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Eli Lilly’s experimental drug Donanemab slowed the progression of Alzheimer’s disease by 60% for patients in the early stages of the brain-wasting disease, according to trial data presented at a medical meeting Monday.
For these patients, the drug slowed cognitive decline at about twice the rate reported by Lilly in May for the trial’s overall treatment group. The full analysis showed that the results were less robust for older patients in the later stages as well as those with higher levels of a protein called tau that is linked to the development of Alzheimer’s disease.
The findings confirm that “early detection and diagnosis can really change the course of this disease,” said Ann White, chair of neurology at Lilly.
The study showed that brain swelling, a known side effect of drugs such as dunanimab, occurred in more than 40% of patients with a genetic predisposition to Alzheimer’s disease.
The company had previously reported that 24% of the overall Donanemab treatment group had brain swelling. Cerebral hemorrhage occurred in 31% of the donanimab group and approximately 14% of the placebo group.
The researchers said that the deaths of three patients who underwent the trial were related to the treatment.
“These side effects should not be taken lightly,” said study researcher Dr. Liana Apostolova, MD, a professor of Alzheimer’s research at Indiana University School of Medicine, but in most cases it could have been controlled with monitoring with magnetic resonance imaging (MRI) or stopping the medication.
It said doctors would likely use “a very rigorous MRI safety check while treating these patients.”
Donanemab, like Biogen’s recently approved Eisai and Leqembi, is an intravenous antibody designed to remove deposits of a protein called beta-amyloid from the brains of Alzheimer’s patients.
Over the course of the 18-month trial, Lilly said, the effect of the dunanimab treatment continued to increase compared to the placebo, even for participants who were weaned off the drug after their amyloid levels dropped too low.
“At the end of the trial, the average patient had been without medication for seven months and yet continued to benefit from it,” White said.
She said the findings support the idea that donanimab can be stopped once the amyloid has been cleared from the brain.
“Within the next year or two, we may be able to offer patients a combination of therapies that slow the progression of Alzheimer’s disease. Some patients did not significantly worsen during the trial, and on average some patients did not get worse,” said Dr Liz Coulthard, associate professor of neuroscience at the University of Bristol. The progression of the disease slowed from 4.4 to 7.5 months over the course of 18 months.
The study met all its goals, Lilly said in May, showing that dunanimab slowed cognitive decline by 29% compared to a placebo in 1,182 people with mild cognitive impairment or mild dementia whose brains had deposits of two key Alzheimer’s proteins, They are beta-amyloid and tau.
For patients with high tau, dunanimab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low to moderate tau levels.
The full study results were presented at the Alzheimer’s Association International Conference in Amsterdam and published in JAMA.
“Whether the harms of these drugs are balanced by their modest clinical benefits will ultimately require more data,” said an editorial in JAMA alongside the study.
Lilly expects the FDA to decide by the end of this year whether to approve donanemab. She said applications to other global regulators are ongoing, most of which will be completed by the end of the year.
This month, the U.S. Food and Drug Administration granted standard approval to Leqembi, the first modified treatment for Alzheimer’s disease to achieve this goal, paving the way for broader insurance coverage of the drug.
Both drugs are also being studied in large trials to see if they have an effect on delaying the onset of Alzheimer’s symptoms.
More than 6 million Americans are living with Alzheimer’s disease, and that number is expected to increase to nearly 13 million by 2050, according to the Alzheimer’s Association.
Shares of Lilly, which hit an all-time high near $469 in June, are down half a percentage point at $447.28 in early trading on the New York Stock Exchange.
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