Pasithea Therapeutics (NASDAQ: KTTA) announced that the Safety Review Committee (SRC) has recommended 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 (NF1) should proceed to Cohort 2, 8mg tablet, without modification.
According to Pasithea, the recommendation was based on the review of the safety data from three patients from Cohort 1 and the absence of any dose limiting toxicities. The company expects initial interim clinical data from the first two cohorts in Q1 2026.
Dr. Tiago Reis Marques, CEO of Pasithea, commented, “We are seeing substantial enrollment demand and have already enrolled the first three Cohort 2 patients.”
The study is to be conducted at five clinical trial sites in Australia, South Korea, and the U.S.
