Results show reduction of clinical decline in global study of people with Alzheimer's Disease
Eisai has announced positive top-line results from its global phase 3 confirmatory Clarity AD clinical trial of lecanemab – an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD).
Clarity AD was a global confirmatory phase 3 placebo-controlled, double-blind, parallel-group, randomised study in 1,795 people with early AD. Furthermore, Eisai's recruitment strategy for the trial ensured greater inclusion of ethnic and racial populations, resulting in approximately 25% of the total enrolment including Hispanic and African American people living with early AD.
Lecanemab met the primary endpoint and all key secondary endpoints with statistically significant results. During the trial, the therapy also reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo after 18 months by 27%.
The company will discuss the data with regulatory authorities in the US, Japan and Europe, with a view to filing for traditional approval in the US as well as marketing authorisation applications in Japan and Europe by 2023.
Additionally, Eisai will present the Clarity AD study results at the Clinical Trials on Alzheimer's Congress (CTAD) in November and publish the findings in a peer-reviewed medical journal.
"Alzheimer's disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole," reflected Haruo Naito, chief executive officer at Eisai.
"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. The successful results of the Clarity AD clinical trial would not be possible without the truly inspiring dedication of the study's participants, their families and caregivers and the clinical investigators around the world. We thank all the people involved in the study for their invaluable contributions," he added.