Eisai to Present Four-Year Efficacy and Safety Data on Continuous Treatment with Lecanemab at The Alzheimer’s Association International Conference
Latest findings from Eisai's robust Alzheimer's disease (AD) pipeline include results from lecanemab long-term data, an immunoassay for measuring amyloid-β protofibrils in cerebrospinal fluid, and a subcutaneous form of lecanemab for continued treatment of AD
AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque deposition
NUTLEY, N.J., July 21, 2025 /PRNewswire/ -- Eisai Inc. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the company will present the latest findings from its robust Alzheimer's disease (AD) pipeline and research, including our dual-acting, anti-amyloid beta (Aβ) protofibril* antibody for the treatment of AD, lecanemab (generic name, U.S. brand name: LEQEMBI®), and anti-MTBR (microtubule binding region) tau antibody, etalanetug (E2814), at the Alzheimer's Association International Conference (AAIC), being held in Toronto and virtually from July 27 - 31. Eisai will present 21 oral presentations, 24 posters, three (3) symposia and two (2) lecanemab product theaters.
Key Oral Lecanemab Presentations
- 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
- 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.
Key Oral E2814 Presentation
- A Featured Research Session on Wednesday, July 30 (4:15 – 5:45 PM EDT) will include findings from the Anti-Tau Etalanetug (E2814) with Lecanemab Therapy in Individuals with Dominantly Inherited Alzheimer's Disease: A First Look at Baseline Characteristics and Impact of 6-Month Lecanemab Treatment on Amyloid PET and Safety in the DIAN-TU-001 NexGen Trial.
"The data presented at AAIC 2025 will highlight long-term findings from lecanemab's open-label extension trial, real-world lecanemab case studies as well as results on a subcutaneous formulation and dosing regimen that may offer patients more flexibility to continue treatment to fight Alzheimer's disease," said Lynn D. Kramer, M.D., FAAN, Chief Clinical Officer, Deep Human Biology Learning (DHBL), Eisai. "We will also share preliminary results from the DIAN-TU-001 NexGen Trial, exploring etalanetug with background lecanemab therapy to slow or prevent the progression of Alzheimer's disease. As we gain more experience using dual-acting lecanemab in different clinical settings and continue to explore new avenues to improve the diagnosis and treatment of Alzheimer's disease, we are hopeful about the future. We remain committed to patients and their loved ones who are impacted by this progressive, relentless disease, caused by a continuous underlying neurotoxic process that begins before and continues after plaque is removed from the brain."
Key Featured Research Sessions
Featured Research Session (FRS), #1-31-FRS-A: Anti-Amyloid Therapies in Clinical Practice: Real World Evidence and Implementation Consideration
4:15 - 5:45 PM EDT, Sunday, July 27
Session Program |
Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported Results (Abstract ID 103048) |
Featured Research Session, #4-13-FRS-C: Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's Disease
9:00 - 10:30 AM EDT, Wednesday, July 30
Session Program |
Development of Subcutaneous Lecanemab: Establishing the Comparability of Subcutaneous and Intravenous Lecanemab Formulations (Abstract ID 104694) |
Lecanemab Subcutaneous Formulation for Maintenance Dosing in Early Alzheimer's Disease (Abstract ID 104693) |
Clinical and Pharmacologic Profile of a Subcutaneous Lecanemab Formulation (Abstract ID 104691) |
Subcutaneous Lecanemab: Potential Benefits and Place in Therapy (Abstract ID 104695)
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Featured Research Session, #4-31-FRS-B: Anti-Tau Etalanetug (E2814) with Lecanemab Therapy in Individuals with Dominantly Inherited Alzheimer's Disease: A First Look at Baseline Characteristics and Impact of 6-Month Lecanemab Treatment on Amyloid PET and Safety in the DIAN-TU-001 NexGen Trial
4:15 - 5:45 PM EDT, Wednesday, July 30
Session Program |
DIAN-TU-001 Trial (Tau NexGen) Rationale and Enrollment Experience (Abstract ID 105298) |
Baseline Participant Clinical Characteristics in the DIAN-TU-001 Trial (Abstract ID 105299)
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Baseline Imaging Characteristics of Participants in the Phase II/III DIAN-TU- 001 Tau NexGen Trial for Dominantly Inherited Alzheimer's Disease (Abstract ID 105301) |
Lecanemab in DIAD: 6-Month Amyloid PET Results from the DIAN-TU-001 Trial (Abstract ID 105303) |
