SOUTH SAN FRANCISCO, Calif. - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotechnology company, has announced the activation of four U.S. clinical trial sites for its Phase 1 study of PAS-004. The investigational drug, a macrocyclic MEK inhibitor, is being evaluated for its safety, dosage, biomarker data, and preliminary efficacy in treating neurofibromatosis type 1 (NF1) and other cancers.
The trial sites, located in Texas and Virginia, began enrolling patients following the U.S. Food and Drug Administration (FDA) approval of the Investigational New Drug (IND) application. The study focuses on patients with MAPK pathway-driven advanced solid tumors with specific mutations or those who have not responded to BRAF/MEK inhibition.
Pasithea aims to establish the safety and pharmacokinetics of PAS-004 to proceed with a Phase 2 trial for NF1 in both pediatric and adult patients. The company has partnered with Novotech as the clinical research organization (CRO) and NEXT Oncology for the Phase 1 trial. Dr. Anthony Tolcher M.D. and Dr. Ildefonso Rodriguez M.D. are leading the San Antonio, TX site.
The company also plans to open additional trial sites in Eastern Europe in the upcoming months, with interim data expected in the second half of 2024. PAS-004 is the first of its kind to enter human clinical trials and is believed to have an extended half-life, potentially leading to better compliance and efficacy in NF1 treatment.
PAS-004 is designed to inhibit MEK 1/2 in the MAPK signaling pathway, which when abnormally activated, can contribute to tumor growth and progression. Pasithea Therapeutics believes that PAS-004's macrocyclic structure may result in improved pharmacokinetic and tolerability profiles compared to existing FDA-approved MEK inhibitors. The drug has been granted orphan-drug designation by the FDA for NF1, which could provide seven years of marketing exclusivity upon approval.
This information is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. Pasithea Therapeutics has made no further comments beyond this release.
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