India, Nov. 3 -- Pasithea Therapeutics Corp. (KTTA) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PAS-004 to treat neurofibromatosis type 1 (NF1)-associated cutaneous neurofibromas (cNF).
Cutaneous neurofibromas are benign tumors that develop in or beneath the skin and affect more than 95% of people with NF1.
They can cause disfigurement and significantly affect patients' daily activities and quality of life. There are currently no FDA-approved systemic therapies for NF1-associated cNF.
The FDA clearance allows Pasithea to proceed with a randomized, placebo-controlled Phase 2 clinical trial of PAS-004 in patients with NF1-associated cNF in the United States.
The...