Pasithea Therapeutics has added a new U.S. clinical‑trial site at the University of Alabama at Birmingham (UAB) for its Phase 1/1b open‑label study of PAS‑004 in adult patients with neurofibromatosis type 1 (NF1). The activation expands the trial’s global footprint to five sites, including locations in Australia and South Korea.
The study (NCT06961565) evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics of PAS‑004 across four dose levels—4 mg, 8 mg, 12 mg, and 18 mg—using a modified 3 + 3 design. Enrollment at the UAB site is expected to begin immediately, adding to the overall enrollment capacity of the trial.
PAS‑004 is a next‑generation macrocyclic oral MEK inhibitor that targets the MAPK pathway, which is implicated in NF1 and other RAS‑associated disorders. The company has previously announced the initiation of the NF1 Phase 1/1b study in May 2025 and has activated sites in South Korea.
In addition to the site activation, Pasithea will host the 2025 NF Caregivers Symposium at UAB on November 8, 2025, serving as the Platinum Sponsor. The symposium will bring together caregivers, clinicians, researchers, and advocates to discuss patient care and emerging research in NF1.
The addition of UAB, known for its NF1 expertise, is expected to accelerate patient recruitment and provide access to a broader patient population.
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