Serina Therapeutics, Inc. announced on September 9, 2026, that the Independent Safety Monitoring Committee has completed a blinded review of Cohort 1 in the company's Phase 1b registrational study of SER-252. The committee recommended that the study advance to Cohort 2 following the review of safety and tolerability data.
Cohort 1 evaluated the lowest dose level in the single-ascending-dose portion of the study. The Company reported that blinded observations included a pharmacokinetic profile consistent with sustained apomorphine exposure, which is the intended effect of the drug. Additionally, the data showed sustained periods of improvement in motor function in individual patients on exploratory clinical measures.
The study enrolled eight patients with Parkinson’s disease and motor fluctuations. Patients were randomized 3:1 to receive a single dose of SER-252 or placebo. The study is designed to evaluate safety, tolerability, and pharmacokinetics, with exploratory clinical measures including MDS-UPDRS motor scores.
Serina Therapeutics expects to report topline data from the single-ascending-dose portion of the study in the first half of 2027. The registrational study is a randomized, double-blind, placebo-controlled trial with sites in the U.S., Australia, South Korea, and Taiwan.
