FDA Grants Fast Track Designation to Pasithea's PAS-004 for NF1-Associated Tumors

The U.S. Food and Drug Administration has granted Fast Track designation to Pasithea Therapeutics' drug candidate PAS-004 for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas causing significant morbidity. The designation facilitates development and expedites review of drugs addressing unmet medical needs in serious or life-threatening conditions.

Fast Track designation includes opportunities for frequent communications with FDA review teams throughout the product development process and rolling review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application. In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met.

"We appreciate the FDA's decision that PAS-004 meets the criteria for Fast Track designation for this indication," said the Chief Executive Officer of Pasithea. "The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity."

The company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-associated plexiform neurofibromas. The clinical trial identifier is NCT06961565.

Plexiform neurofibromas are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent of patients with NF1 will harbor plexiform neurofibromas, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

Pasithea describes PAS-004 as a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The company is also testing PAS-004 in a Phase 1 clinical trial in patients with advanced cancer under clinical trial identifier NCT06299839.