Serina Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND)$ application for SER-252, an investigational therapy for advanced Parkinson's disease. The clearance allows the company to proceed with regulatory and site-level activities to support the initiation of a planned Phase 1b registrational clinical study. The FDA has provided feedback supporting the proposed clinical trial design under a 505(b)(2) New Drug Application (NDA) pathway. Phase 1b clinical site start-up and regulatory activities in Australia are also underway as part of the global registrational program.
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