MIAMI, FL — September 16, 2025 — Leads & Copy — Pasithea Therapeutics Corp. (NASDAQ: KTTA) has activated two South Korean clinical trial sites for its Phase 1/1b open label study of PAS-004 in adult participants with neurofibromatosis type 1 (NF1). The study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in patients with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.
The South Korean sites, ASAN Medical Centre and Severance Hospital Yonsei University Health System, are now recruiting NF1 trial participants. Professor Lee Beom-Hee of Asan Medical Center expressed pleasure in partnering with Pasithea and noted their institution’s extensive NF1 caseload and research leadership. Dr. Tiago Reis Marques, CEO of Pasithea, believes the South Korean sites will play a pivotal role in the trial’s success, given their world-class facilities and the estimated 10,000 NF1 patients in South Korea.
The Phase 1/1b study (NCT06961565) aims to evaluate the safety and tolerability of PAS-004 over a 28-day treatment cycle. Secondary objectives include identifying the recommended Part B dose, characterizing the PK and PD profile, and evaluating the preliminary efficacy of PAS-004 on target PN volume, size, appearance, associated symptoms of cutaneous neurofibromas (CNs), and quality of life (QOL).
The trial will be conducted in two parts: a dose escalation phase (Part A) and an expansion phase (Part B). It will take place at five clinical trial sites in Australia, South Korea, and the U.S. Pasithea Therapeutics Corp. is focused on the research and development of PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases.
Pasithea Therapeutics Contact:
Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com
Source: Pasithea Therapeutics Corp.
