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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

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