On 28 September, Eisai and Biogen announced positive top-line results from the Phase III Clarity AD trial of lecanemab (also known as BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (AD). Clarity AD was a global confirmatory Phase III placebo-controlled, double-blind, parallel-group and randomised study evaluating lecanemab in 1,795 people with mild cognitive impairment due to AD or mild AD dementia with confirmed amyloid accumulation in the brain. Participants from US, Australia, Canada, China, Europe and Japan received either lecanemab (10 mg/kg) or placebo biweekly via an intravenous infusion. Top-line results revealed that the study met its primary endpoint, showing a significant reduction of cognitive decline on the global cognitive and functional scale, CDR-SB, by 27% at 18 months for participants receiving lecanemab compared to those receiving placebo. Additionally, the companies announced that all key secondary endpoints were met with highly statistically significant results.
Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL). For safety, the findings revealed that the profile of side effects such as brain swelling or microbleeds also known as amyloid-related imaging abnormalities (ARIA) incidence was within expectations. The total incidence of ARIA was 21.3% in the lecanemab group and 9.3% in the placebo group. Eisai announced plans to discuss this data with regulatory authorities with the aim to file for traditional approval in the US and to submit marketing authorisation applications in Japan and Europe by the end of March 2023. Alzheimer Europe welcomes the encouraging top-line results data reported today by Eisai and Biogen on the Clarity AD Phase III clinical trial of lecanemab and looks forward to hearing more at the upcoming Clinical Trials in Alzheimer’s Disease (CTAD) conference on 29 November (San Francisco, US). https://www.eisai.com/news/2022/news202271.html