Pasithea Therapeutics completes GMP manufacturing for PAS-004

Pasithea Therapeutics has completed manufacturing of GMP-compliant Phase 1 clinical supplies of the active pharmaceutical ingredient of its lead product candidate PAS-004, a next-generation macrocyclic MEK Inhibitor. GMP-compliant manufacturing of API was the final step needed to support the Investigational New Drug application that the Company expects to file with the U.S. Food and Drug Administration in the second half of 2023. The Company intends to utilize this supply of PAS-004 for its upcoming Phase I clinical trial. Following the anticipated submission of the IND application with the FDA, Pasithea plans to initiate a Phase 1 clinical trial in healthy volunteers by the end of 2023 with clinical results, including pharmacokinetic, pharmacodynamic and safety data, anticipated in the first half of 2024.