Serina Therapeutics, a clinical-stage biotechnology company, received FDA feedback supporting advancing SER-252 in a registrational clinical study program for advanced Parkinson's disease under the 505(b)(2) NDA pathway.
The company plans to start U.S. enrollment in Q1 2026 and initiate patient dosing in Australia in Q4 2025.
SER-252 aims to provide continuous dopaminergic stimulation for advanced Parkinson's patients, enhancing daily function and reducing motor fluctuations.
FDA Support
FDA feedback supports advancing SER-252 in a registrational clinical study program under the 505(b)(2) NDA pathway.
Development Plan
Serina aims for a rigorous and capital-efficient development plan to streamline the NDA process for SER-252.
Pipeline Expansion
The company is advancing a pipeline of POZ-enabled small molecules following similar NDA pathways where appropriate.
- The FDA's support validates Serina's POZ Platform™ technology for drug optimization.
- Upcoming milestones include U.S. IND filing in Q4 2025, patient dosing in Australia, and U.S. enrollment in Q1 2026.
- The SER-252 study design focuses on safety, tolerability, pharmacokinetics, and efficacy in Parkinson's patients with motor fluctuations.
Serina's positive FDA feedback and upcoming regulatory milestones position SER-252 as a promising therapy for advanced Parkinson's disease, demonstrating the company's commitment to improving patients' lives through innovative treatments.