Multiple Sclerosis (MS)
Multiple Sclerosis (MS) is a chronic, inflammatory autoimmune condition in which the immune system attacks the central nervous system. This leads to the degeneration of the myelin sheath protecting the nerves of the brain and spinal cord.
Strategies to diagnose MS
There is still no known cure for MS or any in-vitro diagnostic tests available for confirming the disease or differentiating it into informative subtypes. As such, the average time between the first onset of clinical symptoms and obtaining a confirmed diagnosis is greater than 3 years.
Treatment of MS using immune modulating and/or disease modifying drugs only slows disease progression and reduces the effects of disabling symptoms. Earlier treatment is therefore highly desirable to reduce patient suffering (and lifelong treatment costs).
We have been working alongside Clinic Lüdenscheid, Department of Neuroimmunology in Germany to identify novel autoantibodies in MS patient serum. We are now exploring their potential as the basis for a new diagnostic tool that would allow for more accurate MS identification and monitoring, enabling more informed treatment strategies and better disease management.
The challenges of MS diagnosis and the need for new tests
There is an unmet need for tools that can diagnose MS with a high degree of specificity and sensitivity, particularly those that can reliably exclude alternative diagnoses. Early diagnosis during the pre-symptomatic phase remains especially difficult, as the currently favored approach of MRI testing cannot detect lesions at his stage. Cerebrospinal fluid analysis can allow the exclusion of other diseases that could masquerade as MS via the detection of an abnormal IgG index. Blood samples are also screened for anti-nuclear antibodies (ANA) to look for autoimmunity. However, the presence of ANA is not specific to MS patients and can also be found in patients suffering from chronic infections and cancer.
In an effort to design diagnostic tests that provide much needed insight early during disease development, we are currently assessing the feasibility of detecting MS specific autoantibodies to determine which patients require rigorous clinical follow-up (e.g. cerebrospinal fluid analysis). We’re currently validating the approach via a multi-center trial conducted together with the Accelerated Cure Project for Multiple Sclerosis (USA), Technical University Munich, Department of Polyclinic (Europe) and Karolinska Institute (Sweden).
New tools to support MS drug development
About 2-2.5 million people were affected globally by MS in 2010, resulting in an estimated 18,000 deaths. This highlights the importance of developing new diagnostic tools and drug treatments for the disease.
MS is very difficult to diagnose during the early stages of disease development, an unfortunate fact given that this is a key window for treatment. Novel diagnostic tools capable of detecting MS earlier following onset would be invaluable for developing new drugs, while better patient stratification to identify those patients most likely to benefit from treatment would increase the chances of successfully achieving regulatory approval.
The detection of autoantibodies provides a means of detecting the occurrence of disease before the onset of classical clinical symptoms. Our proprietary autoantibody discovery platform puts us and our Pharma partners in an excellent position to co-develop novel CDx tests alongside new drugs for treating MS. To find out more information on how our technology could help support your drug development program, get in touch now.