Blog

Big news for patients and families affected by Alzheimer's Disease with the FDA approving the first new treatment in 20 years. Biogen's Aducnaumab, a monoclonal antibody, targets amyloid beta plaques in the brain which are thought to be a key driver of pathology and a hallmark of the disease.

The drug is not, however, without controversy - clinical trial results were uncertain and were halted early when initial analysis showed the drug was no better at slowing deterioration of memory and cognitive function than a placebo. However, following further data analysis Biogen concluded the drug did in fact work and that clearance of amyloid was likely to slow cognitive decline. A condition of the accelerated approval is the confirmation of efficacy through another clinical trial - however with 9 years to conduct this confirmatory trial important questions around efficacy in a broad patient pool are likely to remain unanswered for some time.

With 30 million people globally affected by Alzheimer's disease the approval of a new therapy offers hope to many, especially after the failure of hundreds of therapeutic candidates over the past decade. It is possible that identification of patients with pre-symptomatic disease through screening with serum biomarkers like neurofilament-light, phospho-Tau (pTau) 181, 231 and 217 using next-gen ultrasensitive Quanterix Simoa technologies may provide even greater benefit and prevent symptomatic disease. We look forward to the results Biogen's confirmatory trial as well as phase 3 trials of Sumifilam, a small molecule drug designed to restore normal shape and function of misfolded filament A in Alzheimer's patients. 2021 is shaping up as the best year in 2 decades for a global patient population desperate for good news. Fingers crossed.

For more information about Quanterix Soma technologies, contact us on customerservice@geneworks.com.au or read more here.