Core Insights - Pasithea Therapeutics Corp. has initiated a Phase 1/1b clinical trial for PAS-004, a macrocyclic MEK inhibitor, targeting adult patients with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas, with the first patient expected to be dosed in Q2 2025 [1][4] Group 1: Clinical Trial Details - The trial aims to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in adult NF1 patients [1][5] - The first clinical trial site is located at the Royal North Shore Hospital in Sydney, Australia, with additional sites planned in Australia, South Korea, and the United States [2][6] - The study will be conducted in two parts, with Part A focusing on dose exploration and Part B on determining the recommended phase 2 dose (RP2D) [8][9] Group 2: Financial and Operational Aspects - Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for the trial and anticipates eligibility for an Australian R&D Tax Incentive, which could provide a cash refund of up to 48.5% of eligible trial costs [3][6] - The company is funded to produce initial interim patient data in NF1 following recent financing activities, including the exercise of certain warrants [4] Group 3: Expert Commentary - Dr. Rebecca Brown, a member of Pasithea's Scientific Advisory Board, expressed optimism about the safety profile of PAS-004 based on previous data from advanced cancer patients and highlighted the importance of patient compliance due to the once-daily dosing regimen [4] - Dr. Tiago Reis Marques, CEO of Pasithea, emphasized the significance of this trial as a milestone for both the company and patients with NF1-related plexiform neurofibromas [4]
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site