Serina Therapeutics Advances POZ-VMAT2i into Development for Tardive Dyskinesia (TD)
Serina Therapeutics (NYSE:SER) announced the advancement of SER-270 (POZ-VMAT2i), a novel once-weekly injectable VMAT2 inhibitor for treating tardive dyskinesia (TD). The drug leverages Serina's proprietary POZ Platform™ technology to provide a long-acting alternative to daily oral medications.
The U.S. TD market, which exceeded $3.7 billion in sales in 2024, is projected to reach $5.4 billion by 2030. Currently, fewer than 30% of U.S. TD patients are diagnosed, with less than half receiving treatment. The company also plans to explore the drug's potential for treating chorea associated with Huntington's disease.
POZ-VMAT2i specifically targets underserved patients who struggle with daily medication adherence, institutionalized patients, and those with dysphagia, offering a potentially transformative solution in the VMAT2 inhibitor market.
Serina Therapeutics (NYSE:SER) ha annunciato il progresso di SER-270 (POZ-VMAT2i), un nuovo inibitore VMAT2 iniettabile una volta alla settimana per il trattamento della discinesia tardiva (TD). Il farmaco sfrutta la tecnologia proprietaria POZ Platform™ di Serina per offrire un'alternativa a lunga durata d'azione ai farmaci orali assunti quotidianamente.
Il mercato statunitense della TD, che ha superato 3,7 miliardi di dollari di vendite nel 2024, è previsto raggiungere 5,4 miliardi di dollari entro il 2030. Attualmente, meno del 30% dei pazienti con TD negli Stati Uniti viene diagnosticato e meno della metà riceve un trattamento. L'azienda intende inoltre esplorare il potenziale del farmaco per il trattamento della corea associata alla malattia di Huntington.
POZ-VMAT2i si rivolge in modo specifico ai pazienti meno assistiti, come quelli che hanno difficoltà ad assumere farmaci quotidianamente, i pazienti istituzionalizzati e chi soffre di disfagia, offrendo una soluzione potenzialmente rivoluzionaria nel mercato degli inibitori VMAT2.
Serina Therapeutics (NYSE:SER) anunció el avance de SER-270 (POZ-VMAT2i), un nuevo inhibidor de VMAT2 inyectable una vez a la semana para el tratamiento de la discinesia tardía (TD). El medicamento utiliza la tecnología patentada POZ Platform™ de Serina para ofrecer una alternativa de acción prolongada a los medicamentos orales diarios.
El mercado estadounidense de TD, que superó los 3.7 mil millones de dólares en ventas en 2024, se proyecta que alcance los 5.4 mil millones para 2030. Actualmente, menos del 30% de los pacientes con TD en EE.UU. son diagnosticados y menos de la mitad recibe tratamiento. La compañía también planea explorar el potencial del medicamento para tratar la corea asociada con la enfermedad de Huntington.
POZ-VMAT2i está dirigido específicamente a pacientes desatendidos que tienen dificultades para cumplir con la medicación diaria, pacientes institucionalizados y aquellos con disfagia, ofreciendo una solución potencialmente transformadora en el mercado de inhibidores VMAT2.
Serina Therapeutics (NYSE:SER)는 지연성 운동장애(TD) 치료를 위한 새로운 주 1회 주사형 VMAT2 억제제인 SER-270 (POZ-VMAT2i)의 개발 진전을 발표했습니다. 이 약물은 Serina의 독자적인 POZ Platform™ 기술을 활용하여 매일 복용하는 경구 약물에 대한 장기 지속형 대안을 제공합니다.
미국의 TD 시장은 2024년에 37억 달러 이상의 매출을 기록했으며, 2030년까지 54억 달러에 이를 것으로 예상됩니다. 현재 미국 내 TD 환자의 30% 미만만 진단받고 있으며, 그중 절반도 치료를 받고 있지 않습니다. 회사는 또한 헌팅턴병과 관련된 무도병 치료 가능성도 탐색할 계획입니다.
