Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway
Serina Therapeutics (NYSE American: SER) received positive FDA feedback supporting the advancement of SER-252, their POZ-enabled apomorphine treatment for advanced Parkinson's disease, through a 505(b)(2) NDA pathway. The company plans to initiate a registrational clinical study program with a comprehensive development strategy.
Key upcoming milestones include U.S. IND submission in Q4 2025, patient dosing in Australia in Q4 2025, and U.S. enrollment beginning in Q1 2026. The registrational study, SER-252-1b, is designed as a randomized, double-blind, placebo-controlled Phase 1b trial, evaluating safety, tolerability, and pharmacokinetics in Parkinson's disease patients with motor fluctuations.
Serina Therapeutics (NYSE American: SER) ha ricevuto riscontri positivi dalla FDA a sostegno dell'avanzamento di SER-252, il loro trattamento con apomorfina abilitato da POZ per il morbo di Parkinson avanzato, tramite il percorso NDA 505(b)(2). La società prevede di avviare un programma clinico registrativo con una strategia di sviluppo completa.
I principali traguardi imminenti includono la presentazione dell'IND negli USA nel 4° trimestre 2025, la somministrazione ai pazienti in Australia nel 4° trimestre 2025 e l'inizio delle arruolamenti negli USA nel 1° trimestre 2026. Lo studio registrativo, SER-252-1b, è progettato come uno studio randomizzato, in doppio cieco, controllato con placebo di Fase 1b, volto a valutare la sicurezza, la tollerabilità e la farmacocinetica in pazienti con morbo di Parkinson e fluttuazioni motorie.
Serina Therapeutics (NYSE American: SER) recibió comentarios positivos de la FDA que respaldan el avance de SER-252, su tratamiento con apomorfina habilitado por POZ para la enfermedad avanzada de Parkinson, a través de la vía NDA 505(b)(2). La compañía planea iniciar un programa clínico registracional con una estrategia de desarrollo integral.
Los hitos próximos clave incluyen la presentación del IND en EE. UU. en el 4T 2025, la dosificación de pacientes en Australia en el 4T 2025 y el inicio del reclutamiento en EE. UU. en el 1T 2026. El estudio registracional, SER-252-1b, está diseñado como un ensayo aleatorizado, doble ciego y controlado con placebo de Fase 1b, que evaluará la seguridad, tolerabilidad y farmacocinética en pacientes con enfermedad de Parkinson y fluctuaciones motoras.
Serina Therapeutics (NYSE American: SER)� 진행� 파킨슨병 치료� 위한 POZ 기반 아포모르핀 제제 SER-252� 추진� FDA로부� 긍정적인 피드백을 받아 505(b)(2) NDA 경로� 통해 진행� � 있게 되었습니�. 회사� 포괄적인 개발 전략� 갖춘 등록 임상 시험 프로그램� 시작� 계획입니�.
주요 예정 마일스톤으로� 미국 IND 제출: 2025� 4분기, 호주에서� 환자 투약: 2025� 4분기, � 미국 등록 시작: 2026� 1분기가 포함됩니�. 등록 시험 SER-252-1b� 무작위배�, 이중맹검, 위약대조의 1b상으� 설계되어 파킨슨병� 운동 변동을 가� 환자에서 안전�, 내약� � 약동학을 평가합니�.
Serina Therapeutics (NYSE American: SER) a reçu un retour positif de la FDA soutenant l'avancement de SER-252, leur traitement à base d'apomorphine équipé de POZ pour la maladie de Parkinson avancée, via la voie NDA 505(b)(2). La société prévoit de lancer un programme d'études cliniques d'enregistrement avec une stratégie de développement globale.
Les jalons clés à venir incluent la dépôt de l'IND aux États-Unis au T4 2025, le traitement des patients en Australie au T4 2025 et le début des recrutements aux États-Unis au T1 2026. L'étude d'enregistrement, SER-252-1b, est conçue comme un essai randomisé, en double aveugle, contrôlé par placebo de phase 1b, visant à évaluer la sécurité, la tolérabilité et la pharmacocinétique chez des patients atteints de la maladie de Parkinson avec fluctuations motrices.
Serina Therapeutics (NYSE American: SER) erhielt positive Rückmeldung von der FDA, die die Weiterentwicklung von SER-252, ihrer POZ-ermöglichten Apomorphin-Behandlung für fortgeschrittenes Parkinson, über den 505(b)(2) NDA-Weg unterstützt. Das Unternehmen plant den Start eines registrierenden klinischen Studienprogramms mit einer umfassenden Entwicklungsstrategie.
