US-based Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced that Chinese Contract Research Organization (CRO) WuXi AppTec (SHA: 603259) will provide active pharmaceutical ingredient (API) manufacturing support for its lead candidate PAS-004 (formerly CIP-137401). Specifically, WuXi STA, a subsidiary of WuXi AppTec, will provide Good Manufacturing Practice (GMP) manufacturing to support the Investigational New Drug (IND) filing for PAS-004, expected in the second half of 2023.
PAS-004: Mechanism and Development
PAS-004 is a small molecule next-generation allosteric inhibitor of MEK 1/2 in the Ras-Raf-MEK-ERK signaling pathway. The molecule has been granted orphan drug status in the United States for the indication of neurofibromatosis Type 1 (NF1), which is the target for Phase I development expected to commence later this year. This partnership with WuXi AppTec underscores Pasithea’s commitment to advancing innovative therapies for rare diseases.
Future Outlook
With WuXi AppTec’s support, Pasithea is well-positioned to accelerate the development of PAS-004, addressing significant unmet needs in the treatment of NF1. The collaboration leverages WuXi AppTec’s expertise in API manufacturing to ensure robust and scalable production, paving the way for PAS-004’s clinical advancement.-Fineline Info & Tech
