Pasithea Therapeutics Announces Completion of Cohort 7 in Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients, with Positive Safety, Pharmacokinetic (PK), and Pharmacodynamic (PD) Data

Core Insights - Pasithea Therapeutics Corp. announced positive safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial for PAS-004, a macrocyclic oral MEK inhibitor targeting MAPK pathway-driven advanced solid tumors [1][2][8] Safety and Tolerability Results - Zero treatment-related adverse events were observed during the dose-limiting toxicity (DLT) period in Cohort 7 [1][6] - The Safety Review Committee recommended proceeding to the next dose level, Cohort 8 (45mg capsules), without modifications [1][6] Pharmacodynamics (PD) Results - PD data supports continuous suppression of the MAPK pathway throughout the 24-hour dosing cycle [1][2] - PAS-004 demonstrated an ability to inhibit phosphorylated extracellular signal-regulated kinase (pERK) at levels of 80% near Cmax and above 60% at Cmin [6] Pharmacokinetics (PK) Results - The PK profile showed linearity and dose-proportionality with a Cmax/Cmin ratio of less than 2 [1][6] - Achieved AUC of 6,690 ng·h/mL, Cmax of 313 ng/mL, and Cmin of 260 ng/mL [1][6] Company Overview - Pasithea is focused on developing PAS-004 for treating RASopathies, MAPK pathway-driven tumors, and other diseases, currently in Phase 1 clinical trials for advanced cancer and neurofibromatosis type 1 [8]