© Reuters An Alzheimer’s patient rests on a bench after a walk at the Ville Ladais Alzheimer’s site in Dax, France, September 24, 2020. Image taken on September 24, 2020. REUTERS/Gonzalo Fuentes/File Photo
By Deena Beasley and Julie Steenhuysen
(Reuters) – Essay Co Ltd and Biogen Inc (NASDAQ: NASDAQ) said on Tuesday that an experimental Alzheimer’s drug significantly reduced cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare victory in a wasteland. Unsuccessful drugs.
The drug lecanumab reduced the progression of the brain-wasting disease by 27% compared to a placebo, meeting the study’s primary goal and offering hope to patients and their families seeking effective treatment.
“It’s not a huge result, but it’s a good result,” said Ronald Peterson, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota.
The race to slow the progression of Alzheimer’s comes as the number of Americans living with the disease is expected to roughly double to 13 million by 2050, according to the Alzheimer’s Association.
At the international level, this figure is Alzheimer’s International says it could reach 139 million by 2050 without effective treatment.
Eisai shares jumped 17% to their daily limit in Tokyo, while Biogen shares rose 46% in premarket trading.
Esai, the 50-50 partner leading the lecanumab program, is seeking FDA approval on an expedited basis, with a decision expected in early January.
Eisai is aiming to fully approve and market the drug in the United States, Europe and Japan by the end of 2023, CEO Haruo Naito told reporters in Tokyo.
The company said results from an 1,800-patient trial showed that removing sticky deposits from the brains of people with early Alzheimer’s disease, a protein called amyloid beta, could slow the progression of the debilitating disease.
Lecanemab’s data suggests “a potential new multibillion-dollar franchise,” Jefferies analyst Michael E. said in a research note.
‘Very early days’
Lecanumab, like its fellow former drug Aduhelm, is an intravenous antibody designed to remove amyloid deposits. Unlike Aduhelmin, lecanumab targets forms of amyloid that have not yet aggregated.
“If you can slow disease by about 30 percent, that’s great,” said Dr. Jeff Cummings, director of the Chambers-Grundy Center for Transformational Neuroscience at the University of Nevada, Las Vegas.
The so-called amyloid hypothesis has been challenged by some scientists, most notably the U.S. Food and Drug Administration’s Aduhelm in 2011. The decision comes after the FDA’s own panel of outside experts began challenging approval.
Dr. Kristian Steen Frederiksen, director of the clinical trials unit at the University of Copenhagen, said that while the top-line results of lecanumab are convincing, it is still “very early days” to determine whether the harm is clinically meaningful.
“Alzheimer’s is a very complex disease and amyloid-related pathology cannot be the only player,” he said. “So targeting one target doesn’t produce large effect sizes.”
Aduhelmin is the first new Alzheimer’s drug to be approved in 20 years after a long list of high-profile failures for the industry.
Patient advocacy groups hailed the news of the positive licanemab trial results.
“I hope the FDA approves the drug in January,” said George Vradenberg, chairman of USAAgainst Alzheimer’s.
A phase III trial evaluated the drug’s ability to reduce cognitive and functional decline. judgment and problem solving and personal care.
The rate of cerebral edema, a side effect associated with anti-amyloid treatments, was 12.5% in the lecanumab group and 1.7% in the placebo group. But many cases did not develop symptoms, with symptomatic brain swelling occurring in 2.8% of those in the lecanumab group, the companies said.
Minor bleeding in the brain occurred in 17% of the licanumab group and 8.7% of the placebo group.
Peterson said the side effects are much lower than Aduhelm and “definitely tolerable.”
AduHelm’s approval was a rare bright spot for Alzheimer’s patients, but critics called for more evidence that drugs that target amyloid are worth the cost.
Controversy and the reluctance of some payers to cover Adduhelm led Biogen to drop the price of the drug to $28,000 a year from $56,000.
Medicare, the U.S. government’s health plan for people age 65 and older, said this year it will only pay for Aduhelm and other similar drugs if patients are enrolled in a valid clinical trial, which has greatly reduced the drug’s use.
Michael Irizarry, Esai’s deputy chief clinical officer, said on a conference call that the company will discuss lecanumab coverage with Medicare.