Christian company and partner Biogen Inc. said their drug has slowed significantly Alzheimer’s diseaseIt is the first drug to blunt the progression of the most common dementia in a definitive, large-scale trial.
Lecanumab reduced the rate of cognitive decline by 27% in people with early disease over 18 months compared to placebo, which meets the main goal of the trial, the companies said in a statement. The benefits came with side effects, including brain swelling and bleeding, although serious cases were rare.
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The result is a major milestone for researchers who have been trying in vain for decades to stop the drastic decline associated with the disease. How much difference this will make to patients and families is less clear. Although it appears to apparently slow the disease, the drug does not restore mental ability or completely stop its loss.
“This area is expected to improve, and should result in favorable regulatory actions,” said David Knopman, a clinical neurologist at the Mayo Clinic in Rochester, Minnesota.
caution note
“However there is an important caveat note: the magnitude of the delay – which was the slowing rate of the decline – was small,” he said. “We can only hope that the benefits are sustainable and may increase over time. Those long-term properties are unknown at this time.”
Christian was not traded in Tokyo at its upper limit as bids offered more than 19 times. Eli Lilly & Co., which is developing a similar drug, rose 6.7% in the US after Tuesday’s trading. Biogen’s shares were halted. The drug was originally licensed from Bioarctic AB in Sweden.
The Alzheimer’s Association welcomed the results, saying they were the most encouraging findings ever from drugs aimed at treating the underlying cause. disease, The group said lecanemab has the potential to change the course of the disease and help people maintain their abilities, remain independent and participate fully in daily life.
Pharmaceutical and biotechnology analysts were equally fast.
“We finally have a clean victory in Alzheimer’s disease,” Ivan David Seegerman, an analyst at BMO Capital Markets, wrote in a note to clients. “The top-line data are clear to us – lecanumab slows the rate of cognitive decline.”
The test met every target, including other measures of mental function and ability to perform daily activities, the companies said.
Lecanemab is already being reviewed by US regulators under a special “expedited approval” route. The companies said they would apply for full US approval by the end of March, which could eventually lead to broader coverage by the Medicare Insurance Program for the Elderly. The companies plan to file in Europe and Japan at the same time.
There were some serious side effects. The study included 1,795 patients, of whom 21.3% experienced brain swelling or cerebral hemorrhage, compared with 9.3% of patients on placebo. While the majority of cases were asymptomatic, 2.8% of people on lecanumab had symptomatic encephalitis, the companies said.
amyloid hypothesis
Lecanemab is the latest in a long line of drugs designed to remove amyloid, a toxic protein that clutters the brain and is a hallmark of Alzheimer’s disease. Several previous trials of amyloid-lowering drugs have failed or have given mixed results.
The results strengthen the amyloid hypothesis: a long-held but controversial theory that amyloid builds up over time is one of the main causes of disease. The success is expected to raise hopes for other anti-amyloid drugs in development, including drugs from Roche Holding AG and Eli Lilly in end-stage trials.
Isai’s chief executive officer Haruo Naito said in a statement that the “results” prove the amyloid hypothesis.
The positive study isn’t the end of the challenges for Isai and Biogen, which are collaborating on a drug that had some initial controversy and will split the profits.
A previous drug they developed together, called Eduhelm, was approved in the US in June 2021 despite conflicting test results. While the amyloid-lowering antibody modestly slowed the decline from Alzheimer’s in one large trial, another showed no effect. Both were quickly stopped. But the Medicare program for the elderly refused to pay for the drug that initially cost $56,000 a year outside of clinical trials, and it ended up being a commercial failure.
Based on the results of the study, lecanumab is likely to receive full US Food and Drug Administration approval, said Lon Schneider, a professor of psychiatry and behavioral science at the University of Southern California. However, this is not the end of the discussion.
“The debate is going to be about the smaller effect size” and whether it is clinically meaningful, Schneider said in an interview.
Other questions remain, including reimbursement and potential rivals. Jefferies analyst Stephen Barker said the success would increase confidence about the potential of competing candidates, which would complicate investors’ outlook on the commercial opportunity.
Roche said it was encouraged to learn about positive results before amyloid-targeted studies are in the third and final phase of drug development. It said data from its two major studies on the Alzheimer’s drug gentianumab will be available in the coming months.
Isai and Biogen did not release details of their study’s findings. Full results are expected to be published in a medical journal and presented in clinical trials. Alzheimer’s disease meeting in November. Roche’s gantenumab study is expected to be presented there as well.
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