Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients

Core Insights - Pasithea Therapeutics Corp. has completed enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) [1][2] Group 1: Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety and tolerability of PAS-004 in adult NF1 patients with symptomatic and inoperable plexiform neurofibromas [3] - The trial consists of two parts: Part A will identify the recommended Part B dose (RPBD) through a modified 3+3 design, while Part B will determine the recommended phase 2 dose (RP2D) [4] - The study will be conducted at five clinical trial sites across Australia, South Korea, and the U.S. [5] Group 2: Drug Profile and Advantages - PAS-004 is designed as a once-daily dosed MEK inhibitor, potentially improving patient compliance compared to current FDA-approved therapies that require twice-daily dosing [2] - The primary objective of the trial includes evaluating the preliminary efficacy of PAS-004 on target neurofibroma volume and associated symptoms [3] - Initial safety data from ongoing trials in advanced cancer patients have been encouraging, leading to optimism about PAS-004's potential for NF1 patients [2][6]