Pasithea Therapeutics announces initial data from Phase 1 trial of PAS-004

Pasithea Therapeutics announced safety, tolerability, pharmacokinetic and preliminary efficacy data from the first 2 cohorts of patients in its Phase 1 clinical trial of PAS-004, being conducted at four clinical sites in the United States. The Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. Pharmacokinetics: Plasma exposure increased with an increase in dose and linear PK is observed; Long half-life of approximately 70 hours will allow for once daily dosing or longer intervals; Prolonged systemic exposure with minimal fluctuation in PAS-004 plasma concentration at steady state indicates a potential to achieve constant target inhibition. Safety: No treatment-related adverse events or dose limiting toxicities observed to date