In Lundbeck we recently initiated a global clinical study, 20058N (Talisman), in Multiple System Atrophy (MSA) at multiple research centers in China and Europe. The results from the study will support MSA drug development, including helping to identify the target population for clinical trials and evaluate treatment effects more consistently, all for the benefit of the patients we are here for.
The Talisman study is an observational, retro-prospective, international, multicenter cohort study, which will explore disease progression (China and EU) and related biomarkers (EU) in a cohort of relatively early stage MSA patients. The Talisman study will help to better understand the epidemiology of the early stages of the disease over a longer period, compared to previous studies.
In China, the study will also confirm the psychometric properties of the Chinese version of the Unified MSA Rating Scale (UMSARS), which may enable China to participate in future global MSA studies on the same timelines as other countries.
The Unified MSA Rating Scale (UMSARS) was developed to provide a surrogate measure of disease progression, and is considered the global standard for the clinical evaluation of MSA. By using the same scale, Lundbeck will be able to harvest data in a more consistent way, thus enabling more robust, global clinical trials in the future.
In China, MSA has been included in the first batch of rare disease catalogue, but there is a lack of epidemiological data of MSA. The Talisman study will help to better understand the epidemiology of the disease across the participating sites.
The learnings from the Talisman study will support MSA drug development, including helping to identify the target population for clinical trials, and evaluate treatment effects more consistently.
MSA is a rare, sporadic, rapidly progressing neurodegenerative disease with a prevalence estimate ranging from 2 to 5 per 100,000 in the US and EU. The current diagnostic criteria divide MSA into two subtypes; MSA with predominant extrapyramidal parkinsonism symptoms (MSA-P) and MSA where cerebellar ataxia symptoms predominate (MSA-C), with approximately 70% being MSA-P.
Most MSA patients are diagnosed between 50 to 60 years of age, and the mean survival time is 6 to 10 years from symptom onset. As MSA is difficult to diagnose, some patients have had a long journey towards diagnosis.
At present, the Talisman study has been successfully initiated in China, where the First Patient First Visit was achieved June 25th, 2022. The study is expected to start in the EU October 2022.