Pasithea Therapeutics announces FDA acceptance of IND application for PAS-004

Pasithea Therapeutics announced the Investigational New Drug Application clearance to proceed by the U.S. Federal Drug Administration to evaluate PAS-004, a macrocyclic MEK inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition. Pasithea expects to dose the first patient in the first quarter of 2024. The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients with preliminary early data expected as early as Q3 2024. Administered orally, PAS-004 is expected to be an once day or less frequent dose which may provide better compliance rates as well as superior efficacy. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials. Macrocycles exhibit unique drug-like profiles because of their cyclic structure, potentially improving bioavailability, binding affinity, and overall pharmacokinetics in comparison to acyclic counterparts.