Pasithea Therapeutics Corp. ((KTTA)) announced an update on their ongoing clinical study.
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Pasithea Therapeutics Corp. is conducting a clinical trial titled ‘A Phase 1/1b Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PAS-004, a MAPK/ERK Kinase 1/2 (MEK 1/2) Inhibitor, in Adult Participants With Neurofibromatosis Type 1 (NF1) With Symptomatic and Inoperable, Incompletely Resected, or Recurrent Plexiform Neurofibromas.’ The study aims to evaluate the safety and side effects of PAS-004 in adults with NF1-related plexiform neurofibromas, a condition with limited treatment options.
The intervention being tested is PAS-004, a MEK 1/2 inhibitor, administered orally in tablet form. It is designed to target and manage symptoms associated with plexiform neurofibromas in NF1 patients.
This interventional study follows a non-randomized, sequential model with no masking, focusing on treatment. It involves two parts: Part A with dose escalation and Part B with two dose levels selected based on Part A results.
The study began on April 11, 2025, with a primary completion date yet to be determined. The latest update was submitted on September 18, 2025, indicating ongoing recruitment.
The study’s progress could influence Pasithea Therapeutics’ stock performance, as successful results may enhance investor confidence and position the company favorably against competitors in the NF1 treatment market.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.