Pasithea Therapeutics Announces Activation of Clinical Trial Site at University of Alabama at Birmingham for Ongoing Phase 1/1b Trial of PAS-004 in Adult NF1 Patients

Core Insights - Pasithea Therapeutics Corp. has activated a new clinical trial site at the University of Alabama at Birmingham (UAB) for its Phase 1/1b study of PAS-004 in adult patients with neurofibromatosis type 1 (NF1) [1][2] - The company is also serving as a Platinum Sponsor for the 2025 NF Caregivers Symposium, emphasizing its commitment to the NF1 community [3] 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 patients with symptomatic and inoperable plexiform neurofibromas [2][4] - The trial will be conducted in two parts: Part A will involve dose escalation with up to 24 participants receiving one of four planned dose levels (4mg, 8mg, 12mg, 18mg) [5] - Part B will enroll approximately 24 participants to receive doses at the recommended phase 2 dose (RP2D) for up to six continuous 28-day treatment cycles [5][6] Objectives of the Study - Primary objectives include evaluating the safety and tolerability of PAS-004, identifying the recommended Part B dose, and assessing preliminary efficacy on target neurofibromas and quality of life [4][5] - Secondary objectives focus on the impact of PAS-004 on cutaneous neurofibromas and associated symptoms, as well as pain and function related to plexiform neurofibromas [4][5] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating RASopathies and MAPK pathway-driven tumors [7] - The company is currently conducting multiple clinical trials, including a Phase 1 trial in advanced cancer patients [7]