Wichtige bevorstehende Meilensteine sind die US-IND-Einreichung im 4. Quartal 2025, die Dosierung von Patienten in Australien im 4. Quartal 2025 und der Beginn der US-Einschreibung im 1. Quartal 2026. Die registrierende Studie SER-252-1b ist als randomisierte, doppelblinde, placebokontrollierte Phase-1b-Studie konzipiert, die Sicherheit, Verträglichkeit und Pharmakokinetik bei Parkinsonpatienten mit motorischen Schwankungen bewertet.
- None.
- Multiple clinical trial phases still required before potential approval
- Complex study design with multiple cohorts may extend development timeline
Insights
FDA feedback supports Serina's 505(b)(2) pathway for Parkinson's drug SER-252, significantly de-risking regulatory strategy while maintaining long development timeline.
The FDA's written feedback supporting Serina Therapeutics' registrational trial design for SER-252 represents a significant regulatory milestone. The 505(b)(2) NDA pathway approval is particularly valuable as it allows Serina to leverage existing data on apomorphine while incorporating their proprietary POZ Platform� technology. This approach can substantially reduce development costs and timeline risks compared to traditional development pathways.
The regulatory strategy includes a pharmacokinetic bridging component to an approved apomorphine product, which is precisely the type of approach the FDA looks for in 505(b)(2) applications. What's notably advantageous is that the FDA has indicated Serina's initial study—a Phase 1b trial—may be designed as a component of the registrational program, subject to standard requirements.
The planned trial (SER-252-1b) follows a rigorous design: randomized, double-blind, and placebo-controlled with both single-ascending-dose (n=40) and multiple-ascending-dose (n=48) components. The inclusion of exploratory efficacy measures such as MDS-UPDRS motor scores alongside pharmacokinetic data reflects a comprehensive evaluation approach.
While this news provides regulatory clarity, investors should note the extended timeline�IND filing in Q4 2025 and U.S. enrollment in Q1 2026. The FDA's supportive feedback on the 505(b)(2) strategy also establishes a potential precedent for Serina's broader pipeline, as explicitly noted by management. This regulatory validation may accelerate future programs utilizing the same platform technology.
-U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026
- Patient dosing expected to begin in Australia in Q4 2025
HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina�) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform� drug optimization technology, today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA’s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson’s under the 505(b)(2) NDA pathway.
“People living with advanced Parkinson’s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function,� said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “Based on the FDA’s written feedback, we plan to advance SER-252 on a registration-directed 505(b)(2) NDA regulatory pathway. Our development plan is designed to be rigorous and capital efficient. We aim to streamline a potential NDA while generating the clinical and pharmacologic evidence to support regulatory review and improve patients� lives.�
In its discussions with the FDA, Serina outlined a program designed to leverage prior knowledge of apomorphine utilizing the company’s POZ-enabled profile. Serina plans to include a pharmacokinetic (PK) bridging component to an approved apomorphine product, consistent with a 505(b)(2) NDA strategy. The FDA’s feedback indicates that Serina’s initial study may be designed and conducted as a component of a registrational trial program, subject to standard clinical and nonclinical requirements and finalization of documentation at the time of IND submission.
“Beyond SER-252, we are advancing a pipeline of POZ-enabled small molecules that may follow similar 505(b)(2) NDA pathways where appropriate,� said Mr. Ledger. “The FDA’s feedback provides early proof-of-principle for our platform, confirming that we can effectively align with the agency's expectations for the 505(b)(2) NDA regulatory pathway. Each program will follow its own science and require FDA dialogue, but our goal remains to unlock new possibilities in treatment and deliver better options to patients as quickly as possible.�
Upcoming Regulatory and Clinical Milestones
Serina plans to submit the U.S. IND application in Q4 2025 incorporating the FDA’s recommendations. In parallel, the company expects to begin dosing patients in Australia in Q4 2025 as part of the global registrational program, with data from these patients expected to contribute to the overall data package for regulatory review and potential approval. Following U.S. IND clearance, Serina anticipates initiation of enrollment in the U.S. in Q1 2026.
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 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 a Safety Review Committee and the study will be conducted across sites in the U.S. and Australia.
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) via a single or twice-weekly subcutaneous injection. CDS has been shown to reduce the severity of motor fluctuations (which includes levodopa-induced dyskinesia) and enable greater daily on time, with reduced off time, in advanced Parkinson’s patients. SER-252 leverages strategic partner Enable Injections� enFuse� wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection.
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 severe skin reactions, side effects due to peak-trough variations in drug levels and a short half-life. Serina believes that by using POZ technology, drugs with a narrow therapeutic index 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.
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 .
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws. 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. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 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 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; 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 Serina’s Annual Report on Form 10-K, and Serina’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 Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. The information contained in this release is as of the date hereof, and 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
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