Serina Therapeutics, Huntsville, Ala., July 23, 2026
Serina Therapeutics announced the successful completion of enrollment and dosing in Cohort 1 of its ongoing Phase 1b registrational clinical trial evaluating SER-252 for patients with advanced Parkinson’s disease. The company confirmed that all eight patients in the first cohort were enrolled and treated across clinical sites in the United States and Australia, achieving the milestone ahead of its previously announced guidance to complete the cohort by the end of the third quarter of 2026. The early completion highlights strong operational execution by the study team and participating research centers while marking another important step in the development of SER-252, an investigational therapy designed to provide continuous dopaminergic stimulation (CDS) through Serina’s proprietary POZ Platform™. The company stated that the next phase of the program will depend on the outcome of an independent safety review before advancing to higher-dose cohorts.
Independent Safety Review to Guide Next Dose Escalation
Following the completion of dosing in Cohort 1, an Independent Safety Monitoring Committee (SMC) will conduct a blinded evaluation of safety and tolerability data in accordance with the study protocol. The committee’s assessment will determine whether the clinical program can safely advance to the next dose-escalation stage. According to Chief Executive Officer Steve Ledger, the company is pleased to have delivered this milestone ahead of schedule, reflecting efficient collaboration among investigators, clinical sites, and participating patients. Serina also acknowledged the contribution of study volunteers and clinical investigators, emphasizing that their participation is helping advance new treatment options for individuals living with advanced Parkinson’s disease. The company expects to provide another update after the Safety Monitoring Committee completes its review and confirms the appropriate next dosing strategy for the ongoing registrational study.
SER-252 Trial Designed to Evaluate Safety and Early Clinical Benefits
The ongoing SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b registrational trial evaluating the safety, tolerability, pharmacokinetics, and exploratory efficacy of subcutaneous SER-252 in adults with Parkinson’s disease experiencing motor fluctuations. The study includes a single-ascending-dose phase consisting of five cohorts of eight participants each (40 patients total) followed by a multiple-ascending-dose phase with up to three cohorts of sixteen participants each (48 patients total). In addition to measuring safety outcomes, investigators are assessing Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor scores and structured motor-state assessments to explore potential clinical improvements. Clinical sites are currently operating in the United States and Australia, with additional expansion planned in South Korea and Taiwan, supporting broader patient enrollment as the study progresses through subsequent dose-escalation stages.
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POZ Platform Supports Long-Acting Parkinson’s Therapy Development
SER-252, also known as POZ-apomorphine, has been developed using Serina Therapeutics’ proprietary POZ Platform™, a synthetic poly(2-oxazoline) polymer technology designed to improve drug delivery by providing greater control over drug loading and sustained release following subcutaneous injection. The investigational therapy aims to deliver continuous dopaminergic stimulation, an approach that has been associated with reducing levodopa-related motor complications and dyskinesia in Parkinson’s disease. Preclinical studies have also suggested the potential to maintain continuous therapeutic drug levels without the skin reactions commonly associated with conventional apomorphine therapies. Beyond SER-252, Serina believes its POZ Platform™ has broad applications across small molecules, RNA therapeutics, lipid nanoparticle formulations, and antibody-drug conjugates, enabling future licensing and partnership opportunities. With Cohort 1 enrollment and dosing successfully completed, the company is now focused on the upcoming safety review that will determine progression into the next phase of clinical development while continuing efforts to expand its investigational program internationally.
Source: Serina Therapeutics, press release
