Periodic Reporting for period 1 - Biomarkers for PD (Validation of diagnostic and prognostic biomarkers for Parkinson disease)
Berichtszeitraum: 2015-09-01 bis 2016-02-29
Parkinson’s disease is one of the most prevalent neurodegenerative disorders and a disease with a significant unmet medical need. World-wide, more than 4.6 million individuals over the age of 50 suffer from Parkinson’s disease and it is estimated that the number will more than double by 2030. Today, there are no reliable biochemical biomarkers for Parkinson’s disease and the disease is often difficult to diagnose. The differential diagnosis of Parkinson’s disease is based on clinical features and the golden standard still remains neuropathological confirmation. Misclassification, especially in early Parkinson’s disease, occurs frequently. High sensitivity and specificity can only be obtained at specialized centers, and after several years of follow-up. To be able to modify or halt the disease progression it is beneficial to initiate a disease modifying treatment at an earlier stage than what is possible today. The clinical validation of a sensitive and specific biomarker that also could mirror the treatment effect would make an enormous advantage and need to be developed in parallel with the development of new disease modifying therapeutics.
In this project we have:
• Acquired Human CSF from patients with Parkinson’s disease and healthy controls
• Conducted Biochemical biomarker assay development for Parkinson’s disease
• Conducted a pilot study on clinical cohorts including patients with Parkinson’s disease and healthy controls
• Evaluated the business opportunities and further development path for Parkinson’s disease biomarkers
In this project we have:
• Acquired Human CSF from patients with Parkinson’s disease and healthy controls
• Conducted Biochemical biomarker assay development for Parkinson’s disease
• Conducted a pilot study on clinical cohorts including patients with Parkinson’s disease and healthy controls
• Evaluated the business opportunities and further development path for Parkinson’s disease biomarkers
We have successfully established a sensitive and specific biochemical biomarker assay for cerebrospinal fluid analyses and measurements of soluble oligomer/protofibril forms of alpha-synuclein, the presumed neurotoxic forms of alpha-synuclein. This assay has the potential of becoming the first biomarker assay that can reflect the underlying pathophysiology of disease. In a pilot study on clinical cohorts including patients with Parkinson’s disease and healthy controls, ability to measuring α-synuclein oligomer/protofibril in human cerebrospinal fluid from both Parkinson’s disease patients and healthy control has been demonstrated.
Market research in the form of in depth interviews with KOL’s have confirmed the most important potential customer, business opportunities, barriers and commercial value for a new biochemical biomarker in Parkinson’s disease.
Market research in the form of in depth interviews with KOL’s have confirmed the most important potential customer, business opportunities, barriers and commercial value for a new biochemical biomarker in Parkinson’s disease.
Parkinson’s disease is a significant burden on society and no effective treatment exists targeting the underlying process of the disease. By enabling early and more specific diagnosis of the disease, patients can be given treatment earlier thereby improving quality of life, symptom free time and the cost for society will also be lower. The development of the biomarker assay would also facilitate the development of effective disease modifying treatments benefiting all patients suffering from Parkinson’s disease.