Approach

Pasithea Therapeutics is taking a thoughtful and methodical approach to the clinical development of PAS-004, with a focus on generating strong safety, pharmacokinetic, and early efficacy data as the program advances.

PAS-004 was designed as a next-generation macrocyclic oral MEK inhibitor intended to overcome some of the limitations seen with earlier MEK inhibitors, including issues related to tolerability and inconsistent drug exposure. The Company’s ongoing clinical studies are evaluating PAS-004 across multiple dose levels and tumor types, while also exploring its potential in NF1-associated plexiform neurofibromas and other MAPK pathway-driven diseases. Pasithea is working with leading clinical centers internationally to advance the program efficiently while maintaining a strong emphasis on patient safety, consistent target engagement, and long-term therapeutic potential.

Strategy

Our mission is to develop innovative therapies that address areas of high unmet medical need, initially in RASopathies for NF1. Key elements include:

Expand and complete our first-in-human clinical trial of PAS-004 in advanced cancer patients
Complete our advance Phase 1/1b clinical trial of PAS-004 for adult NF1-PN patients
Complete key regulatory-required studies of PAS-004 prior to initiating registrational trials
Expand utility of PAS-004 for other indications
Expand formulation development for PAS-004
Maximize the potential of PAS-004 utilizing investigator-initiated trials