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

-- PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials --

-- Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 –

-- Initial readout expected as early as Q3 2024 –

SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) --  Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition. Pasithea expects to dose the first patient in the first quarter of 2024.

The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients with preliminary early data expected as early as Q3 2024.

“Receiving a study may proceed notification from the US FDA is a significant milestone in Pasithea’s maturation into a clinical stage company developing PAS-004 as a potential best-in-class next generation MEK inhibitor and demonstrates our ability to execute on our objectives,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “We believe PAS-004 has the potential to improve clinical responses in cancer patients as a monotherapy as well as provide a more tolerable and better dosing profile. After we have established a preliminary recommended phase 2 dose, we will use this information to bridge to dosing for Neurofibromatosis type 1 patients. We look forward to working with our clinical partners to start this study in the United States and Eastern Europe shortly.”

Administered orally, PAS-004 is expected to be an once day or less frequent dose which may provide better compliance rates as well as superior efficacy. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials. Macrocycles exhibit unique drug-like profiles because of their cyclic structure, potentially improving bioavailability, binding affinity, and overall pharmacokinetics in comparison to acyclic counterparts.