Serina Therapeutics, Inc. has submitted a complete response to the FDA clinical hold letter for the SER-252 program.
The response includes detailed data on the proposed use of trehalose as an excipient and a revised protocol for the trial.
The Company is preparing for the initiation of the registrational Phase 1b study in Q1 2026, pending FDA feedback.
FDA Clinical Hold Response
Serina addressed FDA requests regarding the formulation excipient for SER-252.
Initiation of Phase 1b Study
Anticipated start of the single ascending dose phase in Q1 2026.
Global Site Start-Up
Continued activities in Australia and other regions for the registrational program.
- Serina's submission directly addresses the FDA's questions on trehalose, demonstrating a constructive response.
- Site start-up and regulatory activities support the global registrational program, aiming for the first-patient-in in Q1 2026.
Serina Therapeutics is actively working towards resolving the clinical hold to initiate the Phase 1b study and address unmet needs in advanced Parkinson's disease.