US pharmaceutical giant Eli Lilly announced on Wednesday that its experimental Alzheimer’s drug significantly slowed cognitive and functional decline, results experts called “remarkable” despite some patients experiencing serious side effects.
In an analysis of nearly 1,200 people in the early stages of the disease, donanemab slowed the progression of symptoms by 35 percent over 18 months compared with a placebo.
This was measured by cognition and their ability to perform everyday tasks such as managing finances, driving, engaging in hobbies and conversing about current events on a standardized index called the Integrated Alzheimer’s Disease Rating Scale (iADRS).
Side effects included temporary swelling in parts of the brain, which occurred in nearly a quarter of treated patients, as well as microhemorrhages, which occurred in 31 percent of patients in the treatment arm and 14 percent of patients in the placebo group.
The deaths of two participants were attributed to side effects, while a third may also have died from the treatment.
Nevertheless, the data were widely praised by independent experts who said that donanemab, if approved, has the potential to significantly improve the lives of people suffering from the most common form of dementia.
The news comes after the US approved another Alzheimer’s drug in January, Biogen and Eisai’s lecanemab, which slowed the rate of cognitive decline by 27 percent and was also hailed as a blockbuster by experts.
Biogen and Eisai also developed aducanumab, known by the brand name Aduhelm, which was approved in the US in 2021, although the decision was mired in controversy and led to an incriminating congressional report.
In addition to serious side effects, the clinical efficacy of Aduhlem has been equivocal, which has not yet been the case for the following two drugs.
Lilly said it would quickly submit its results to the US Food and Drug Administration (FDA) and other global regulators.
“We are extremely pleased that donanemab produced positive clinical results in this study with convincing statistical significance in people with Alzheimer’s disease,” Daniel Skovronsky, Lilly’s chief scientist and physician, said in a statement.
But Mark Mintun, Lilly’s senior neuroscience research and development officer, added that “as with many effective treatments for debilitating and fatal diseases, there are risks that can be serious and life-threatening.”
In Alzheimer’s disease, two key proteins, tau and amyloid beta, accumulate in tangles and plaques, collectively known as aggregates, which cause brain cells to die and lead to brain shrinkage.
Like lecanemab (also known by the brand name Leqembi), donanemab is an antibody therapy that targets amyloid beta.
Experts said the results for both drugs supported the theory that removing amyloid beta improves the course of the disease and that future therapies targeting both proteins may have even better results.
Nick Fox, of the UK’s Dementia Research Institute, said that although the full data set was not yet available, the results announced in a press release “confirm that we are in a new era of modifying Alzheimer’s disease”.
Read Now:Listening to upbeat or soothing music can help overcome motion sickness
