Serina Therapeutics announced that feedback from the U.S. Food and Drug Administration supports advancing its investigational therapy SER-252 (POZ-apomorphine) into a registrational clinical study program for advanced Parkinson’s disease via the 505(b)(2) New Drug Application pathway, according to the company.
The company said that officials at a recent Type B meeting agreed that SER-252’s initial Phase 1b trial can be designed as part of a broader registrational program, provided it meets standard clinical and nonclinical requirements and that documentation is finalized at the time of the Investigational New Drug application. Serina plans to include a pharmacokinetic bridging component to an approved apomorphine product in line with the 505(b)(2) strategy.
The SER-252-1b study is described by the company as a randomized, double-blind, placebo-controlled Phase 1b trial in adults with Parkinson’s disease experiencing motor fluctuations. It will have single-ascending-dose cohorts (five cohorts of eight, totalling 40 participants) and multiple-ascending-dose cohorts (up to three cohorts of 16, totalling 48 participants), designed to evaluate safety, tolerability and pharmacokinetics. Exploratory efficacy measures will include MDS-UPDRS motor scores and structured motor-state assessments. The trial will be conducted across sites in the U.S. and Australia, with dose escalation overseen by a Safety Review Committee.
Regarding regulatory milestones, Serina said it plans to submit its U.S. IND application in the fourth quarter of 2025, incorporating the FDA’s recommendations. In parallel, the company expects to begin dosing patients in Australia during that same quarter as part of its global registrational program. Subject to IND clearance, U.S. enrollment is anticipated to begin in the first quarter of 2026.
SER-252 is an investigational apomorphine therapy developed using Serina’s proprietary POZ Platform. It is designed to provide continuous dopaminergic stimulation via single- or twice-weekly subcutaneous injection and is delivered with the enFuse™ wearable drug delivery system developed in partnership with Enable Injections.
Serina said that this FDA feedback provides early validation for its POZ platform, which aims to optimize the delivery and pharmacokinetics of well-known therapies, and that the company is advancing a pipeline of POZ-enabled small molecules that may follow similar regulatory paths.
