An experimental Alzheimer’s drug therapy has slowed cognitive and functional decline by 27% versus placebo in a double-blind, randomized study of 1,795 individuals with early signs and symptoms of the disease.
Pharma partners in the R&D project Eisai of Tokyo and Biogen of Cambridge, Mass., announced the potential breakthrough Sept. 27.
For the trial—a phase 3 confirmatory study—patients took either the drug, called lecanemab, or a placebo before undergoing brain imaging at the 18-month mark.
Along with the efficacy results, the companies report encouraging findings on safety.
Minimally Troublesome Side Effects
Lecanemab is in the category of IV-administered antibodies that target and scrub brain amyloid. Eisai and Biogen note that such anti-amyloid compounds are known to cause adverse events called amyloid-related imaging abnormalities (ARIAs). These come in two types, the companies explain in the announcement.
ARIA-E, for effusion, usually presents as temporary swelling of the brain.
ARIA-H, for hemorrhage, is seen as small bleeds in or on the surface of the swollen brain.
In the trial, the incidence of all ARIA (ARIA-E and/or ARIA-H) evident on imaging was 21.3% in the lecanemab group and 9.3% in the placebo group.
However, lecanemab corresponded with symptomatic ARIA-E—the symptoms being either headache, confusion, dizziness, vision changes or nausea—at a rate of only 2.8% (vs. 0.0% with the placebo).
Meanwhile the incidence of symptomatic ARIA-H was just 0.7% in the lecanemab group and 0.2% in the placebo group.
Amyloid Hypothesis Back in the Headlines
The companies are now seeking regulatory approval in the U.S. through the FDA’s Accelerated Approval Pathway and expecting a decision by early January.
As for the dynamics of the partnership, Eisai “serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority,” the Sept. 27 announcement states.
Also in the announcement, Eisai CEO Haruo Naito says the trial’s results “prove the amyloid hypothesis, in which the abnormal accumulation of amyloid beta in the brain is one of the main causes of Alzheimer’s disease. … Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options.”
Biogen CEO Michel Vounatsos adds that the trial’s findings give patients and their families “hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function. Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease.”
Lecanemab follows and evidently improves upon the partnership’s earlier entry in the anti-amyloid market, the widely discussed and disputed Aduhelm (generic name aducanumab).
The full lecanemab announcement is here, and the development has drawn quick coverage from the consumer and general business press, including from Reuters, Bloomberg and USA Today.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.