(RTTNews) - Biotechnology company Pasithea Therapeutics Corp. (KTTA) announced Wednesday receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) 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.
The company said it will begin dosing as early as the first quarter of 2024 following acceptance of the IND by the FDA.
PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies to support an IND application with the FDA that it plans to submit in the fourth quarter of 2023.
