Pasithea Therapeutics completes cohort 7 in Phase 1 trial of PAS-004

Pasithea Therapeutics (KTTA) announced safety, PK and PD data from Cohort 7 in its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or in patients who have failed prior BRAF/MEK inhibition. PAS-004 has demonstrated in Cohort 7: Safety and Tolerability Results: PAS-004 was safe and well tolerated with no dose limiting toxicities, and no treatment-related adverse events observed during the DLT period. After reviewing cohort 7 data, the Safety Review Committee recommended to proceed to Cohort 8, 45mg capsules, without modification. Pharmacodynamics Results: At steady-state, individual patient plasma data showed PAS-004 inhibiting phosphorylated extracellular signal-regulated kinase at a level of 80% near Cmax. At steady-state, individual patient plasma data showed PAS-004 inhibiting pERK at a level above 60% at Cmin. Pharmacokinetics Results: Linear PK and dose-proportionality. PK curve with Cmax/Cmin ratio less than2. AUC: 6,690 ng*h/mL; Cmax: 313 ng/mL; Cmin: 260 ng/mL.