Biogen, Eisai Alzheimer's candidate lecanemab meets primary endpoint in late-stage trial
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Lecanemab, a closely watched Alzheimer's biologic drug in development from Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALY), met its primary endpoint in a phase 3 trial.
The antibody, which targets amyloid beta plaque in the brain, is under investigation for mild cognitive impairment due to Alzheimer's disease and mild forms of the disease.
In the Clarity AD trial of ~1800 patients with early Alzheimer's, lecanemab reduced clinical decline on the global cognitive and functional scale (CDR-SB) by 27% compared to those on placebo at 18 months, meeting the primary endpoint, according to a top-line readout.
The companies noted that as early as six months after beginning dosing, those in the treatment group demnonstrated statistically significant changes in CDR-SB from baseline compared to the placebo group.
Also, key secondary endpoints were met. These include ey change from baseline at 18 months compared with placebo of amyloid levels in the brain, the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), and the AD Composite Score (ADCOMS).
However, results also showed that the incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group compared to 1.7% in the placebo group.
Eisai said it plans to submit applications on lecanemab to regulators in the US, Europe, and Japan by the end of its 2022 fiscal year, which is March 31, 2023.
Read Seeking Alpha's contributor Sage Advisors' assessment of how positive lecanemab data can lead to growth for Biogen (BIIB).