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Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care
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Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice
CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau.
“At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer’s is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.”
Key Scientific Sessions and Presentations:
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Lecanemab Clarity AD OLE in Early AD: Initial Findings from 48-Month Analysis
Wednesday, July 30, 8:00–8:45 AM ET -
Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer’s Disease
Wednesday, July 30, 9:00–10:30 AM ET -
Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery
Sunday, July 27, 8:00–8:45 AM ET -
Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway Learnings
Sunday, July 27, 9:00–10:30 AM ET -
Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported Results
Sunday, July 27, 4:14–5:45 PM ET -
Innovations in Tau Therapies and Biomarkers for Alzheimer’s Disease: Bridging Research and Clinical Practice
Wednesday, July 30, 2:00–3:30 PM ET -
Baseline Characteristics from CELIA: A Phase 2 Study to Evaluate BIIB080 in Participants with Early Alzheimer’s Disease
Monday, July 28, 7:30 AM–4:15 PM ET
Educational Program on Tau in Alzheimer’s Disease
At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer’s disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on KnowTau.com, building on the resources already available.
For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth.
About BIIB080
BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer’s disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer’s disease.
In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis.
About LEQEMBI ® (lecanemab)
LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023.
LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.