Pasithea says SRC recommends Phase 1 PAS-004 trial escalate to next dose level

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 6, 30mg capsule, without modification. This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose limiting toxicities. In addition, no rash has been observed to date during the DLT period in any of the first 19 patients in either capsule or tablet formulation of PAS-004. Rash is a common adverse event that is observed at low doses with competitor MEK inhibitors and may lead to the 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