Lecanemab four-year efficacy and safety data to be presented at AAIC 2025

Rhea-AI Summary

BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai will present significant new data on Leqembi® (lecanemab) at the upcoming Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31, 2025.

Key presentations include four-year efficacy and safety data from the Phase 3 Clarity AD Open-Label Extension trial, new data on a subcutaneous formulation for maintenance dosing, and real-world case studies from U.S. clinical settings. Additionally, findings from cerebrospinal fluid samples using a novel immunoassay for measuring Aβ protofibrils will be presented.

Eisai leads the global development and regulatory submissions for Leqembi, with both Eisai and Biogen co-commercializing the product. BioArctic maintains commercialization rights in the Nordic region in partnership with Eisai.

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STOCKHOLM, July 22, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®), including four-year efficacy and safety data and data on the subcutaneous formulation for maintenance dosing, at the Alzheimer's Association International Conference (AAIC), being held in Toronto and virtually from July 27 - 31.

Key oral lecanemab presentations at AAIC

• Four-year data: On Wednesday, July 30, as part of the "Developing Topics Session: Innovative Therapeutic Approaches" (8:00 – 8:45 AM EDT), initial four-year findings will be presented on lecanemab from the Phase 3 Clarity AD Open-Label Extension in Early Alzheimer's Disease trial.
• Subcutaneous maintenance dosing: A Featured Research Session on Wednesday, July 30 (9:00 – 10:30 AM EDT) will include data on the potential of a new and convenient option for ongoing lecanemab treatment, the subcutaneous formulation for maintenance dosing.
• Real world case studies: A Developing Topics Session on Sunday, July 27 (9:00 – 10:30 AM EDT) will include data on real-world case studies and patient pathway learnings from diverse U.S. clinical settings two years post-approval of lecanemab.

Key Lecanemab Poster Presentation at AAIC

• A Poster Presentation on Monday, July 28 (viewing available from 7:30 AM – 4:15 PM EDT) will share findings on cerebrospinal fluid (CSF) samples collected from the Clarity AD trial and analyzed using the novel, sensitive immunoassay developed to measure Aβ protofibrils in CSF.

Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.

The information was released for public disclosure, through the agency of the contact person below, on July 22, 2025, at 8:00 a.m. CET.

For further information, please contact: 
Oskar Bosson, VP Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 704 107 180

About lecanemab (Leqembi^®)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). 

Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, the United Kingdom, Mexico, Macau, Oman, Taiwan, European Union, Qatar, Singapore and Thailand for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).  Eisai has submitted applications for approval of lecanemab in 11 countries and regions.

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and 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. 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. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap.

For further information, please visit www.bioarctic.com. 

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Lecanemab four-year efficacy and safety data to be presented at AAIC 2025

 

 

 

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SOURCE BioArctic

FAQ

When will the four-year Leqembi data be presented at AAIC 2025?

The four-year Leqembi data will be presented on Wednesday, July 30, 2025, from 8:00 - 8:45 AM EDT during the Developing Topics Session on Innovative Therapeutic Approaches.

What new Leqembi formulation will be discussed at AAIC 2025?

A subcutaneous formulation for maintenance dosing will be presented as a new and convenient option for ongoing Leqembi treatment during a Featured Research Session on July 30.

What real-world data will be presented for Leqembi at AAIC 2025?

Real-world case studies and patient pathway learnings from diverse U.S. clinical settings two years post-approval will be presented during a Developing Topics Session on Sunday, July 27.

What are BioArctic's commercial rights for Leqembi?

BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai, and the two companies are preparing for joint commercialization in the region.

What new research findings about Leqembi will be presented in the poster session?

The poster session on July 28 will present findings from cerebrospinal fluid samples from the Clarity AD trial, analyzed using a novel immunoassay to measure Aβ protofibrils in CSF.