Serina Therapeutics Announces Completion of Sentinel Dosing in Cohort 1 of Phase 1b Registrational Trial of SER-252 for Advanced Parkinson’s Disease
- Data Safety Monitoring Committee completed initial review of sentinel dosing observations and recommended continued dosing in Cohort 1 -
- Dosing of additional patients in Cohort 1 is underway at sites in the US and Australia -
- Company is on track to complete Cohort 1 enrollment and dosing ahead of previously disclosed guidance of the end of the third quarter of 2026 –
HUNTSVILLE, Ala., July 09, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced the completion of sentinel dosing in Cohort 1 of its ongoing Phase 1b registrational clinical trial evaluating SER-252 in patients with advanced Parkinson’s disease.
Following review of initial 72-hour safety and tolerability observations from the sentinel dosing group, the study’s independent Safety Monitoring Committee recommended that dosing continue in the remainder of Cohort 1. Additional patient dosing in Cohort 1 is now underway across sites in the United States and Australia.
“Completion of sentinel dosing represents an important early operational milestone in the Phase 1b registrational study of SER-252,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “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.”
Serina previously guided that completion of enrollment and dosing in Cohort 1 was expected by the end of the third quarter of 2026. Based on current site activity and patient screening and dosing, the Company now expects to complete enrollment and dosing of Cohort 1 ahead of that timeline, subject to continued trial execution.
The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b registrational trial with single-ascending-dose and multiple-ascending-dose components in adults with Parkinson’s disease and motor fluctuations. The study is designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation is overseen by a Safety Monitoring Committee, and the study is being conducted across sites in Australia and the United States, with plans to bring on sites in South Korea and Taiwan as the study advances through subsequent cohorts.
SER-252 Registrational Study Design Overview
The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson’s disease and motor fluctuations. The registrational study is designed to evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation will be overseen by an independent Safety Monitoring Committee, and the study is being conducted across sites in the United States, Australia with plans to South Korea and Taiwan.
About the POZ Platform™
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 therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.
Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.
About SER-252 (POZ-apomorphine)
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.
About Serina Therapeutics
Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform™ provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.
For more information, please visit https://serinatx.com.
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These statements are based on management’s current expectations, plans, beliefs, or forecasts for the future, and are subject to uncertainty and changes in circumstances. The facts and assumptions underlying these statements may change, and undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made. Any statements that are not historical fact (including, but not limited to statements that contain words such as “may,” “will,” “believes,” “plans,” “intends,” “anticipates,” "targeting," “expects,” or “estimates”) should be considered to be forward-looking statement, including statements about the potential of Serina’s POZ polymer technology, Serina’s estimates regarding future revenue, expenses, capital requirements and need for additional financing, and Serina’s planned clinical programs, including planned clinical trials. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory holds, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; Serina’s ability to continue as a going concern; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the company’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and, except as required by law, Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630
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