An estimated 5.8 million people living in the US have Alzheimer’s disease. Currently, no cure is available and any drugs have only been able to treat its symptoms. Now however, in a surprising take, drug company Biogen has announced that their drug, Aducanumab, previously declared failure in March 2019, may be able to slow down the disease’s progression.
Designed to target amyloid-beta plaques, a build-up of toxic proteins commonly thought to cause the neurodegeneration seen in Alzheimer’s, an earlier independent analysis of the drug found it to be ineffective in tackling the condition’s progression. It turns out however that the datasets analyzed by this study only comprised of data points until December 2018, whereas the trials continued until March 2019.
Thus, upon analyzing the datasets made until March, in which patients received higher doses of the drug, the researchers noted significantly slower rates of cognitive and functional decline when compared to a control group.
Al Sandrock, the head of research and development at Biogen said, “I have to pinch myself because I almost don’t believe it yet...In retrospect, the results of the futility analysis was incorrect. That’s because it was from a smaller dataset that looked at patients with less exposure to high dose aducanumab (Herper: 2019).”
Bart De Strooper, from the UK Dementia Research Institute said, “It is encouraging for the field that the tremendous work delivered to target amyloid beta appears to be validated in this trial and we should now redouble our efforts to tackle this central problem in Alzheimer’s Disease, alongside other important contributors (Hariday: 2019).”
Despite this optimism however, some are yet to be convinced. Nikolaos Robakis for example, a skeptic of the amyloid hypothesis and neuroscientists at the Icahn School of Medicine at Mount Sinai in New York City said, “Why [Biogen] came back now and said they would pursue what before they themselves they tried to discard – it seems, to me, strange.”
This comes alongside his proposal that rather than being causes of neurodegeneration, beta-amyloid plaques are consequences of an underlying vulnerability to stress in the brain (Wadman: 2019).
Although Biogen has yet to release comprehensive data about its two Phase 3 trials, it claims that the decision to continue Aducanumab’s development come from direct consultations with the FDA. Currently, they plan on filing an application for its approval in early 2020.
Sources
Hariday, Rich: New Atlas
Herper, Matthew: Stat News
Wadman, Meredith et al.: Science
