-- Favorable Safety Profile Supports Long-Term Chronic Dosing: PAS-004 has been well-tolerated, with all treatment-related adverse events (TRAEs) being Grade 1 or 2, no observed cardiac or retinal treatment-related events, and low rates of rash and gastrointestinal toxicities -- Protocol Amendment Extends Dose Escalation to Higher Levels: Continued dose escalation using tablet formulation to explore 18mg, 24mg, 30mg, 40mg, and up to 52mg dose levels to further characterize safety, pharmacokinetics (PK), and early efficacy signals at higher doses -- Potential Best-in-Class MEK Inhibitor Profile Emerging: Interim PK and safety data at pharmacologically active doses support PAS-004 as a differentiated candidate with potential for long-term chronic dosing with favorable tolerability -- Pilot Food Effect Study Initiated: An optional pilot food effect assessment has been introduced to evaluate the impact of fed vs. fasted administration on PAS-004 pharmacokinetics, to optimize long-term dosing strategy MIAMI, June 30, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including the neurocutaneous manifestations of neurofibromatosis type 1 (NF1), today announced updated interim safety and clinical activity data from its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, including patients who have failed prior BRAF/MEK inhibitor treatment (NCT06299839).
