Lecanemab long-term treatment data at AAIC 2024

BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced that its partner Eisai will present the latest findings on lecanemab (brand name Leqembi®) at the Alzheimer's Association International Conference (AAIC) 2024. This conference will take place in Philadelphia and virtually from July 28 to August 1, 2024. The presented data will cover three-year efficacy and safety information, as well as underscore the significance of ongoing treatment for Alzheimer's disease.

Eisai's presentations will highlight the critical importance of continuous treatment for Alzheimer's disease (AD). The key presentations will include three-year efficacy and safety data from Phase 2 and Phase 3 studies. They will also cover the mechanism of action of lecanemab in targeting toxic soluble aggregated amyloid-beta species (protofibrils) and the importance of maintenance treatment based on neurodegenerative biomarkers in plasma. Featured sessions will explore long-term imaging and fluid biomarkers and the evidence supporting the rationale for ongoing lecanemab dosing. Presenters like Dennis Selkoe, M.D., and Charlotte Teunissen, Ph.D., will provide insights into the sustained benefits of lecanemab treatment, emphasizing its potential to slow the progression of AD by clearing amyloid-beta protofibrils.

Additionally, BioArctic will present a poster on a study that highlights deficiencies in the healthcare system's ability to diagnose and treat Alzheimer's disease in the Nordic countries. Mats Ekelund, Head of Market Access at BioArctic, will display the poster.

Lecanemab is a product of the long-standing collaboration between BioArctic and Eisai. Originally developed by BioArctic, based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease, Eisai is responsible for its clinical development, market approval applications, and commercialization for Alzheimer's disease. BioArctic incurs no development costs for lecanemab in Alzheimer's disease and is entitled to payments tied to specific regulatory approvals, sales milestones, and a royalty of 9 percent on global sales. Moreover, BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and is currently preparing for joint commercialization in the area with Eisai.

Lecanemab is a result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, lecanemab's approvals were based on the large global Phase 3 Clarity AD study. In this study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the Clarity AD study results were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and published in the New England Journal of Medicine.

Eisai has also submitted applications for lecanemab's approval in 12 other countries and regions, including the European Union. A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was filed with the U.S. Food and Drug Administration (FDA) in March 2024. Additionally, a Biologics License Application (BLA) for a subcutaneous injection formulation, developed to improve patient convenience, was initiated in the U.S. under Fast Track status in May 2024.

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, who are clinically normal but have intermediate or elevated levels of amyloid in their brains, has been ongoing. This study is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium, 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), conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and led by Washington University School of Medicine in St. Louis, has been ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Since 2005, BioArctic has maintained a long-term collaboration with Eisai for the development and commercialization of drugs for treating Alzheimer's disease. Key agreements include the Development and Commercialization Agreement for the lecanemab antibody signed in 2007, and another agreement for the antibody Leqembi backup signed in 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. BioArctic retains the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization there with Eisai.