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Alzheimer’s drug study shows positive results in early stages of disease

Alzheimer’s drug …

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An experimental Alzheimer’s drug made by Eisai Co Ltd and Biogen slowed cognitive and functional decline in a large study of patients in the early stages of the disease, they said on Tuesday, possibly a rare win in an area linked to unsuccessful medication is littered.

Several drug companies have so far tried in vain to find an effective treatment for the brain-wasting disease that afflicts about 55 million people worldwide. A breakthrough would be a big boost for similar studies being conducted by Roche and Eli Lilly.

Referring to the Eisai-Biogen drug results announced late Tuesday night, Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Research Center in Rochester, Minnesota, said, “It’s not a big impact, but it’s a positive impact. “

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The drug lecanemab slowed disease progression by 27% compared to a placebo, meeting the study’s main goal and potentially offering hope for patients and their families desperate for an effective treatment.

The race to halt the progression of Alzheimer’s disease begins 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.

An Alzheimer’s patient rests on a bench after being treated at the Village Landais Alzheimer’s site in Dax, France, on Dec. 24, 2020.
(REUTERS / Gonzalo Fuentes)

Without an effective treatment, the number could reach 139 million worldwide by 2050, Alzheimer’s Disease International said.

Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval on an accelerated path, with a decision expected in early January.

It is aiming for full approval and commercialization of the drug in the United States, Europe and Japan by the end of 2023, CEO Haruo Naito told reporters in Tokyo.

After failing to trade on Wednesday with a spate of buy orders, Eisai shares closed at their daily limit of 1,000 yen, according to Tokyo stock exchange rules, up 17%, indicating another strong buying demand on Thursday . Biogen’s shares are up 50% in premarket trading, lifting shares of rivals Roche and Eli Lilly.

Eisai said the results of the 1,800-patient study support the long-standing theory that removing sticky deposits of a protein called amyloid beta from the brains of people with early-stage Alzheimer’s can delay the progression of the debilitating disease.

The data is a “clear win” for Alzheimer’s patients, BMO analyst Evan Seigerman said, while Jefferies analyst Michael Yee said it suggests a potentially new multi-billion-dollar franchise.

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“Very Early Days”

Lecanemab, like the partners’ previous drug Aduhelm, is an intravenous antibody designed to clear amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that aren’t yet clumped together.

“If you can slow down a disease by almost 30%, that’s fantastic,” said Dr. Jeff Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas.

The so-called amyloid hypothesis has been questioned by some scientists, particularly after the US Food and Drug Administration’s controversial 2021 approval of Aduhelm on the basis of its plaque-clearing ability rather than evidence that it could slow cognitive function contributed to decay. The decision came after the FDA’s own panel of experts advised against approval.

While the top-line results for lecanemab are compelling, it’s “very early” to determine if the effects are clinically meaningful, said Dr. Kristian Steen Frederiksen, director of a clinical study unit at the University of Copenhagen.

Alzheimer’s “is an extremely complex disease, and amyloid-related pathologies are unlikely to be the only player,” he said. “Therefore, targeting a single target is unlikely to produce large effect sizes.”

Aduhelm was the first new Alzheimer’s drug to be approved for industry in 20 years after a long list of high-profile failures.

Patient advocates welcomed the news of positive results from the lecanemab study.

“I would hope that the FDA would approve the drug in January,” said USAgainstAlzheimer chairman George Vradenburg.

The Phase III study evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem solving and personal care.

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brain swelling

The rate of a brain swelling side effect associated with anti-amyloid treatments was 12.5% ​​in the lecanemab group versus 1.7% in the placebo group. However, many cases did not cause symptoms, with symptomatic brain swelling observed in 2.8% of patients in the lecanemab group, the companies said.

Microbleeds in the brain occurred at a rate of 17% in the lecanemab group and 8.7% in the placebo group.

Petersen said the side effect rate is much lower than with Aduhelm and “certainly tolerable”.

Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that drugs for amyloid are worth the cost.

Controversy and reluctance by some payers to cover Aduhelm prompted Biogen to lower the drug’s price from its original $56,000 to $28,000 a year.

Medicare, the US government’s health care plan for people ages 65 and older, said this year that Aduhelm and other similar drugs would only be paid for if patients were enrolled in a valid clinical trial, severely limiting the drug’s use.

Michael Irizarry, Eisai’s deputy chief clinical officer, said in a conference call that the company will be in discussions with Medicare about coverage for lecanemab.

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