Serina Therapeutics has announced the advancement of SER-270, a proprietary POZ-conjugated vesicular monoamine transporter 2 (VMAT2) inhibitor, into development for tardive dyskinesia (TD). The novel drug candidate, also referred to as POZ-VMAT2i, leverages the company's proprietary POZ polymer technology to enable once-weekly subcutaneous administration, positioning it as a potentially transformative alternative to existing oral VMAT2 inhibitors.
Addressing Critical Treatment Gaps in Tardive Dyskinesia
TD represents a disabling and often stigmatizing movement disorder caused by long-term exposure to antipsychotic medications. The condition predominantly affects individuals with chronic psychiatric conditions such as schizophrenia and bipolar disorder, populations that may struggle with adherence to complex daily medication regimens.
Despite oral VMAT2 inhibitors being the only approved therapeutic class for TD, treatment uptake remains modest due to multiple barriers. According to the company, fewer than 30% of U.S. TD patients receive a diagnosis, and less than half of those diagnosed receive pharmacologic treatment. These challenges stem from underdiagnosis, limited disease awareness among clinicians, and difficulties ensuring daily medication adherence in complex, high-risk patient populations.
The U.S. TD market exceeded $3.7 billion in sales in 2024, driven by increased recognition and broader reimbursement coverage. Market analysts project growth to $5.4 billion by 2030, highlighting significant opportunities for differentiated therapies that address adherence, access, and administration barriers.
Novel Delivery System Targets Underserved Populations
POZ-VMAT2i is designed to address specific treatment barriers through its unique delivery profile. The once-weekly, long-acting injectable formulation targets patients who are non-compliant with daily oral medications, including those currently managed with long-acting injectable antipsychotics.
The therapy also aims to improve access for institutionalized patients, where daily oral therapy creates logistical challenges for nursing and care staff. Additionally, the non-oral formulation provides a solution for patients with dysphagia, a common complication among elderly and neurologically impaired individuals who experience chewing and swallowing difficulties.
Expansion into Huntington's Disease
Serina plans to explore development of POZ-VMAT2i for chorea associated with Huntington's disease, a neurodegenerative disorder characterized by progressive movement impairment and often serious swallowing difficulties. The weekly injectable therapy may offer meaningful advantages over current oral options for this patient 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."
Company Platform Technology
Serina Therapeutics is a clinical-stage biotechnology company developing drug product candidates for neurological diseases and other indications. The company's POZ Platform technology aims to improve the integrated efficacy and safety profile of multiple therapeutic modalities, including small molecules, RNA-based therapeutics, and antibody-based drug conjugates. The company is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.
