Serina Therapeutics, Inc.(SER), a clinical-stage biotechnology company, announced that it has dosed the first patient in its Phase 1b registrational clinical trial evaluating SER-252 in patients with advanced Parkinson's disease.
SER-252(POZ-apomorphine) is Serina's lead investigational apomorphine therapy developed with POZ platform and designed to provide continuous dopaminergic stimulation (CDS) in Parkinson's disease. CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson's disease.
In January 2026, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SER-252.
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.
Serina has engaged in regulatory interactions with the FDA regarding the SER-252 program, including receipt of written FDA feedback supporting the proposed registrational clinical trial design under a 505(b)(2) NDA pathway.
With FDA alignment on their 505(b)(2) NDA pathway and recognition of Phase 1b trial as registrational, they are positioned to efficiently generate the clinical data necessary to bring SER-252 to market, said Steve Ledger, Chief Executive Officer of Serina.
In addition, Serina has partnered with Parkinson's Australia and Neuroscience Trials Australia to support patient identification and enrollment activities.
Also, Serina expects that the blinded safety and tolerability review by the Safety Monitoring Committee from Cohort 1 will allow advancement to Cohort 2 in the third quarter of 2026.
Serina estimates that over 10 million people in the world are currently living with Parkinson's disease.
Serina's POZ Platform has the potential to improve the integrated efficacy and safety profile of multiple modalities, including small molecules, RNA-based therapeutics, and antibody-drug conjugates (ADCs). POZ technology is based on a synthetic, water-soluble, low viscosity polymer called poly(2-oxazoline).
Serina's investigational pipeline includes:
-POZ-lipids, a non-immunogenic alternative to the PEG-lipids in the lipid nanoparticles.
-SER 214 for the treatment of early Parkinson's and Restless Leg Syndrome, which has completed phase 1a clinical trial.
-POZ-RNA technology in lipid nanoparticle-delivered ribonucleic acid vaccines for infectious diseases.
-SER-270(POZ_VMAT2i), a VMAT2 inhibitor-based long-acting injectable (LAI) in movement disorders, Tardive Dyskinesia & Huntington's Chorea. The Company expects to complete formulation optimisation and pre-IND activities in 2026.
For the third quarter ended on September 30, 2025, the firm reported moving to a net loss of $4.59 million, or $0.45 per share, from a net profit of $1.41 million, or $0.13 per share, in the year-ago period.
SER has traded between $1.53 and $7.92 in the last year. SER closed Tuesday's trade at $1.67, up 6.37%.
In the overnight market, SER is up 2.99% at $1.72.
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