Pasithea Therapeutics Completes PAS-004 Chronic Toxicity Studies

Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotechnology firm, announced the completion of long-term chronic toxicity studies for its lead candidate, PAS-004. The studies, conducted in rats and dogs, yielded promising results that support the ongoing Phase 1 clinical trial for advanced cancer patients.

The studies involved administering PAS-004 daily over six months in rats and nine months in dogs at various dosage levels. The findings confirmed the safety profile observed in previous 28-day toxicity studies. Specifically, the nine-month study in dogs identified 0.5 mg/kg as the no adverse effect level (NOAEL), highlighting the drug’s safety at doses that correlate with significant pathway engagement. This milestone is crucial for supporting chronic patient dosing.

In these chronic toxicity studies, PAS-004 was administered in crystalline form. The results showed a consistent adverse event profile and equivalent NOAEL in dogs compared to the original amorphous formulation. The company plans to use the crystalline form of PAS-004 in its human clinical trials.

Dr. Tiago Reis Marques, CEO of Pasithea, stated, "We believe sustained suppression of the Mitogen Associated Protein kinase (MAPK) pathway over a prolonged period will enhance efficacy and offer a more manageable side effect profile compared to other MEK inhibitors. The results from these long-term chronic toxicity studies underline PAS-004’s potential as a best-in-class MEK inhibitor. We look forward to sharing additional data, including initial interim pharmacokinetic (PK) and pharmacodynamic (PD) data from our first-in-human Phase 1 clinical study later this quarter."

Pasithea Therapeutics Corp. is dedicated to the development of innovative treatments for central nervous system (CNS) disorders and RASopathies. The company is advancing new molecular entities for the treatment of neurological disorders such as Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS). Their team comprises experts in neuroscience, translational medicine, and drug development, working together to address these challenging conditions.