Breakthrough Clinical Results
Serina Therapeutics announced the advancement of SER-270 (POZ-VMAT2i), a novel, once-weekly injectable VMAT2 inhibitor, for treating tardive dyskinesia (TD). This long-acting formulation addresses challenges with daily oral medication adherence common in TD patients, including those on long-acting injectable antipsychotics. POZ-VMAT2i offers improved access for institutionalized patients and those with dysphagia. Serina also plans to explore its use in Huntington's disease chorea. The company highlights the significant unmet needs in the TD market, with low diagnosis and treatment rates despite a large market size projected to grow to $5.4 billion by 2030.
Key Highlights
- Advancement of SER-270 (POZ-VMAT2i), a once-weekly injectable VMAT2 inhibitor for tardive dyskinesia (TD)
- Addresses adherence challenges in TD patients, including those on LAI antipsychotics
- Improved access for institutionalized patients and those with dysphagia
- Potential expansion into Huntington's disease chorea
Incidence and Prevalence
Global Epidemiology of Tardive Dyskinesia
Prevalence Rates
The most recent data from 2012 indicates that tardive dyskinesia remains a major concern in psychiatry with an average prevalence of 15%-20% across various populations. Epidemiologic data suggest that the prevalence of the disorder has increased over the past two decades.
A 1992 meta-analysis of 76 studies examining 39,187 patients found an overall prevalence of 24.2%. This analysis revealed that prevalence was significantly higher in women (26.6%) than in men (21.6%), though this gender difference appeared to narrow in more recent studies at that time.
Regional variations are notable. A 1992 study in Chinese psychiatric patients in Hong Kong found prevalence rates of 9.3% for tardive dyskinesia, which were much lower than those found in Western studies, suggesting a possible ethnic difference. Similarly, a 2003 study at Mathari Hospital in Kenya found a prevalence rate of 11.9% among psychiatric in-patients, which was noted to be lower than Western rates but similar to Asian studies.
An international survey of chronic schizophrenia (1987) found abnormal movements present in 28% of 739 patients, with a prevalence rate of 13.6% using the more stringent Research Criteria for Tardive Dyskinesia. A 1978 study in a state-wide mental hospital system found 26% of patients had definite signs of tardive dyskinesia, about 12% had moderately severe dyskinesia, and 40% exhibited at least some minimal symptoms.
Incidence Rates
The incidence of tardive dyskinesia in a young adult population (mean age 27) is 14% after 4 years of cumulative neuroleptic exposure. A 1997 longitudinal prospective study reported the cumulative incidence of severe tardive dyskinesia was 2.5% after one year, 12.1% after two years, and 22.9% after three years in middle-aged and elderly neuropsychiatric patients.
Risk Factors
Age remains the single most important risk factor for the development of tardive dyskinesia. TD prevalence appears to reach its peak in the 50-70-year-old age group in men and continues to rise after age 70 in women. Women tend to have more severe TD than men, and spontaneous dyskinesia is also more common in women.
Other risk factors include higher daily doses of neuroleptics, greater cumulative amounts of prescribed neuroleptic, and greater severity of worsening negative symptoms. Patients on multiple neuroleptic drugs had higher prevalence of moderately severe dyskinesia.
A 2008 meta-analysis of genetic studies suggests multiple genetic influences on tardive dyskinesia, indicative of pharmacogenetic interactions.
Cultural differences have been observed with Asian patients having lower prevalence of TD than North American, European, and African patients, suggesting possible racial differences in the aetiology of TD.
Economic Burden
Economic Burden of Treating Tardive Dyskinesia in USA and Europe
United States Economic Impact
According to 2022 research, psychiatric inpatients with tardive dyskinesia (TD) face significantly higher healthcare costs compared to those without TD. These patients experience extended hospitalization by an average of 6.36 days and incur $20,415 higher costs per hospitalization.
TD patients demonstrate about six-fold higher odds of severe morbidity and require higher acute inpatient care, substantially contributing to the overall economic burden. The economic impact is further compounded by higher likelihood for cardio-metabolic comorbidities including obesity (OR 1.61), hypertension (OR 1.78), and diabetes (OR 1.54).
Demographic disparities exist in TD prevalence, with African Americans showing two-fold higher odds of TD, potentially indicating uneven distribution of economic burden across population groups. Patients with schizophrenia and bipolar disorder (depressive) demonstrate four-fold higher odds of TD, suggesting these specific patient populations may face greater economic challenges related to TD management.
European Economic Impact
In Europe, a 2001 French study estimated the total annual medical cost of dyskinesias between 588 and 812 million francs. This research demonstrated a positive gradient of medical cost with level of dyskinesia severity, confirming that costs increase proportionally with condition severity.
The presence of dyskinesias significantly impacted treatment costs and medical visits, with mean monthly costs for patients with dyskinesias being more than three times higher than those without (FF 3,733 versus FF 1,109, p=0.0005). Additionally, more severe dyskinesia status correlates with greater need for caregivers, further increasing the economic burden.
Transfusion Dependence Comparison
While not specific to TD, related research on transfusion dependence provides context for understanding chronic condition economic impacts. A 2018 study of myelodysplastic syndromes (MDS) patients found that transfusion-dependent patients incurred a mean total cost of $17,815/patient-month, which was 53% higher for those requiring more frequent transfusions.
Patients who achieved transfusion independence had mean total costs of $7,874/patient-month, demonstrating significant cost savings when dependency is reduced. A 2021 systematic literature review confirmed lower healthcare resource utilization for transfusion-independent patients compared to transfusion-dependent patients.
These findings collectively highlight the substantial economic burden associated with tardive dyskinesia in both US and European healthcare systems, with costs driven by extended hospitalizations, increased comorbidities, and greater care needs as severity increases.
SER-270 (POZ-VMAT2i) Clinical Trials Beyond Tardive Dyskinesia
Based on the available information, there is insufficient data regarding SER-270 (POZ-VMAT2i) clinical trials for indications other than Tardive dyskinesia. The context does not provide specific information about:
- Clinical trials of SER-270 for other indications
- Intervention models used in such trials
- Dosing regimens specific to SER-270
- Comparative data between SER-270 and other VMAT2 inhibitors
While the context mentions that some VMAT2 inhibitors have been studied for conditions like Tourette syndrome and non dopa-responsive dystonia, these references appear to be about the broader class of VMAT2 inhibitors rather than specifically about SER-270.
Without additional information about SER-270's specific clinical development program, a comprehensive answer about its trials for other indications cannot be provided at this time.