Serina Therapeutics Enrolls First Patient in Phase 1b Trial of SER-252 for Parkinson's Disease

Serina Therapeutics has enrolled the first patient in its Phase 1b registrational trial evaluating SER-252 in patients with advanced Parkinson's disease. The study is being conducted in Australia, and the company remains on track to initiate dosing during the first quarter of 2026, consistent with previously disclosed guidance.

The Phase 1b registrational study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SER-252 in patients with advanced Parkinson's disease whose symptoms are inadequately controlled by current standard-of-care therapies.

The company has established relationships with Parkinson's Australia and Neuroscience Trials Australia to support patient identification and enrollment activities. The company plans to provide further updates on the trial as patient enrollment progresses.

The Chief Executive Officer stated that the team has built a strong operational presence in Australia, working closely with leading Parkinson's disease specialists and patient advocacy organizations to support efficient enrollment. With FDA alignment on the registrational development strategy under a 505(b)(2) NDA pathway, the company is focused on executing this trial and generating meaningful clinical data for patients with advanced Parkinson's disease who face significant unmet medical needs.

SER-252 is an investigational apomorphine therapy developed with Serina's POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson's disease. Preclinical studies support the potential of SER-252 to provide CDS without skin reactions.

Serina's proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina's POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The company believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.

The company is also exploring broader applications of its POZ platform, including out-licensing agreements such as its non-exclusive license with Pfizer for lipid nanoparticle drug delivery formulations. Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.