Curanex Completes Toxicology Study for Phyto-N
Curanex Pharmaceuticals announced the successful completion of a dose-range finding toxicology study of its lead botanical drug candidate, Phyto-N, conducted in Sprague-Dawley rats and dogs. The study evaluated repeat-dose oral tolerability over 28 days and is designed to inform dose selection and study design for the Company's subsequent Good Laboratory Practice-compliant toxicology studies required for its planned Investigational New Drug, or IND, application, which the Company targets to submit in the Q4. Phyto-N has an established human use history in China spanning more than 30 years, having been administered at a daily dose of 30 g for the treatment of inflammatory diseases in thousands of patients, with a favorable tolerability profile. To bring Phyto-N into clinical development in the U.S., the Company is conducting the full suite of nonclinical studies required by the FDA to support an IND application, including GLP toxicology, pharmacokinetics, and Chemistry, Manufacturing and Controls, or CMC, work. Phyto-N was administered twice daily by oral gavage for 28 consecutive days across multiple dose levels in both rats and dogs. In each species, the maximum feasible dose was established based on the maximum achievable drug concentration and the maximum daily gavage volume. The highest dose tested was approximately six times the proposed clinical oral dose in dogs and approximately four times in rats. All animals underwent comprehensive safety assessments throughout the study period, including hematology, coagulation parameters, serum biochemistry, and gross and histopathological examination of major organs. No treatment-related adverse findings of toxicological significance were observed at any dose level in either species. These results are consistent with Phyto-N's safety profile accumulated over more than 30 years of human use in China, and provide a sound scientific basis for proceeding to the formal GLP toxicology program.
