Core Insights - Pasithea Therapeutics Corp. is advancing its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor, for treating neurofibromatosis type 1 (NF1) and other cancer indications, with the external Safety Review Committee recommending progression to the next dose level of 30mg capsule without modifications [1][2] - The trial has shown no dose-limiting toxicities (DLTs) or rash in the initial 19 patients, which is significant as rash is a common adverse event associated with competitor MEK inhibitors [1][2] - The ongoing trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with advanced solid tumors driven by MAPK pathway mutations [2] Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system (CNS) disorders and RASopathies, with a team experienced in neuroscience, translational medicine, and drug development [3] - The company is working on new molecular entities for neurological disorders, including NF1, solid tumors, and amyotrophic lateral sclerosis (ALS) [3] Clinical Trial Details - The Phase 1 clinical trial is a multi-center, open-label, dose escalation study designed to assess PAS-004 in patients with documented RAS, NF1, or RAF mutations or those who have failed previous BRAF/MEK inhibition [2] - The trial has already identified patients for Cohort 6 and continues to observe substantial exposure levels of PAS-004, aiming to deliver relevant pERK inhibition below the no observed adverse effect levels (NOAEL) [2] - Additional safety, pharmacokinetic, and pharmacodynamic data are expected to be released in the coming weeks [2]
Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its Ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer