New partnership aims to develop clinical tools for motor neurone disease prognosis, monitoring, and drug development

New partnership aims to develop clinical tools for motor neurone disease prognosis, monitoring, and drug development

LifeArc and ALS Therapy Development Institute (ALS TDI) have joined forces to identify, validate, and develop new biomarkers that are crucial for ALS/MND prognosis and drug development. 

The collaboration will focus on validating MMP-9 and TIMP-1 as minimally invasive biomarkers for ALS, and the research will use serum and plasma samples from people living with ALS, through the ALS Research Collaborative (ARC) study. By correlating the levels of these biomarkers with longitudinal and cross-sectional clinical data, the project aims to develop a kit for use in both clinical and research settings for prognosis and potential monitoring of the disease. Analysing the protein levels in these samples, along with other clinical data from the study, will enable the team to determine the utility of MMP-9 and TIMP-1, and other protein analytes.

The project is part of LifeArc’s MND Translational Challenge, and it will run for two years.  Under the terms of the collaboration, LifeArc will have the exclusive option to further develop the project’s outputs, leveraging its translational and diagnostic development capabilities. 

Dr Manuela Cerina, Scientific Director of Neurodegeneration at LifeArc, said, “Diagnostic and prognostic biomarkers for MND/ALS are a needed tool for patient care and would offer crucial insights for clinical research and drug development. Currently, we rely on non-specific biomarkers common to different neurodegenerative diseases due to a lack of validated biomarkers specific for MND/ALS and a lack of consensus among researchers. Recent evidence shows that high or low plasma levels of Matrix Metalloproteinase 9 (MMP-9) and Tissue Inhibitor of MetalloProteinases 1 (TIMP-1), proteins significantly correlate with ALS progression and severity.  These biomarkers can be measured from blood plasma and serum, keeping the testing minimally invasive for the patients.” 

ALS TDI is a U.S based non-profit biotech company committed to accelerating the discovery and development of treatments for ALS.  The organisation shares similar goals with LifeArc, aiming to bring about meaningful advances in research to improve the lives of people affected by the condition. 

"We're so pleased to partner with LifeArc on this groundbreaking initiative to explore potential blood-based prognostic biomarkers for ALS," said Fernando Vieira, M.D., CEO and CSO of ALS TDI. "By leveraging our extensive clinical data and biosample resources through the ALS Research Collaborative (ARC) study, and combining them with LifeArc’s expertise in translational science and diagnostics, we aim to significantly advance our understanding of ALS prognosis and disease monitoring.”

To corroborate initial findings and further validate the association between MMP-9 and TIMP-1 and the disease, ALS TDI, through its ALS Research Collaborative (ARC) study, has obtained longitudinal serum and plasma samples from people living with ALS which will be processed to assess the protein levels of MMP-9 and TIMP-1 alongside other 7000 analytes. With the support of LifeArc’s Data Science Team, results will be analysed and correlated with patient clinical data obtained from the ARC study, like disease onset and duration as this will allow to determine the use of MMP-9 and TIMP-1 and other protein analytes as prognostic biomarkers of disease or potentially for disease monitoring. Upon confirmation of these results, ALS TDI, in collaboration with the Diagnostic team at LifeArc aims at developing an ELISA kit to assess the levels of MMP-9, and TIMP-1 and other biomarkers in clinical and research settings.

Dr Thorston Forster, Scientific Director for Clinical Date, Machine Learning and AI at LifeArc says, “Alongside providing financial support, LifeArc prioritises contributing hands-on laboratory science and data science expertise to translational projects. With the ALS-TDI study aiming to move scientific insights closer to actual benefit for individuals with this life-changing condition, our Data Sciences team is delighted to be able to support this effort with advice on statistical study design and analysis.”