Pasithea Completes Cohort 2 Enrollment and Initial Dosing after Positive Safety Review for PAS-004 in Phase 1 Trial

Pasithea Therapeutics Corp. (NASDAQ: KTTA) made a significant announcement regarding their Phase 1 clinical trial of PAS-004, a new macrocyclic MEK inhibitor aimed at treating neurofibromatosis type 1 (NF1) and other related conditions. The independent Safety Review Committee (SRC) has completed its review of the initial data from the first dose cohort (2mg) in the ongoing trial involving patients with advanced solid tumors driven by MAPK pathway mutations, such as RAS, NF1, or RAF, or those who have not responded to BRAF/MEK inhibition.

The SRC's assessment indicated no dose-limiting toxicities or significant adverse events, leading them to recommend proceeding to the next dose level of 4mg. Subsequently, Pasithea has already enrolled and administered the initial dosing for the second cohort of three patients.

Dr. Tiago Reis Marques, the CEO of Pasithea, expressed satisfaction with the swift progress in the trial, noting the rapid enrollment and dosing of the second cohort following the positive SRC recommendation. He emphasized the company's commitment to advancing PAS-004 as a potential treatment for various solid tumors and NF1-related neurofibromas. Pasithea aims to disclose initial safety and pharmacokinetic data by the third quarter of 2024.

The Phase 1 trial is a multicenter, open-label study focusing on the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004. The primary goal is to evaluate the drug's safety and tolerability, while secondary objectives include assessing PK and PD parameters, preliminary anti-cancer efficacy, and establishing the recommended Phase 2 doses.

Pasithea Therapeutics Corp. is dedicated to developing innovative treatments for central nervous system (CNS) disorders and RASopathies. Their expertise spans neuroscience, translational medicine, and drug development, targeting conditions such as Neurofibromatosis type 1 (NF1), solid tumors, and Amyotrophic Lateral Sclerosis (ALS).

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