Viewpoint - Acurx Pharmaceuticals has received a new patent in Japan for DNA Polymerase IIIC Inhibitors, which is crucial for the development of its antibiotic candidate ibezapolstat for treating C. difficile Infection (CDI) [1][2] Company Developments - Acurx has expanded its patent portfolio with three U.S. patents, one Israeli patent, and now a Japanese patent, all related to its ACX-375C program [1] - The company is preparing for Phase 3 clinical trials for ibezapolstat, having received positive regulatory guidance from the EMA [2][3] - The Phase 3 trials will involve approximately 450 subjects, randomized in a 1:1 ratio to receive either ibezapolstat or standard care vancomycin [3] Clinical Trial Insights - The Phase 2 clinical trial demonstrated a 96% Clinical Cure rate for ibezapolstat, with 100% cure in the Phase 2a segment [6][7] - The Phase 2b trial showed that ibezapolstat was well-tolerated, with no serious adverse events reported [7] - Ibezapolstat treatment led to favorable changes in bile acid metabolism, which may reduce the likelihood of CDI recurrence [8][12] Market Context - 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% [11] - The CDC has classified C. difficile as an urgent threat, highlighting the need for new antibiotics [10] Product Overview - Ibezapolstat is a novel, orally administered antibiotic targeting Gram-positive bacteria, specifically designed to maintain a healthy gut microbiome while treating CDI [9][13] - The drug has received QIDP designation and Fast Track status from the FDA, which may expedite its development process [10]