Serina Therapeutics has completed sentinel dosing in Cohort 1 of its ongoing Phase Ib registrational trial assessing SER-252 in adults with advanced Parkinson’s disease.
The placebo-controlled, randomised, double-blind trial is being conducted at sites in Australia and the US, with plans to expand into South Korea and Taiwan during later study stages.
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The Independent Safety Monitoring Committee reviewed initial safety and tolerability data collected over 72 hours following sentinel dosing and recommended that dosing continue in the remainder of Cohort 1. Dosing of additional participants in this cohort is underway.
Serina Therapeutics has updated its expected timeline for Cohort 1, indicating that completion of enrolment and dosing is anticipated ahead of the previously guided end of the third quarter of 2026, subject to continued successful trial execution.
The SER-252-1b study includes single-ascending-dose (five cohorts of eight participants) and multiple-ascending-dose components (up to three cohorts of 16 participants).
The trial aims to further evaluate the safety, tolerability and pharmacokinetics of subcutaneous SER-252 compared to placebo, with exploratory measures such as Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor scores and structured motor-state assessments.
Dose escalation and trial conduct are overseen by the Safety Monitoring Committee.
SER-252 is an investigational therapy that uses Serina Therapeutics’ POZ Platform, which is based on poly(2-oxazoline) polymer technology.
This platform is intended to offer controlled drug loading and release, aiming to address challenges seen with existing therapeutics, particularly pharmacokinetic limitations.
Serina Therapeutics CEO Steve Ledger said: “Completion of sentinel dosing represents an important early operational milestone in the Phase Ib registrational study of SER-252. We are encouraged by the pace of execution across our clinical sites and remain focused on advancing SER-252 through Cohort 1 in a disciplined, data-driven manner.
“SER-252 is designed to address a significant need for patients with advanced Parkinson’s disease by providing sustained apomorphine exposure through convenient subcutaneous administration, with the goal of reducing the burden associated with currently available infusion-based approaches.”
