Serina Completes Sentinel Dosing in Cohort 1 of Phase Ib Trial for Parkinson’s

Serina Therapeutics has completed sentinel dosing in Cohort 1 of its Phase Ib registrational trial of SER-252 in adults with advanced Parkinson’s disease. The independent safety monitoring committee reviewed initial safety and tolerability data from the first 72 hours and recommended continuation, allowing dosing of additional participants in the cohort. The company previously announced first patient enrollment on February 19 and dosing on February 24.

The placebo-controlled, double-blind study is being conducted at sites in Australia and the United States, with plans to expand into South Korea and Taiwan in later stages. Serina expects to complete enrollment and dosing in Cohort 1 ahead of the previously guided end of the third quarter of 2026, subject to continued successful execution.

The SER-252-1b study includes both single-ascending-dose and multiple-ascending-dose components. Up to five cohorts of eight participants each will receive a single dose, and up to three cohorts of 16 participants will be enrolled for multiple dosing. The trial’s primary objectives are safety, tolerability, and pharmacokinetics, while exploratory measures include MDS-UPDRS motor scores and motor-state assessments.

Serina has received alignment from the U.S. Food and Drug Administration on a 505(b)(2) New Drug Application pathway and the designation of this Phase 1b study as registrational. Blinded review of Cohort 1 data by the Safety Monitoring Committee, along with advancement to Cohort 2, is anticipated in the third quarter of 2026.

SER-252 is an investigational apomorphine therapy developed using Serina’s POZ Platform, a poly(2-oxazoline) polymer technology designed to enable controlled drug loading and sustained release. The therapy is intended to provide continuous dopaminergic stimulation to reduce levodopa-related motor complications in Parkinson’s disease and is administered via convenient subcutaneous injection, potentially avoiding the burden of infusion-based approaches. The CEO noted that the sentinel dosing completion represents an early operational milestone and that the company remains focused on advancing SER-252 in a disciplined, data-driven manner.

In recent regulatory filings, Serina disclosed an NYSE equity deficiency and a $20 million convertible note financing arrangement to fund operations.