Pasithea Therapeutics Receives Positive SRC Recommendation for PAS-004 in Phase 1 Cancer Trial

Pasithea Therapeutics Corp., a clinical-stage biotechnology firm listed on NASDAQ, has announced significant progress in its development of PAS-004, a novel macrocyclic MEK inhibitor designed to treat neurofibromatosis type 1 (NF1) and other cancers. The company's external Safety Review Committee has recommended advancing to the fourth cohort of the clinical trial, escalating the dosage to a 15mg capsule without any modifications. This decision follows the observation that no dose-limiting toxicities (DLTs) or rashes have developed in the first nine patients treated with PAS-004.

The trial is now set to include an additional cohort, referred to as cohort 4b, which will involve three more patients and introduce a new formulation intended for commercial use. This step aims to further evaluate the safety and potential market readiness of PAS-004.

Dr. Tiago Reis Marques, the CEO of Pasithea, expressed satisfaction with the trial's progress, highlighting the absence of rash, a common adverse effect seen at low doses with other MEK inhibitors. This adverse event often leads to high discontinuation rates in actual clinical practice. He also emphasized the importance of testing the commercial formulation in the ongoing trial.

The Phase 1 clinical trial employs a multi-center, open-label, dose-escalation 3+3 study design. It aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial effectiveness of PAS-004 in patients with advanced solid tumors driven by the MAPK pathway, including documented RAS, NF1, or RAF mutations, or in patients who have not responded to BRAF/MEK inhibition therapy.

PAS-004 distinguishes itself from earlier MEK inhibitors primarily used for NF1 treatment, which require twice-daily dosing and have short half-lives of less than eight hours. PAS-004, on the other hand, has a significantly longer half-life of about 70 hours, potentially allowing for once-daily dosing and prolonged target inhibition. The pharmacokinetic profile of PAS-004 shows consistent plasma levels at steady-state, indicated by a low Cmax to Cmin ratio, which may reduce the risk of toxicity related to peak plasma concentrations. These attributes offer a strong justification for further clinical trials of PAS-004 for treating cutaneous and plexiform neurofibromas in NF1, as well as other cancers driven by MAPK pathway mutations.

Pasithea Therapeutics is a biotechnology company dedicated to developing innovative treatments for central nervous system (CNS) disorders and RASopathies. The company's team possesses extensive expertise in neuroscience, translational medicine, and drug development. Pasithea is focused on creating new molecular entities to treat neurological disorders, including NF1, solid tumors, and amyotrophic lateral sclerosis (ALS).

The company plans to provide ongoing updates as the clinical trial for PAS-004 progresses, aiming to bring a promising new treatment option to patients with NF1 and other related conditions. The trial's encouraging results so far suggest that PAS-004 could offer significant benefits over existing treatments, particularly in terms of safety and dosing convenience.