BioArctic AB's (publ) partner Eisai announced that Leqembi®? has been approved for treatment of Alzheimer's disease (AD) in Israel. Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mildementia stage of disease, the population in which treatment was initiated in clinical trials.

Israel is the sixth territory to approve Leqembi following the US, Japan, China, South Korea and Hong Kong. Leqembi's approval in Israel is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results.

Leqembi selectively binds to soluble amyloid-beta (Ab) aggregates (protofibrils), as well as insoluble Ab aggregates (fibrils) which are a major component of Ab plaques in AD, thereby reducing both Ab protofibrils and Ab plaques in the brain. Leqembi is the world's first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqem bi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease.

Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. Lecanemab (generic name, brand name: Leqembi®?) is the result of a strategic research alliance between BioArctic and E is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Ab). Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel.

Lecanemab approvals were based on the large global Phase3 Clarity AD study. In The Clarity AD study, lecanemab met its primary endpoint and all Key secondary endpoints with statistically significant Results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai has also submitted applications for approval of lecanemab in 12 countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status in May 2024.

Since July 2020Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St.