Pasithea Therapeutics announces outcome of pre-IND meeting for PAS-004

Pasithea Therapeutics announced receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration regarding clinical development plan for PAS-004. The FDA’s positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers. PAS-004 was granted orphan drug designation for the treatment of NF1 in November 2020. “We are pleased with our PAS-004 Pre-IND meeting minutes which guide us to dose patients who will benefit from treatment. We are excited to begin testing PAS-004 in a first-in-human Phase 1 dose escalation trial in advanced solid tumor patients harboring RAS, RAF and NF1 mutations including KRAS, NRAS, BRAF and NF1 mutations, who have not responded or recurred following treatment with available therapies as early as the first quarter of 2024 following acceptance of the IND by the FDA”, stated Dr. Tiago Reis Marques, CEO.