Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced the expansion of its Phase 1 clinical trial for PAS-004 into Eastern Europe, with new sites now open in Romania and Bulgaria. These sites are actively recruiting patients alongside the existing four sites in the United States.
The Phase 1 trial (NCT06299839) is a multi-center, open-label, dose-escalation study designed to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors. Eligible patients must have documented RAS, NF1, or RAF mutations, or have experienced failure with prior BRAF/MEK inhibition therapies. The trial employs a standard 3+3 dose-escalation design.
Patient Enrollment and Dosing
Pasithea has completed initial dosing of three patients in Cohort 4A, who received a 15mg capsule formulation of PAS-004. Patient recruitment is currently underway for Cohort 4B, which will evaluate a 4mg tablet formulation.
Collaboration with Arensia Exploratory Medicine
In Eastern Europe, Pasithea is collaborating with Arensia Exploratory Medicine, involving sites such as the Institute of Oncology Bucharest, Institute of Oncology Cluj-Napoca, and Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD.
Management Commentary
Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea, stated, “We are pleased to be working with Arensia in Eastern Europe, allowing PAS-004 to be tested in patients with tumor types more sensitive to single agent MEK treatment or patients who have previously failed first-generation MEK inhibitors.”
Anticipated Data Release
The company anticipates presenting interim safety and pharmacokinetic data from Cohorts 4A and 4B in the first quarter of 2025.
About PAS-004
PAS-004 is a next-generation macrocyclic MEK inhibitor being developed by Pasithea Therapeutics for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications. It is designed to selectively inhibit MEK, a key enzyme in the MAPK signaling pathway, which is often dysregulated in various cancers and RASopathies.
