Eisai and Biogen present full results for Lecanemab phase 3 study in AD

Eisai Co (ESALY) and Biogen (BIIB) "announced that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease, or AD, and mild AD with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer’s Disease conference, in San Francisco, California and virtually. Mean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45, representing a 27% slowing of decline. Starting as early as six months and increasing in absolute difference over time across all time points every 3 months, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo. All key secondary endpoints also showed highly statistically significant results compared with placebo. In the amyloid PET sub-study, treatment with lecanemab showed statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months. Mean change in Centiloids at 18 months was -55.5 and 3.6 for lecanemab and placebo groups, respectively. Lecanemab slowed decline of cognitive function by 26% on ADAS-Cog14 at 18 months n the ADCOMS assessment, lecanemab slowed disease progression by 24% at 18 months. Lecanemab slowed decline of activities of daily living by 37% on ADCS MCI-ADL at 18 months. In addition, the primary stratified analysis showed consistent results in CDR-SB, ADAS-Cog14 and ADCS MCI-ADL at 18 months of treatment with lecanemab in all subgroups of disease stage, ApoE4 status, presence or absence of concomitant approved AD symptomatic medication, and region."