Serina Therapeutics announced completion of sentinel dosing in Cohort 1 of its Phase 1b registrational trial evaluating SER-252 for advanced Parkinson’s disease.
The independent Safety Monitoring Committee completed an initial review of 72-hour safety and tolerability observations from the sentinel group and recommended continued dosing; additional patients are being dosed at sites in the United States and Australia, according to the company.
Serina now expects to complete Cohort 1 enrollment and dosing ahead of its prior guidance to finish by the end of the third quarter of 2026, subject to continued trial execution.
The randomized, double-blind, placebo-controlled study includes single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of 16; n=48) to evaluate safety, tolerability and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures including MDS-UPDRS motor scores and structured motor-state assessments.
Dose escalation is overseen by the Safety Monitoring Committee and the study plans to add sites in South Korea and Taiwan. The company claims SER-252, a POZ-apomorphine formulation designed for sustained apomorphine exposure via subcutaneous administration, could reduce the burden of infusion-based approaches.