Eisai/Bojian Aβ antibody lecanemab successfully in the treatment of Alzheimer's disease stage III and successfully slowed cognitive decline (Clarity AD study)

On September 28, 2022, Eisai / Biogen jointly announced that the Phase III Clarity AD clinical study of lecanemab anti-amyloid β (Aβ) antibody lecanemab for the treatment of mild cognitive impairment (MCI) induced by Alzheimer's disease (AD) has achieved positive key results, that is, the primary endpoint and all key secondary endpoints have been met and the results are statistically significant
.

First, the research background

Lecanemab is a humanized monoclonal antibody used to treat Alzheimer's disease that selectively neutralizes and clears the soluble and toxic β-amyloid (Aβ) aggregate that causes Alzheimer's disease neuropathy
.

Lecanemab, like the partner's previous drug, Aduhelm, is an intravenous antibody designed to remove amyloid deposits
.

Lecanemab targets aggregated forms of Aβ, including oligomers, protofibril, fibril, and amyloid aggregates
.

In previous large-scale Phase II clinical trials, Lecanemab has shown significant symptomatic improvement
.

Second, Clarity AD test

Clarity AD is a global, double-blind, placebo-controlled, confirmatory Phase III study of 1,795 patients with
early-stage AD.

The Clarity AD study reached its primary endpoint, with a 27%
reduction in the combined clinical dementia score (quantification of various severities of dementia symptoms, CDR-SB) in patients in the lecanemab-treated group compared to placebo.

All key secondary endpoints also achieved highly statistically significant results compared to placebo (p<0.

Eisai will present the results of the Clarity AD study at the Alzheimer's Congress Clinical Trials (CTAD) on November 29, 2022, and publish the findings in a peer-reviewed medical journal
.

In July 2022, the FDA accepted Lecanemab's Biologics License Application (BLA) through the accelerated approval route and granted priority review
.

Eisai has lecanemab global development and regulatory powers, Eisai / Biogen is jointly responsible for commercializing and promoting lecanemab and Eisai has the final decision-making power
.

Third, lecanemab brain swelling adverse reactions are mild

The incidence of brain swelling side effects associated with antiamyloid therapy was 12.

Peterson says side effects are much lower than Aduhelm and "certainly tolerable
.

Aduhelm's approval is a rare bright spot for Alzheimer's patients, but critics are calling for more evidence that amyloid-targeted drugs are worth the cost
.

Fourth, the previous listing of Aβ antibody Aduhelm (aducanumab) of Bojian/Eisai Company has been controversial and has not been approved by doctors

On June 7, 2021, the FDA announced the approval of Bojian/Eisai Company's Aβ (β amyloid) antibody Aduhelm (aducanumab) for the treatment of patients with early-stage Alzheimer's disease (AD) Biological
Product Licensing (BLA).

However, the drug has been controversial since its listing, and negative news has emerged in an endless stream
.

V.
Expert evaluation: epoch-making value

Dr.
Jeff Cummings, director of the Chambers-Grandi Center for Transformative Neuroscience at the University of Nevada, Las Vegas, said, "If you can slow down the disease by nearly 30 percent, that's great
.
That's what
we've been looking for.
”

The so-called amyloid hypothesis has been challenged by some scientists, especially after
the U.
S.
Food and Drug Administration controversially approved Aduhelm in 2021 based on Aduhelm's plaque removal ability rather than proving it helps slow cognitive decline.
The decision was made after the FDA's own panel of external experts opposed the
approval.

Eisai's deputy chief clinical officer, Michael Irizarry, said on a conference call that the company would discuss
Lecanemab's coverage with health insurance agencies.

According to the Alzheimer's Association, the number of Americans with Alzheimer's is expected to increase from more than 6 million today to about
13 million by 2050.
Globally, this number could rise to 139 million
by 2050 without an effective treatment, according to Alzheimer's Disease International.

Other plaque-targeted antibodies in the late stages of development in Alzheimer's disease patients include gantenerumab of Roche Holdings (ROG.
S) and donanemab of Eli Lilly
.

Biogen/Eisai is dead in Alzheimer's disease, and the exploration process can be described as a hundred twists and turns
.
Aducanumab obtained FDA approval based on controversial data, but failed to get doctors' approval, and sales were dismal
after listing.
The data of Lecanemab's Phase III clinical trial may lead the Aβ theory to a new era, and will also bring the gospel to the
majority of Alzheimer's patients.

Resources:

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