Curanex Achieves Key Preclinical Milestone with Favorable Toxicology Profile at Maximum Dose, Advancing Toward IND Submission

Core Viewpoint - Curanex Pharmaceuticals has successfully completed a dose-range finding toxicology study for its lead botanical drug candidate, Phyto-N, which shows no toxicological significance at maximum feasible doses, allowing progression to GLP toxicology studies for an IND application targeted for Q4 2026 [1][5][6] Group 1: Study Results - The dose-range finding toxicology study involved administering Phyto-N twice daily for 28 days in both rats and dogs, with the highest dose being approximately six times the proposed clinical oral dose in dogs and four times in rats [3] - Comprehensive safety assessments were conducted, including hematology, coagulation parameters, serum biochemistry, and organ examinations, with no treatment-related adverse findings observed [4] Group 2: Historical Context and Development Plans - Phyto-N has over 30 years of established human use in China, administered at a daily dose of 30 g for inflammatory diseases, demonstrating a favorable tolerability profile [2][9] - The company is conducting a full suite of nonclinical studies required by the FDA, including GLP toxicology and pharmacokinetics, to support its IND application [2][10] - Phase 1 clinical development is planned to initiate in Australia in Q4 2026, contingent on the completion of required studies and regulatory clearance [9][10] Group 3: Company Overview - Curanex Pharmaceuticals is a development-stage company focused on botanical drugs for inflammatory diseases, with Phyto-N as its lead candidate targeting moderate-to-severe ulcerative colitis, a condition affecting approximately 5 million patients globally [7][10] - Phyto-N is derived from a single plant species with demonstrated anti-inflammatory properties and has been validated in animal models for multiple inflammatory diseases [8][10]