EISAI TO PRESENT FOUR-YEAR EFFICACY AND SAFETY DATA ON CONTINUOUS TREATMENT WITH LECANEMAB AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2025
Latest findings from Eisai's robust Alzheimer's disease (AD) pipeline include results from lecanemab long-term data, an immunoassay for measuring amyloid- 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 (A ) 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 A 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)
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)
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 4 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 Featured Research Session, #2-17-FRS-A: Sex Specific Risk
And Protective
Factors in Alzheimer's Disease
July 28 (Mon.)
9:00 - 10:30 AM EDT Sex-Stratified GWAS Meta-Analyses Reveal Novel Sex-
Specific Association
with CSF Biomarkers of Alzheimer's Disease (Abstract ID
102560)
Lecanemab Developing Topics Session: Developing Topics On Tau
Biomarkers
July 29 (Tues.) Variations in Plasma p-Tau217 by Sociodemographic Factors
Across World
2:00 - 3:30 PM EDT Regions in a Preclinical AD Clinical Trials Program: The
AHEAD 3-45 Study
(Abstract ID 108909)
Clinical Trials Featured Research Session, #4-26-FRS-A: Innovative Use of
Statistical
Models and Machine Learning to Enhance AD Clinical Trials
July 30 (Weds.)
2:00 - 3:30 PM EDT 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,
Title, Abstract Number
Presentation Date
and Time**
Lecanemab Results from a Human Factor Study Supporting Safe and Effective
Use of the
Lecanemab Subcutaneous Autoinjector (Abstract ID 106273)
July 27 (Sun.)
Lecanemab Delphi Consensus for Implementation of Anti-Amyloid mAb
Initiation in Private
Practice Neurology: Preliminary Recommendations from
Experienced
July 27 (Sun.)
Providers (Abstract ID 108789)
Lecanemab Target Engagement of Lecanemab on CSF A Protofibril Toxic
Species in
Clarity AD (Abstract ID 108918)
July 28 (Mon.)
Lecanemab Understanding Real-World Clinical Experience with Lecanemab:
Capturing the
Patient and Care Partner Voice Through Social Media Listening
(Abstract ID
July 28 (Mon.)
102018)
Lecanemab Patient and Care Partner Expectations and Emotional Experiences
of
Lecanemab: A Social Media Listening Study (Abstract ID 101001)
July 29 (Tues.)
Lecanemab Lecanemab Real-World Use Perspectives from a New England
Alzheimer's
Disease Center: A Retrospective Chart Review (Abstract ID
101388)
July 29 (Tues.)
Lecanemab Transitioning from Clinical Trial to Clinical Practice for
Long-Term Lecanemab
Treatment in Early Alzheimer's Disease: Perspectives from an
Alzheimer's
July 30 (Weds.)
Disease Treatment Center (Abstract ID 101400)
E2025 Quantification of EphA4 Turnover Rate and Subsequent Validation
of Target
Engagement for E2025, a Novel Anti-EphA4 Antibody, in Human
Neural Cells
July 29 (Tues.)
(Abstract ID 96834)
E2814 E2814 Mitigates Tau Pathology: Inhibiting Tau Uptake and
Promoting MTBR-
Tau Clearance Through Microglial Pathways in vitro (Abstract ID
102696)
July 30 (Weds.)
Biomarkers and Imaging External Validation of Joint Propagation Model-Based Tau PET
CenTauR Units
(Abstract ID 106362)
July 27 (Sun.)
Biomarkers and Imaging Identifying Differentially Expressed Proteins Between Amyloid
Positive and
Amyloid Negative Subjects Based on Alamar Multiplex Assay Data
Using
July 28 (Mon.)
MissionAD Samples (Abstract ID 107031)
Biomarkers and Imaging Influence of Demographics and Scan Time on MK6240 Off-Target
Signal and
Reference Region Selection (Abstract ID 100424)
July 29 (Tues.)
Biomarkers Observational Study Evaluating Blood-Based Biomarker Use for
Confirmatory
Alzheimer's Disease Diagnosis in Real-World Clinical Practice
Within the
July 27 (Sun.)
United States (Abstract ID 99857)
Biomarkers A De Novo-Assisted Strategy to Identify Novel IncRNA-Encoded
Peptides in
Cerebrospinal Fluid of Demented Subjects With or Without
Amyloid Positivity
July 28 (Mon.)
(Abstract ID 106893)
Biomarkers Impact of Blood-Based Biomarkers on Access to Alzheimer's
Disease
Treatments: A Simulation Study in Japan (Abstract ID 102553)
July 28 (Mon.)
Biomarkers Implementation Science Study Evaluating the Real-World Use of
Blood-Based
Biomarkers as Confirmatory Diagnostic Tools for Alzheimer's
Disease in the
July 29 (Tues.)
United States (Abstract ID 99804)
Biomarkers Characterization of Lewy Body Copathology in Early AD Clinical
Trial
Population Demonstrates Similarities and Differences Compared
to Natural
July 29 (Tues.) History Studies in Alzheimer's Disease Patients (Abstract ID
107102)
Biomarkers Value of Blood-Based Biomarker Testing to Diagnose, Identify
and Monitor
Patients with Alzheimer's Disease: A Structured Literature
Review (Abstract ID
July 30 (Weds.)
