Pasithea Therapeutics Announces Enrollment of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients

Core Viewpoint - Pasithea Therapeutics Corp. has received a recommendation from the external Safety Review Committee to proceed with the Phase 1/1b clinical trial of PAS-004 for neurofibromatosis type 1 (NF1) without modifications, indicating positive safety data from initial cohorts [1][8]. Group 1: Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult participants with symptomatic and inoperable plexiform neurofibromas [3][4]. - 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][5]. - The study is being conducted at five clinical trial sites across Australia, South Korea, and the U.S. [5]. Group 2: Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor targeting RASopathies and MAPK pathway-driven tumors [6]. - The company is also conducting a Phase 1 clinical trial of PAS-004 in advanced cancer patients [6]. Group 3: Enrollment and Future Expectations - There is substantial enrollment demand for the trial, with the first three patients in Cohort 2 already enrolled [2]. - Initial interim clinical data from the first two cohorts is expected to be released in Q1 2026 [8].