FDA clears Pasithea Therapeutics IND for Phase 2 trial of oral MEK inhibitor PAS‑004 in NF1 skin tumors
Pasithea Therapeutics announced that the U.S. Food and Drug Administration approved its Investigational New Drug application, allowing a randomized, placebo‑controlled Phase 2 study of PAS‑004 in patients with neurofibromatosis type 1‑associated cutaneous neurofibromas. The oral macrocyclic MEK inhibitor will be dosed once daily and the trial will be run in the United States under FDA oversight. Pasithea estimates that more than 80,000 U.S. patients have moderate‑to‑severe disease, and the company is also testing the drug in other NF1 and cancer programs.
Why it matters
The clearance enables Pasithea to begin enrolling patients, moving the candidate toward potential regulatory approval for a condition with no approved systemic therapy. Successful trial results could expand the company’s market opportunity and affect the valuation of KTTA.
Key facts
- 1The FDA approved Pasithea’s IND for a Phase 2 trial of PAS‑004 in NF1 cutaneous neurofibromas. investing.com
- 2The study will be randomized, placebo‑controlled and conducted in the United States under FDA supervision. rttnews.com
- 3PAS‑004 is an oral macrocyclic MEK inhibitor intended for once‑daily dosing. investing.com
- 4Pasithea estimates that more than 80,000 U.S. patients have moderate‑to‑severe NF1‑associated cutaneous neurofibromas. investing.com
- 5KTTA shares were up 8.67% to $0.39 after the announcement. rttnews.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.