Pasithea reports early PAS-004 trial data

• Pasithea Therapeutics released positive interim Phase 1 data for PAS-004 in advanced MAPK-driven solid tumors.
• The drug showed disease stabilization beyond six months in several heavily pretreated patients.
• The study is expanding dose escalation and adding a food-effect evaluation for tablet dosing.

Pasithea Therapeutics (NASDAQ:KTTA) reported positive interim Phase 1 clinical trial results for PAS-004, an oral MEK inhibitor being tested in advanced MAPK pathway-driven solid tumors, including patients previously treated with MEK and BRAF inhibitors.

The study included 34 heavily pretreated patients and showed a favorable safety profile along with cases of durable disease stabilization lasting more than six months.

“The data support continued development of PAS-004 as a once-daily oral therapy,” Pasithea Therapeutics said, citing pharmacokinetic results that support chronic dosing.

The company said a protocol amendment will extend dose escalation using a tablet formulation up to 52 mg and introduce a pilot study to assess food effects on drug absorption.

Pasithea said PAS-004 is being developed for tumors driven by MAPK pathway alterations, a key signaling pathway in several cancer types.

The company also said ongoing dose escalation and additional studies will help refine safety and dosing for later-stage clinical trials.