Pasithea Therapeutics Announces FDA Acceptance of IND Application for PAS-004 in Advanced Cancer Patients

Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced the U.S. Federal Drug Administration (FDA) clearance of its Investigational New Drug Application (IND) to proceed with the evaluation of PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors. These patients have a documented RAS, RAF or NF1 mutation or have failed BRAF/MEK inhibition. The company plans to dose the first patient in the first quarter of 2024.

The dose escalation study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients. Preliminary early data is anticipated as early as Q3 2024.

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea, highlighted the significance of the FDA's notification, marking a pivotal step in the company's evolution into a clinical stage entity. PAS-004, administered orally, is expected to offer a once-a-day or less frequent dosing schedule, potentially improving compliance and efficacy. It is the first macrocyclic MEK inhibitor to enter human clinical trials, with its cyclic structure believed to enhance bioavailability, binding affinity, and overall pharmacokinetics compared to acyclic counterparts.

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, targeting the MAPK signaling pathway implicated in various diseases. The inhibitor blocks the phosphorylation of ERK, leading to cell death and tumor growth inhibition. Unlike existing FDA-approved MEK inhibitors, PAS-004's macrocyclic nature may offer improved pharmacokinetic and safety profiles, with potential for stronger and more durable response rates and efficacy. The compound has completed preclinical testing and animal toxicology studies and has received orphan-drug designation from the FDA for the treatment of NF1.

Pasithea Therapeutics Corp. is dedicated to discovering, researching, and developing innovative treatments for central nervous system (CNS) disorders and RASopathies, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS).