Pasithea Therapeutics completes PAS-004 chronic toxicity studies

Pasithea Therapeutics announced the completion of long-term chronic toxicity studies in both rats and dogs with its lead candidate PAS-004, currently being investigated in a Phase 1 clinical trial in advanced cancer patients. Results show that once daily treatment with PAS-004 for 6-months in rats and 9-months in dogs at different dose levels confirms the observations of prior 28-day toxicity studies and indicates a similar safety profile following long-term dosing in both species. Further, the 9-month study in dogs established 0.5 mg/kg as the no adverse effect level in dogs, the most sensitive species. PAS-004 demonstrated a consistent safety profile at doses that correlate with significant pathway engagement and will likely produce significant pERK reduction when dosed below the NOAEL. Completion of this milestone is planned to support chronic patient dosing. For the chronic toxicity studies, PAS-004 was administered in crystalline form and demonstrated a similar adverse event profile and equivalent NOAEL in dogs as compared to the original amorphous formulation. The Company is using a crystalline form of PAS-004 in its human clinical trials.