Serina Therapeutics, a clinical-stage biotechnology company, has drawn the first $5 million tranche of a potential $20 million financing agreement to advance its registrational trial of SER-252 for advanced Parkinson’s disease, according to the company. Subsequent funding tranches are linked to specific development milestones, including patient enrollment in the clinical trial.
The company said that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration and received Human Research Ethics Committee approval in Australia. Serina remains on schedule to begin the registrational study in the fourth quarter of 2025, with first patient dosing expected by year-end.
The SER-252-1b trial is a randomized, double-blind, placebo-controlled Phase 1b study. It includes single-ascending-dose and multiple-ascending-dose cohorts in adults with Parkinson’s disease and motor fluctuations. The study is designed to assess safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory measures including motor scores and structured motor-state assessments. Dose escalation will be monitored by a Safety Review Committee.
SER-252, developed using Serina’s POZ Platform, is intended to provide continuous dopaminergic stimulation through single or twice-weekly subcutaneous injections. The therapy uses Enable Injections’ enFuse wearable delivery system to enhance patient convenience and reduce motor fluctuation severity, according to the company.
Serina Therapeutics is headquartered in Huntsville, Alabama, and develops a pipeline of drug candidates targeting neurological diseases and other indications.
