Alzheimer’s drug resurrected, as company claims clinical benefits
Biogen shocked investors and scientists today, announcing the resuscitation of an Alzheimer's disease drug it had declared ineffective in March; the company plans in early 2020 to ask the U.S. Food and Drug Administration to approve the commercialization of aducanumab, an antibody designed to bind and eliminate beta-amyloid protein in the brain.
An Alzheimer's drug would be effective according to Biogen
As the STAT report indicates, Biogen states that this reversal occurred after evaluating clinical trial data from more patients than it had previously done. While an initial analysis of data from two clinical trials revealed that this drug had failed to significantly slow the progression of early-stage Alzheimer's disease.
The company now concludes that, mainly because of the responses of people receiving the higher of the two doses of antibodies, this drug has significantly slowed the cognitive and functional decline of people, which means their ability to cope with the daily activities of life.
The first Biogen analysis used data from 1,748 patients who received a low or high dose of the drug for 18 months; the new analysis, whose underlying data are not yet publicly available or described in a journal article, included 2,066 of these patients.
The Alzheimer's Association of Chicago, Illinois, said it was "encouraged" by the announcement. "We look forward to reviewing a full report of the results," she said in a press release.
Bart De Strooper, who heads the British Institute for Dementia Research at University College London, called the story "fantastic". We currently have no effective treatment to slow or stop the progression of Alzheimer's disease and I hope this is a turning point.
"He also suggested that these results could revive the once dominant theory that neurodegenerative disease is largely due to the brain's accumulation of toxic amyloids. "We should now redouble our efforts to address this central problem of Alzheimer's disease."
Evaluate the antiamyloid theory Biogen's announcement comes as researchers discuss the therapeutic prospects of Alzheimer's disease at the Society for Neuroscience's annual meeting in Chicago. "It's very interesting," says neuroscientist Weiming Xia of Boston University Medical School.
If aducanumab is approved, researchers will be able to evaluate the amyloid strategy in a much larger group of patients and identify the sub-populations that are most likely to benefit, says Xia. "If you use a single antibody for all Alzheimer patients, it won't work."
Other participants at the meeting remained sceptical about the efficacy
of this drug and the underlying amyloid hypothesis. "Why Biogen has come back now and said she will pursue what he was trying to reject before she did, which seems strange to me," says Nikolaos R
obakis, a neuroscientist at the Icahn School of Medicine in Mount Sinai, New York City.
Researchers do not believe in the beta-amyloid and tau hypothesis
In a presentation today, Robakis proposed that beta-amyloid plaques - and another characteristic of Alzheimer's disease, the accumulation of tau proteins in neurons - are not causes of neurodegeneration, but consequences of a fundamental vulnerability to stress in the brain. Already, he says, the failures of other trials that have taken the anti-Amyloid strategy suggest that "the evidence is against it".
Biogen intends to reveal more details on its latest analysis at a future scientific conference.
