Pasithea announces Safety Review Committee recommendation

Pasithea Therapeutics (KTTA) announced that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification. This recommendation was based on the review of the safety data from three patients in cohort 4A and the absence of any dose limiting toxicities, or DLT’s. In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule or tablet formulation. Rash is a common adverse event, or AE, that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice. The ongoing 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.