POZ-VMAT2i는 매일 약 복용이 어려운 환자, 시설에 입원한 환자, 연하곤란이 있는 환자 등 돌봄이 부족한 환자들을 대상으로 하며, VMAT2 억제제 시장에서 잠재적으로 혁신적인 해결책을 제시합니다.
Serina Therapeutics (NYSE:SER) a annoncé l’avancement de SER-270 (POZ-VMAT2i), un nouvel inhibiteur VMAT2 injectable une fois par semaine pour le traitement de la dyskinésie tardive (TD). Ce médicament exploite la technologie propriétaire POZ Platform™ de Serina pour offrir une alternative à longue durée d’action aux médicaments oraux pris quotidiennement.
Le marché américain de la TD, qui a dépassé 3,7 milliards de dollars de ventes en 2024, devrait atteindre 5,4 milliards de dollars d’ici 2030. Actuellement, moins de 30 % des patients américains atteints de TD sont diagnostiqués, et moins de la moitié reçoivent un traitement. L’entreprise prévoit également d’explorer le potentiel du médicament pour traiter la chorée associée à la maladie de Huntington.
Le POZ-VMAT2i cible spécifiquement les patients insuffisamment pris en charge, notamment ceux ayant des difficultés à suivre un traitement quotidien, les patients institutionnalisés et ceux souffrant de dysphagie, offrant une solution potentiellement révolutionnaire sur le marché des inhibiteurs VMAT2.
Serina Therapeutics (NYSE:SER) gab den Fortschritt von SER-270 (POZ-VMAT2i) bekannt, einem neuartigen, einmal wöchentlich injizierbaren VMAT2-Inhibitor zur Behandlung der tardiven Dyskinesie (TD). Das Medikament nutzt Serinas proprietäre POZ Platform™-Technologie, um eine langwirksame Alternative zu täglich eingenommenen oralen Medikamenten zu bieten.
Der US-amerikanische TD-Markt, der im Jahr 2024 einen Umsatz von über 3,7 Milliarden US-Dollar erzielte, wird voraussichtlich bis 2030 5,4 Milliarden US-Dollar erreichen. Derzeit werden weniger als 30 % der TD-Patienten in den USA diagnostiziert, und weniger als die Hälfte erhält eine Behandlung. Das Unternehmen plant außerdem, das Potenzial des Medikaments zur Behandlung der mit der Huntington-Krankheit verbundenen Chorea zu untersuchen.
POZ-VMAT2i richtet sich speziell an unterversorgte Patienten, die Schwierigkeiten haben, täglich Medikamente einzunehmen, an institutionalisierte Patienten und an solche mit Dysphagie, und bietet eine potenziell bahnbrechende Lösung im Markt für VMAT2-Inhibitoren.
- Addresses large market opportunity with TD market projected to reach $5.4 billion by 2030
- Once-weekly administration provides competitive advantage over existing daily oral medications
- Targets underserved patient populations including non-compliant and institutionalized patients
- Potential expansion into Huntington's disease chorea market
- Early-stage development with no efficacy data presented
- Entering competitive market with established oral VMAT2 inhibitors
- Low TD diagnosis rate (under 30%) may impact market penetration
Insights
Serina's weekly injectable VMAT2 inhibitor targets significant adherence challenges in tardive dyskinesia, addressing a $3.7B market with substantial growth potential.
Serina Therapeutics is advancing SER-270 (POZ-VMAT2i), a novel approach to treating tardive dyskinesia that transforms conventional oral VMAT2 inhibitors into a once-weekly subcutaneous injection. This development addresses three critical challenges in the current treatment landscape: medication adherence, institutional access barriers, and dysphagia complications.
The clinical significance cannot be overstated. Current oral VMAT2 inhibitors, while effective, face substantial real-world limitations in a population already struggling with complex medication regimens. Many TD patients have underlying psychiatric conditions requiring antipsychotic medications - the very drugs causing their movement disorder. This creates a challenging medication burden that often leads to poor adherence.
