Clinical data obtained using a newly developed assay confirms high correlation between saliva and blood for measurement of Natalizumab (Tysabri) as well as the hypothesis that transformation of the drug in to less potent form varies between individuals.

Natalizumab is highly effective at improving outcomes in people with active relapsing-remitting multiple sclerosis. Once administered, natalizumab can transform to a less potent form but the extent to which this occurs varies between individuals. At ACTRIMS 2023, AegirBio presented clinical data obtained using newly developed assays that distinguish between the two forms of the drug. As increased levels of the more potent form of the drug may be linked to a rare but very serious brain infection, distinguishing between the potent and less potent forms of natalizumab is critical when considering dosing schedules. Our data confirmed the hypothesis that the concentration of immunoglobulin subclass IgG4 in patient serum greatly influences the proportion of potent to less potent drug. Furthermore, our data demonstrated that levels of therapeutic drugs in saliva have high correlation to levels in serum. The use of saliva to monitor drug levels will help to make personalized dosing accessible, easily implementable, and potentially improve patient outcome. 

“These are results we are very proud to present. The correlation between saliva and blood opens new opportunities in monitoring disease and treatment. When looking at the individual variation in transforming the drug in to more or less potent forms, and the possible effect of this, I believe that this is the essence of personalised medicine”, says Dr Bradley Messmer, CEO AegirBio

About Aegirbio

Aegirbio is a Swedish diagnostics company offering tests to monitor and optimize the dosing of biological drugs by means of a unique, patented technology platform. Biological therapies is the fastest growing segment of the pharmaceutical industry; a quarter of all drugs are projected to be biological in 2020. At the same time, drug concentrations vary tremendously (up to 100 times) in patients that receive biological drugs in standard doses.

The result of this one size fits all-approach is that patients with low drug concentrations do not respond to treatment, while excessive drug concentrations increase the risk of adverse effects in others. The uncertainty surrounding dosing results in overdosing or underdosing in about 55 percent of the cases, which causes unnecessary costs and suboptimal clinical outcomes.

The Company's tests for optimal dosing of biological drugs will be focused on neurological disorders, autoimmune diseases and cancer. In the first quarter of 2020, Aegirbio initiated sales in the U.S. of the MoNATor test for the drug Tysabri, which is used for treatment of the neurological disorder Multiple Sclerosis (MS). Aegirbio’s goal is to launch a total of four tests before 2023. Diagnostics will be offered through laboratory testing as well as in the form of a P.O.C. (Point of Care) test for use in hospitals and health centres. The plan further includes P.O.N. (Point of Need) tests for use at home.

For more information, please visit Aegirbio’s website, www.aegirbio.com

Certified adviser for the company is Eminova Fondkommission AB  | +468-684 211 00 | info@eminova.se

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