Pasithea Therapeutics has activated two key clinical trial sites in South Korea for its Phase 1/1b study of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial will avail the safety, tolerability, and pharmacokinetics of PAS-004 in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.
The activated sites include ASAN Medical Center and Severance Hospital, which together have access to around 10,000 NF1 patients in South Korea. Professor Lee Beom-Hee from ASAN Medical Center, home to the largest NF1 patient group in the country, will lead the trial at their facility. PAS-004 has demonstrated a unique pharmacokinetic profile as well as offers a more convenient dosing schedule compared to current treatments.
Its key features include:
- Available to approximately 10,000 NF1 patients in South Korea with this world-class facilities
- PAS-004 demonstrates improved pharmacokinetic profile and more convenient dosing regimen
- Partnership with South Korea's largest hospital and leading NF1 research institution
This trial will evaluate key endpoints such as safety, tolerability, pharmacokinetics, and pharmacodynamics standard but crucial measures in early-phase drug development. Expanding to South Korea adds a multinational factor to the study, improving the abundance of the data across diverse patient populations.
For a small biotech with a market cap under USD 50 million, this expansion holds a smart use of resources by leveraging South Korea’s advanced medical infrastructure to help accelerate the development timeline.
