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

Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotechnology firm, is advancing its efforts in developing PAS-004, an innovative macrocyclic MEK inhibitor aimed at treating neurofibromatosis type 1 (NF1) and various cancer indications. Recently, the company announced that an independent Safety Review Committee has approved the continuation to cohort 5 of its Phase 1 clinical trial of PAS-004 in advanced cancer patients, involving the administration of a 22mg capsule without any alterations to the study protocol. This decision follows a thorough analysis of safety data from three participants in cohort 4A, who received a 15mg dose and exhibited no dose-limiting toxicities (DLTs). Additionally, no skin rashes, a common adverse effect associated with low doses of other MEK inhibitors, have been observed in any of the first 14 participants treated with PAS-004, whether in capsule or tablet form.

Dr. Tiago Reis Marques, CEO of Pasithea, expressed optimism about the safety profile of PAS-004, highlighting the significant exposure levels achieved with the drug. He emphasized the potential of PAS-004, with a half-life exceeding 60 hours, to transform the treatment landscape for patients with NF1 and inoperable plexiform neurofibromas. The company plans to unveil updated pharmacokinetic (PK) and pharmacodynamic (PD) data in the first quarter of 2025, further enlightening the medical community on the drug's efficacy and safety.

The ongoing Phase 1 trial is characterized by a multi-center, open-label, dose-escalation design employing a 3+3 study structure. It aims to assess the safety, tolerability, PK, PD, and initial efficacy of PAS-004 in individuals with advanced solid tumors driven by mutations in the MAPK pathway. Specifically, this includes patients with documented RAS, NF1, or RAF mutations, along with those who have not responded to prior BRAF/MEK inhibition treatments.

Pasithea Therapeutics is dedicated to the discovery, research, and development of novel therapies targeting central nervous system (CNS) disorders and RASopathies. The company boasts a team of seasoned experts specializing in neuroscience, translational medicine, and drug development. Their efforts are concentrated on creating new molecular entities designed to address a range of neurological disorders, such as Neurofibromatosis type 1 (NF1), solid tumors, and Amyotrophic Lateral Sclerosis (ALS).

Through these initiatives, Pasithea aims to contribute significantly to the field of biotechnology by providing innovative solutions for challenging medical conditions, emphasizing both safety and efficacy in their therapeutic approaches. As the Phase 1 trial progresses, the company remains committed to enhancing the understanding of PAS-004's potential benefits and strengthening its position in the realm of advanced cancer treatment.