Safety of Lecanemab After 6-Month Treatment in the DIAN-TU-001 Trial (Abstract ID 105304) |
Key Developing Topics Sessions
Developing Topics On Real-World Data
8:00 - 8:45 AM EDT on Sunday, July 27
Session Program |
Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery in Early Alzheimer's Disease Patients (Abstract ID 108809) |
Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway Learnings from Diverse US Clinical Settings
9:00 - 10:30 AM EDT on Sunday, July 27
Session Program |
Real-World Use of Lecanemab in Patients with Early Alzheimer's Disease in the United States: A Case Series Review (Abstract ID 108599) |
Real-World Use of Lecanemab with Consideration of Race, Ethnicity and Geographical Diversity (Abstract ID 108602) |
Real-World Use of Lecanemab in APOE ε4 Homozygotes and in Patients on Antithrombotic Therapy (Abstract ID 108603) |
Physician Satisfaction with Lecanemab in Early Alzheimer's Disease: Real- World Insights from Prescribers in the United States (Abstract ID 108605) |
Real-World Insights on the Lecanemab Patient Pathway in Early Alzheimer's Disease in the United States (Abstract ID 108606) |
Blood-Based Biomarkers in the Lecanemab Patient Pathway for Early Alzheimer's Disease in the United States (Abstract ID 108607) |
Developing Topics On Innovative Therapeutic Approaches
8:00 - 8:45 AM EDT, Wednesday, July 30
Session Program |
The Lecanemab Clarity AD Open-Label Extension in Early Alzheimer's Disease: Initial Findings from the 48-Month Analysis (Abstract ID 108905) |
Additional Featured Research and Developing Topics Sessions
Biomarkers July 28 (Mon.) 9:00 – 10:30 AM EDT | Featured Research Session, #2-17-FRS-A: Sex Specific Risk And Protective Factors in Alzheimer's Disease Sex-Stratified GWAS Meta-Analyses Reveal Novel Sex-Specific Association with CSF Biomarkers of Alzheimer's Disease (Abstract ID 102560) |
Lecanemab July 29 (Tues.) 2:00 – 3:30 PM EDT | Developing Topics Session: Developing Topics On Tau Biomarkers Variations in Plasma p-Tau217 by Sociodemographic Factors Across World Regions in a Preclinical AD Clinical Trials Program: The AHEAD 3-45 Study (Abstract ID 108909) |
Clinical Trials July 30 (Weds.) 2:00 – 3:30 PM EDT | Featured Research Session, #4-26-FRS-A: Innovative Use of Statistical Models and Machine Learning to Enhance AD Clinical Trials Baseline Predictions of PACC Progression Trajectories in Preclinical AD Improve the Precision and Power of Treatment Effect Assessments (Abstract ID 99560) |
Poster Presentations
Asset/Project, and Time** | Title, Abstract Number |
Lecanemab July 27 (Sun.) | Results from a Human Factor Study Supporting Safe and Effective Use of the Lecanemab Subcutaneous Autoinjector (Abstract ID 106273) |
Lecanemab July 27 (Sun.) | Delphi Consensus for Implementation of Anti-Amyloid mAb Initiation in Private Practice Neurology: Preliminary Recommendations from Experienced Providers (Abstract ID 108789) |
Lecanemab July 28 (Mon.) | Target Engagement of Lecanemab on CSF Aβ Protofibril Toxic Species in Clarity AD (Abstract ID 108918) |
Lecanemab July 28 (Mon.) | Understanding Real-World Clinical Experience with Lecanemab: Capturing the Patient and Care Partner Voice Through Social Media Listening (Abstract ID 102018) |
Lecanemab July 29 (Tues.) | Patient and Care Partner Expectations and Emotional Experiences of Lecanemab: A Social Media Listening Study (Abstract ID 101001) |
Lecanemab July 29 (Tues.) | Lecanemab Real-World Use Perspectives from a New England Alzheimer's Disease Center: A Retrospective Chart Review (Abstract ID 101388) |
Lecanemab July 30 (Weds.) | Transitioning from Clinical Trial to Clinical Practice for Long-Term Lecanemab Treatment in Early Alzheimer's Disease: Perspectives from an Alzheimer's Disease Treatment Center (Abstract ID 101400) |
E2025 July 29 (Tues.) | Quantification of EphA4 Turnover Rate and Subsequent Validation of Target Engagement for E2025, a Novel Anti-EphA4 Antibody, in Human Neural Cells (Abstract ID 96834) |
E2814 July 30 (Weds.) | E2814 Mitigates Tau Pathology: Inhibiting Tau Uptake and Promoting MTBR- Tau Clearance Through Microglial Pathways in vitro (Abstract ID 102696) |
Biomarkers and Imaging July 27 (Sun.) | External Validation of Joint Propagation Model-Based Tau PET CenTauR Units (Abstract ID 106362) |
Biomarkers and Imaging July 28 (Mon.) | Identifying Differentially Expressed Proteins Between Amyloid Positive and Amyloid Negative Subjects Based on Alamar Multiplex Assay Data Using MissionAD Samples (Abstract ID 107031) |