What makes this development particularly compelling is the market opportunity. With $3.7 billion in U.S. sales for TD treatments in 2024 and projections reaching $5.4 billion by 2030, there's significant commercial potential. Yet, the current treatment penetration remains remarkably low - fewer than 30% of TD patients are diagnosed, and less than half of those receive pharmacologic treatment.
The therapeutic expansion into Huntington's chorea represents another strategic advantage. Huntington's patients frequently experience dysphagia, making oral medications particularly challenging. A once-weekly injectable could significantly improve quality of life while reducing caregiver burden in this population.
This approach mirrors successful paradigm shifts we've seen in psychiatry, where long-acting injectable antipsychotics dramatically improved outcomes for non-adherent patients. POZ-VMAT2i could represent a similar breakthrough for movement disorders, potentially expanding the treatable population substantially beyond current reach.
- Novel once-weekly injectable VMAT2 inhibitor targets underserved patients with serious adherence and access challenges –
- Potential expansion into Huntington’s chorea – an underserved indication with high need for long-acting VMAT2 therapy -
HUNTSVILLE, AL, July 29, 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 the advancement of its novel product candidate, SER-270, a proprietary POZ-conjugated vesicular monoamine transporter 2 (VMAT2) inhibitor in development for the treatment of tardive dyskinesia (TD).
SER-270, also referred to as POZ-VMAT2i, leverages Serina’s proprietary POZ polymer technology to enable long-acting, once weekly subcutaneous administration, offering a potentially transformative alternative to existing oral VMAT2 inhibitors. The candidate is designed to meet the needs of underserved TD patients who struggle with daily medication adherence, including those already managed with long-acting injectable (LAI) antipsychotics.
Addressing Significant Unmet Needs in TD: A Large and Under-Treated Market
TD is a disabling and often stigmatizing movement disorder caused by long-term exposure to antipsychotic medications. It predominantly affects those with chronic psychiatric conditions such as schizophrenia and bipolar disorder who may have difficulty adhering to complex daily medication regimens. While oral VMAT2 inhibitors are the only approved class for TD, uptake remains modest due to underdiagnosis, low disease awareness among clinicians, and the challenges of ensuring daily medication adherence in complex, high-risk populations. It is estimated that fewer than
POZ-VMAT2i is uniquely positioned to address these barriers by offering:
- Once-weekly, long-acting injectable administration, critical for patients non-compliant with daily oral medications, including those currently managed with long-acting injectable (LAI) antipsychotics.
- Improved access for institutionalized patients, where daily oral therapy poses logistical challenges for nursing and care staff.
- A non-oral solution for patients with dysphagia (chewing/swallowing difficulties), a common complication among elderly and neurologically impaired individuals.
Expanding into Huntington’s Disease Chorea: A High Need Secondary Indication
Serina also plans to explore development of POZ-VMAT2i for chorea associated with Huntington’s disease, a neurodegenerative disorder marked by progressive movement impairment and often, serious swallowing difficulties. A weekly injectable therapy may offer meaningful advantages over current oral options for this population and their caregivers.
“POZ-VMAT2i embodies Serina’s commitment to solving real-world challenges for patients and caregivers who are often left behind by traditional therapies,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “By targeting non-compliant, institutionalized, and dysphagic patients with a transformative once-weekly injectable, we believe we can meaningfully expand access to proven VMAT2 inhibitor therapy and improve patient lives.”
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://serinatherapeutics.com.
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
sriley@serinatherapeutics.com
(256) 327-9630
FAQ
What is Serina Therapeutics' new drug SER-270 (POZ-VMAT2i) designed to treat?
How big is the tardive dyskinesia market that Serina Therapeutics (SER) is targeting?
What advantages does Serina's POZ-VMAT2i offer over existing TD treatments?
What additional indication is Serina Therapeutics exploring for POZ-VMAT2i?
What percentage of TD patients currently receive treatment?