99842)
Biomarkers Alzheimer's Disease Molecular Subtypes in a Clinical Trial
Cohort (Abstract ID
105257)
July 30 (Weds.)
General AD Operational Consideration and Best Practices for Implementation
of an Early
Alzheimer's Disease Patient Care Pathway (Abstract ID 108093)
July 27 (Sun.)
General AD Estimating Clinical Transitions in Patients with Alzheimer's
Using Instrumental
Activities of Daily Living (IADL) (Abstract ID 107058)
July 27 (Sun.)
General AD Staging Alzheimer's Disease Using the Functional Assessment
Screening Tool
(FAST): A Crosswalk with the Montreal Cognitive Assessment
(MoCA)
July 28 (Mon.)
(Abstract ID 107045)
General AD Time to Alzheimer's Disease Diagnosis in Japan: A Retrospective
Observational Study (Abstract ID 97026)
July 29 (Tues.)
General AD Alzheimer's Disease Staging by Instrumental Activities of Daily
Living (IADL):
A Crosswalk with the Montreal Cognitive Assessment (MoCA)
(Abstract ID
July 30 (Weds.)
107009)
**Poster viewing time is set from 7:30 AM - 4:15 PM EDT on the date of presentation
Eisai-Sponsored Symposia
Asset/Project,
Title
Presentation
Date
and Time
General AD Smoldering Alzheimer's Disease: The Ongoing Benefit of
Addressing Multiple
Pathologies
July 28 (Mon.)
6:00 - 7:30 PM
EDT
General AD Unlock Your Brain: Exploring Alzheimer's Disease from the
Inside Out
July 30 (Weds.)
6:15 - 7:45 AM
EDT
General AD Brain Health Navigator-Ensuring Efficient and Effective
Alzheimer's Disease
Diagnostic and Clinical Care Pathways
July 30 (Weds.)
6:00 - 7:30 PM
EDT
Eisai-Sponsored Product Theaters
Asset/Project,
Title
Presentation
Date
and Time
Lecanemab Early Diagnosis, Early Treatment: Identifying Patients for
Greater Benefit in
Mild Cognitive Impairment Due to Alzheimer's Disease
July 27 (Sun.)
12:25 - 1:05 PM
EDT
Lecanemab Best Practices in Early Alzheimer's Disease Care: Creating a
Plan from
Screening Through Long-Term Treatment
July 28 (Mon.)
12:25 - 1:05 PM
EDT
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 A , 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 A 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
Julie_Edelman@Eisai.com
[Notes to editors]
1. 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 (A
). 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, Singapore(15) and Thailand(16) 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.
2. About the Collaboration between Eisai and Biogen for ADEisai 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.
3. About the Collaboration between Eisai and BioArctic for ADSince 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
1. Amin L, Harris DA. A receptors specifically recognize molecular features
displayed by fibril ends and neurotoxic oligomers. Nat Commun.
2021;12:3451. doi: 10.1038/s41467-021-23507-z.
2. Ono K, Tsuji M. Protofibrils of Amyloid- 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.
3. U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer's
Disease Treatment to Traditional Approval. Last accessed: July 2025.
4. Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and
Biogen. Last accessed: July 2025.
5. The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in
China. Last accessed: July 2025.
6. Pharmaceutical Technology. 2024. South Korea's MFDS approves
Eisai-Biogen's LEQEMBI for Alzheimer's. Last accessed: July 2025.
7. Pharmaceutical Technology. 2024. Hong Kong approves Leqembi for
Alzheimer's treatment. Last accessed: July 2025.
8. Israel Ministry of Health. The Israeli Drug Registry. Leqembi. Last
accessed: July 2025.
9. United Arab Emirates Ministry of Health & Prevention. 2024. Registered
Medical Product Directory. Leqembi. Last accessed: July 2025.
10. BioSpace. 2024. Leqembi authorized for early Alzheimer's disease in
Great Britain. Last accessed: July 2025.
11. COFEPRIS authorizes innovative treatment for Alzheimer's patients.
Available at: https://bit.ly/3OKks6Y. Last accessed: July 2025.
12. Macau Special Administrative Region Drug Search. ssm.gov.mo/dafweb/.
Last accessed: July 2025.
13. Taiwan Food and Drug Administration Assessment Report.
http://bit.ly/454Oawe. Last accessed: July 2025.
14. European Medicines Agency. Leqembi | European Medicines Agency (EMA).
Last accessed: July 2025.
15. Health Sciences Authority.
https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approval
s---may-2025. Last accessed: July 2025.
16. Thailand Food and Drug Administration, Ministry of Public Health.
pertento.fda.moph.go.th/FDA_INFORMATION_DRUG/Home/Phar_Product_Inform_Pa
ge?Newcode=U1DR1C1072680001311C. Last accessed: July 2025.
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