Firm behind experimental Alzheimer's drug makes case for approval
08 December, 2019
A U.S. pharmaceutical company behind an experimental Alzheimer's drug presented new results on Thursday, seeking to restore confidence in the resurrected medicine months after halting clinical trials because it had appeared to have failed.
Biogen presented the new data at a research conference in San Diego, and argued that in one of the two trials, an analysis of the data showed its drug aducanumab was in fact effective in reducing cognitive decline in patients at a higher dose.
Aducanumab attracted significant attention in 2016 during early testing, raising hopes that a treatment may finally be within reach for the memory- and independence-robbing disease.
The monoclonal antibody aims to dissolve the build-up of a protein, beta-amyloid, in the brain tissue of Alzheimer's patients. This is one of the three main avenues being explored by researchers against the disease.
The company continued its testing in placebo-controlled clinical trials involving more than 3,000 patients in 20 countries before halting the studies in March because the drug did not appear effective.
But it changed its mind in October, announcing it had new data.
According to the presentation shown Thursday, the intravenous medicine slowed the rate of cognitive decline for patients on the drug by 23 percent compared to a placebo, as measured by their responses to a questionnaire. It also slowed the rate of loss of autonomy by 40 percent.
Response was mixed among experts in the field, with some welcoming the new data and others cautioning that more scrutiny is required if the drug is to pass regulatory muster with the US Food and Drug Administration (FDA).
"This is an important announcement showing that an antibody targeting the build-up of amyloid in the brain results in a meaningful reduction in the speed of decline as measured by memory/thinking skills loss but also crucially how well individuals manage day-to-day tasks," said Ivan Koychev, senior clinical researcher at Dementia Platform UK.
But James Pickett, head of Britain's Alzheimer's Society, said: "Following the results presented today, it's not possible to be sure whether people in the early stages of Alzheimer's disease would meaningfully benefit from aducanumab. "The drug company is collecting more data which may help further answer this question over the coming months."
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