Serina Therapeutics has enrolled its first patient in a Phase 1b registrational trial evaluating SER-252, an investigational apomorphine-based therapy designed for patients with advanced Parkinson's disease. The trial, which commenced in Australia, will assess the drug candidate's safety profile, tolerability, pharmacokinetic properties, and preliminary efficacy in the target patient population.
The company has secured FDA alignment on its 505(b)(2) regulatory pathway for the new drug application, positioning SER-252 within an established approval framework that references previously approved apomorphine formulations. This regulatory strategy may facilitate a more streamlined development timeline compared to traditional 505(b)(1) pathways.
Serina Therapeutics maintains its guidance for first patient dosing to occur during the first quarter of 2026. The advancement represents a key milestone in the company's clinical development program for addressing motor complications in advanced Parkinson's disease patients.