The results from the Phase III Clarity AD trial of lecanemab (BAN2401), the experimental Alzheimer’s drug developed by Eisai Co Ltd and Biogen, were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, Eisai announced in a press release on Tuesday.
Both companies are members of the Biotechnology Innovation Organization (BIO).
Hailed by many as a landmark breakthrough in the treatment of early Alzheimer’s disease, this investigational anti-amyloid beta protofibril antibody is designed to target and clear amyloid, a protein that builds up in the brains of people with Alzheimer’s.
The initial results Eisai reported in September from the trial, which involved 1,795 patients with early Alzheimer’s disease, showed that lecanemab “reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%” and met its primary endpoint.
Simply put, it reduced memory decline among Alzheimer’s patients in the early stages of the disease.
Results show that secondary endpoints were also met during the trial – including a reduction in amyloid plaque burden – with statistically significant results compared with a placebo at 18 months.
“Lecanemab slowed decline of cognitive function by 26% on ADAS-Cog14 and slowed disease progression by 24% on ADCOMS at 18 months,” the trial’s conclusion says, and “slowed the decline of activities of daily living by 37% on ADCS MCI-ADL at 18 months.”
The findings, also published in the New England Journal of Medicine, show improvements weren’t huge, noting that “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function.” Nonetheless, this is “the most comprehensive and advanced study on Alzheimer’s patients to date,” as Time wrote.
It also brings a dash of hope and potential “beginning of the end” in the search for treatment for the Alzheimer’s community following Medicare’s decision to limit the coverage of Biogen’s Aduhelm, the first Alzheimer’s drug in nearly 20 years approved by the U.S. Food and Drug Administration (FDA).