Core Viewpoint - Pasithea Therapeutics Corp. has successfully completed long-term chronic toxicity studies for its lead candidate PAS-004, a macrocyclic MEK inhibitor, which is currently in a Phase 1 clinical trial for advanced cancer patients [1][2]. Group 1: Study Results - The long-term studies showed that daily treatment with PAS-004 for 6 months in rats and 9 months in dogs confirmed previous 28-day toxicity study results, indicating a similar safety profile across both species [2]. - The 9-month study in dogs established 0.5 mg/kg as the no adverse effect level (NOAEL), which is significant for determining safe dosing in future studies [2]. - PAS-004 demonstrated a consistent safety profile at doses that correlate with significant pathway engagement, suggesting potential for significant pERK reduction when dosed below the NOAEL [2]. Group 2: Formulation and Administration - PAS-004 was administered in crystalline form during chronic toxicity studies, showing a similar adverse event profile and equivalent NOAEL in dogs compared to the original amorphous formulation [3]. - The company is utilizing the crystalline form of PAS-004 in its human clinical trials, which may enhance the drug's efficacy and safety [3]. Group 3: Future Outlook - The company believes that sustained MAPK pathway suppression over a prolonged period will lead to enhanced efficacy with a more manageable side effect profile compared to other MEK inhibitors [4]. - Additional data on PAS-004, including initial interim pharmacokinetic and pharmacodynamic data from the Phase 1 clinical study, is expected to be shared later this quarter [4]. Group 4: Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system disorders and RASopathies, with a team experienced in neuroscience, translational medicine, and drug development [5].
Pasithea Therapeutics Announces Successful Completion of PAS-004 Chronic Toxicity Studies