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AegirBio announces first clinical saliva TDM study in US

PRESS RELEASE                      October 14, 2022 AegirBio is pleased to announce the initiation of a clinical study to evaluate saliva based measurements of natalizumab in multiple sclerosis patients. The goal of the study is to confirm that our novel saliva calibration method can be used to accurately measure therapeutic drug levels in saliva as compared to blood. The study is being performed in collaboration with Dr. John Foley at the Rocky Mountain MS Clinic in Salt Lake City.

“To our knowledge, this is the first such study of its kind and will hopefully open the door to non-invasive sampling for TDM, for natalizumab and across the whole portfolio of biologics we measure. There is great potential for at-home sampling or even self-testing with POC tests we are positioned to be the pioneers in this segment, leveraging our unique technologies and knowhow”.

The study is set to run through the next few months and enroll up to 100 patients. The results will be published thereafter. We are also actively seeking addition clinical collaborations for other drugs in our test menu, notably infliximab and rituximab.

Alongside to the above study, AegirBio is pleased to announce that the article “Peptide Mimotope-enabled Quantification of Natalizumab Arm Exchange during Multiple Sclerosis Treatment” has been accepted for publication in the Therapeutic Drug Monitoring journal. (Page LJ, Lagunas-Acosta J, Heussen R, Castellana ET, Messmer BT. Peptide Mimotope-enabled Quantification of Natalizumab Arm Exchange during Multiple Sclerosis Treatment. Ther Drug Monit. 2022 Oct 6. doi: 10.1097/FTD.0000000000001038. Epub ahead of print. PMID: 36201847.)

In this article we describe the development of an assay that can distinguish between and quantify bivalent (unexchanged) and monovalent (exchanged) forms of natalizumab in clinical samples. Thus we continue to develop the next generation of tools for effective TDM of this important therapeutic.

About AegirBio

AegirBio is a Swedish diagnostics company that was founded in 2019 to offer tests to monitor and optimize the dosage of biological drugs via its unique patented technology platform. In June 2020, AegirBio was listed on the Nasdaq First North Growth Market. The company's ambition is, in addition to bringing innovative diagnostic technology to the market, to make diagnostics more accessible, easier to use and to provide accurate and easily transferable results.

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