Pasithea Therapeutics announces initiation of Phase 1/1b study of PAS-004

Pasithea Therapeutics (KTTA) announced initiation of its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PAS-004, in adult participants with neurofibromatosis type 1 with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The study will also assess preliminary anti-tumor activity and help determine a recommended dose for subsequent Phase 2 trials. Exploratory objectives include assessing the effects of PAS-004 on cutaneous neurofibromas. The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in Q2 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months.