Biomarkers and Imaging July 29 (Tues.) | Influence of Demographics and Scan Time on MK6240 Off-Target Signal and Reference Region Selection (Abstract ID 100424) |
Biomarkers July 27 (Sun.) | Observational Study Evaluating Blood-Based Biomarker Use for Confirmatory Alzheimer's Disease Diagnosis in Real-World Clinical Practice Within the United States (Abstract ID 99857) |
Biomarkers July 28 (Mon.) | A De Novo-Assisted Strategy to Identify Novel IncRNA-Encoded Peptides in Cerebrospinal Fluid of Demented Subjects With or Without Amyloid Positivity (Abstract ID 106893) |
Biomarkers July 28 (Mon.) | Impact of Blood-Based Biomarkers on Access to Alzheimer's Disease Treatments: A Simulation Study in Japan (Abstract ID 102553) |
Biomarkers July 29 (Tues.) | Implementation Science Study Evaluating the Real-World Use of Blood-Based Biomarkers as Confirmatory Diagnostic Tools for Alzheimer's Disease in the United States (Abstract ID 99804) |
Biomarkers July 29 (Tues.) | Characterization of Lewy Body Copathology in Early AD Clinical Trial Population Demonstrates Similarities and Differences Compared to Natural History Studies in Alzheimer's Disease Patients (Abstract ID 107102) |
Biomarkers July 30 (Weds.) | Value of Blood-Based Biomarker Testing to Diagnose, Identify and Monitor Patients with Alzheimer's Disease: A Structured Literature Review (Abstract ID 99842) |
Biomarkers July 30 (Weds.) | Alzheimer's Disease Molecular Subtypes in a Clinical Trial Cohort (Abstract ID 105257) |
General AD July 27 (Sun.) | Operational Consideration and Best Practices for Implementation of an Early Alzheimer's Disease Patient Care Pathway (Abstract ID 108093) |
General AD July 27 (Sun.) | Estimating Clinical Transitions in Patients with Alzheimer's Using Instrumental Activities of Daily Living (IADL) (Abstract ID 107058) |
General AD July 28 (Mon.) | Staging Alzheimer's Disease Using the Functional Assessment Screening Tool (FAST): A Crosswalk with the Montreal Cognitive Assessment (MoCA) (Abstract ID 107045) |
General AD July 29 (Tues.) | Time to Alzheimer's Disease Diagnosis in Japan: A Retrospective Observational Study (Abstract ID 97026) |
General AD July 30 (Weds.) | Alzheimer's Disease Staging by Instrumental Activities of Daily Living (IADL): A Crosswalk with the Montreal Cognitive Assessment (MoCA) (Abstract ID 107009) |
**Poster viewing time is set from 7:30 AM – 4:15 PM EDT on the date of presentation
Eisai-Sponsored Symposia
Asset/Project, and Time | Title |
General AD July 28 (Mon.) 6:00 – 7:30 PM EDT | Smoldering Alzheimer's Disease: The Ongoing Benefit of Addressing Multiple Pathologies |
General AD July 30 (Weds.) 6:15 – 7:45 AM EDT | Unlock Your Brain: Exploring Alzheimer's Disease from the Inside Out |
General AD July 30 (Weds.) 6:00 – 7:30 PM EDT | Brain Health Navigator—Ensuring Efficient and Effective Alzheimer's Disease Diagnostic and Clinical Care Pathways |
Eisai-Sponsored Product Theaters
Asset/Project, and Time | Title |
Lecanemab July 27 (Sun.) 12:25 – 1:05 PM EDT | Early Diagnosis, Early Treatment: Identifying Patients for Greater Benefit in Mild Cognitive Impairment Due to Alzheimer's Disease |
Lecanemab July 28 (Mon.) 12:25 – 1:05 PM EDT | Best Practices in Early Alzheimer's Disease Care: Creating a Plan from Screening Through Long-Term Treatment |
Product theaters will feature presentations based on real-world clinical experience with lecanemab - providing attendees with an opportunity to hear best practices and expert guidance on using this therapy.
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
* Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.2
MEDIA CONTACTS
Eisai Inc. (U.S.)
Julie Edelman
+1-862-213-5915
[email protected]
[Notes to editors]
- About lecanemab (LEQEMBI®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. 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 and being marketed in the U.S.,3 Japan,4 China,5 South Korea,6 Hong Kong,7 Israel,8 the United Arab Emirates,9 the United Kingdom,10 Mexico,11 Macau,12 Oman, Taiwan,13 European Union,14 Qatar, Singapore15 and Thailand16 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 the 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, Eisai and Biogen. 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 Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. - About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
References
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- Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
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SOURCE Eisai Inc.
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