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Failures have marked Alzheimer’s research for years. However, the new drug from biotech companies Biogen and Eisai delivers promising results in a study. Compared with alternative medicine, there is also a significant advantage.
The U.S. biotech company Biogen and its Japanese partner Eisai are raising hopes for a new Alzheimer’s drug with study data. The drug, lecanemab, significantly slowed the cognitive and functional decline in an extensive study of patients in the early stages of the disease – a rare success in Alzheimer’s research, where there are many failed drug projects.
In the pivotal phase 3 clinical trial, lecanemab slowed disease progression by 27 percent compared with a placebo. This achieved the trial’s primary goal. The two companies are now hoping for approval of the drug in the U.S. early next year. They also plan to seek permission in Japan and Europe.
“If you can slow down a disease by almost 30 percent, that’s fantastic. That’s what we’ve been looking for,” judged neurologist Jeff Cummings of the University of Nevada Las Vegas. Ronald Petersen of the Mayo Clinic in Minnesota said the effect, while not significant, was positive. Eisai noted that the results of the study of nearly 1,800 patients confirm a long-standing theory that removing deposits of the protein beta-amyloid from the brains of people with early Alzheimer’s can delay the progression of the disease. The data on lecanemab point to a “potentially new multi-billion dollar business,” Jefferies analyst Michael Yee said.
U.S. agency approves Alzheimer’s drug
Lecanemab, like the two partners’ Alzheimer’s drug Aduhelm, is an intravenous antibody designed to remove amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together. Aduhelm was the first new Alzheimer’s drug to come to market in the last 20 years after a long string of failures in the industry. Its approval in the United States, however, has been controversial. The Food and Drug Administration (FDA) had given the green light, although an advisory panel had previously spoken against it.
Since then, business with Aduhelm has been sluggish. According to the FDA, clinical trials with the drug showed a significant reduction in deposits. However, some patients experienced potentially dangerous brain swelling. Other experts expressed skepticism about whether Aduhelm can truly slow cognitive decline.
How do Alzheimer’s and dementia manifest themselves?
In the study with lecanemab, the rate of brain swelling was 12.5 percent in the group of patients who received the drug, compared with 1.7 percent in the placebo group. In many cases, however, there were no symptoms, with symptomatic brain swelling observed in 2.8 percent of patients in the lecanemab group. Mayo Clinic neurologist Petersen said the side effect rate was much lower than with Aduhelm and “certainly tolerable.”
Many drug companies have faced failures in Alzheimer’s research. Just recently, Roche’s antibody crenezumab failed in a clinical trial. Nearly 50 million people worldwide have dementia, and ten million new cases are diagnosed early. Alzheimer’s is the most common form of the disease.
Source: ntv.de, mbu/rts
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