Pasithea Therapeutics, a clinical-stage biotechnology company, has expanded its Phase 1 clinical trial of PAS-004, a next-generation MEK inhibitor, by opening three new sites in Eastern Europe. These new sites, located in Romania and Bulgaria, join four existing sites in the United States and are actively recruiting patients for the study, which is investigating PAS-004 as a potential treatment for neurofibromatosis type 1 (NF1) and other cancers. The company has also dosed the first three patients in Cohort 4A (15mg capsule) and is actively recruiting for Cohort 4B (4mg tablet), with interim safety and pharmacokinetic data expected in Q1 2025.
This expansion into Eastern Europe is strategically important for Pasithea. It broadens the patient pool, potentially accelerating recruitment and providing access to patients with tumor types that may be more responsive to single-agent MEK inhibitors or who have not responded to previous treatments. This approach allows for a more comprehensive assessment of PAS-004’s efficacy and safety profile across a wider range of patient demographics and disease characteristics, which is crucial for successful drug development.
The Phase 1 trial is designed as a multi-center, open-label, dose-escalation study (3+3 design). It aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PAS-004 in patients with advanced solid tumors driven by the MAPK pathway. These patients will have documented RAS, NF1, or RAF mutations, or will have previously failed BRAF/MEK inhibitor treatment. The addition of new sites and the ongoing dosing of patients in Cohort 4 demonstrate Pasithea’s commitment to advancing the clinical development of PAS-004.
The expansion of the clinical trial and the anticipated release of interim data in Q1 2025 represent important milestones for Pasithea. These developments could significantly impact the future trajectory of PAS-004, potentially leading to faster clinical development and ultimately providing a much-needed new treatment option for patients with NF1 and other cancers. The data from these cohorts will be key in determining the optimal dose and informing the design of future clinical trials, potentially accelerating the path toward regulatory approval.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
