Pasithea Therapeutics Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients

Core Insights - Pasithea Therapeutics Corp. has initiated clinical trials for PAS-004, a next-generation macrocyclic MEK inhibitor, in South Korea targeting neurofibromatosis type 1 (NF1) patients with symptomatic plexiform neurofibromas [1][9] Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 participants [5] - The trial will be conducted at two sites in South Korea: ASAN Medical Centre and Severance Hospital, which are now actively recruiting participants [2][3] - The study consists of two parts: Part A focuses on dose escalation to identify the recommended Part B dose (RPBD), while Part B will evaluate the recommended phase 2 dose (RP2D) [6] Institutional Background - ASAN Medical Centre is the largest hospital in South Korea with 2,432 beds and a significant NF1 caseload, providing a strong research background for the trial [3] - Severance Hospital, one of the oldest and largest university hospitals in South Korea, has 2,437 beds and treats millions of outpatients annually, enhancing the trial's recruitment potential [4] Objectives of the Study - Primary objectives include assessing the safety and tolerability of PAS-004 over a 28-day treatment cycle and evaluating its preliminary efficacy on target plexiform neurofibromas [5] - Secondary objectives involve identifying the RPBD, characterizing the PK and PD profile, and evaluating the impact on quality of life (QOL) and associated symptoms [5][6]