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EISAI TO PRESENT DUAL-ACTING LECANEMAB THREE YEAR EFFICACY AND SAFETY DATA AND DISCUSS LONG-TERM OUTCOMES OF CONTINUED TREATMENT AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE 2024Latest findings from ÑÇÖÞ²ÊÆ±¹Ù꿉۪s robust Alzheimer’s disease (AD) pipeline will be shared, including the importance of continued treatment of AD, which is a progressive neurodegenerative disease that begins before plaque deposition and continues after plaque removal

ÑÇÖÞ²ÊÆ±¹ÙÍø. Ltd (Headquarters: Tokyo, CEO: Haruo Naito, “ÑÇÖÞ²ÊÆ±¹ÙÍø”) announced today that the company will present the latest findings on its 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®), at the Alzheimer’s Association International Conference (AAIC). Dual-acting lecanemab is the only early AD treatment available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain. The conference will be held in Philadelphia and virtually from July 28 to August 1, 2024. ÑÇÖÞ²ÊÆ±¹ÙÍø will present data and research in four (4) oral and 15 poster presentations at the meeting and will host two (2) sessions on lecanemab.

       

Perspectives Session: Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer's Disease?

  • On July 30 from 4:15 p.m. to 5:45 p.m. EDT, ÑÇÖÞ²ÊÆ±¹ÙÍø will present the latest data exploring three critical topics:
    1) Does the current evidence for lecanemab mechanism support a rationale for continued lecanemab dosing?
    2) Is the lecanemab maintenance dosing regimen supported by simulation models?
    3) Is there evidence for a continued benefit for long-term lecanemab treatment?
  • Dennis Selkoe, M.D., will focus on the toxicity of soluble aggregated amyloid-beta species, including oligomers, protofibrils and diffusible fibrils. The session will review the latest data on the mechanism of action of lecanemab, which binds to protofibrils and oligomers that continue to be produced even after plaques are cleared. Additional discussion will focus on the potential mechanistic justification for ongoing treatment to maintain clinical and biomarker efficacy.
  • Data from an intervening off-treatment period (gap period) occurring after the completion of the core phase of the Phase II Study 201 and before the initiation of the open-label extension (OLE) suggested the importance of continued administration of lecanemab. Youfang Cao, PhD., and Larisa Reyderman, Ph,D., from ÑÇÖÞ²ÊÆ±¹ÙÍø will present clinical pharmacology data and clinical pharmacology modeling outcomes that combine the outcomes from Study 201 and the Phase 3 Clarity AD study, which will provide insights into potential lecanemab maintenance dosing.
  • Christopher van Dyck, M.D., will present the latest 36-month efficacy and safety data from dual-acting lecanemab’s Phase 3 Clarity AD core and OLE studies and panelists will discuss the potential benefits of continuous treatment of AD, which is a progressive, neurodegenerative disease that begins before plaque deposition and continues after plaque removal.

Featured Research Session: Beyond Amyloid Removal with Lecanemab Treatment: Update on Long-Term Imaging and Fluid Biomarkers.

  • In this Featured Research session on July 30 from 2:00 PM to 3:30 PM EDT, the latest findings on imaging and fluid biomarkers from dual-acting lecanemab treatment will be presented.
  • Brian Willis, PhD., and Arnaud Charil, PhD of ÑÇÖÞ²ÊÆ±¹ÙÍø will present the outcomes of recent PK/PD modeling examining the potential connection between dual-acting lecanemab’s PK and amyloid PET, CDR-SB, and the outcomes of the tau PET from Carity AD core and OLE studies.
  • Nick Fox, M.D., FRCP, FMedSci, will explain the changes in brain volume that occur with anti-amyloid immunotherapy and its potential relationship to amyloid clearance.
  • Charlotte Teunissen, PhD., will present data on neurodegenerative biomarkers in plasma as a result of long-term treatment of dual-acting lecanemab, and will also explain the necessity for maintenance treatment from these changes in biomarkers.

“At AAIC 2024, ÑÇÖÞ²ÊÆ±¹ÙÍø will present the results from the Phase 2 and Phase 3 lecanemab studies and open label extensions exploring ongoing dosing with dual-acting lecanemab for potential longer-term clinical and biomarker benefit,” said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research at ÑÇÖÞ²ÊÆ±¹ÙÍø Inc. “Alzheimer’s disease (AD) is a progressive and relentless disease caused by a continuous underlying neurotoxic process. There is an urgency to treat because early and ongoing treatment can slow the progression of Alzheimer’s disease. The earlier mild cognitive impairment (MCI) due to AD and mild AD dementia are diagnosed and treated, the greater the opportunity for the patient to benefit.”

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Key Presentation

â– Perspectives Session:

Does the Current Evidence Base Support Lecanemab Continued Dosing for Early Alzheimer’s Disease?

From 4:15 PM to 5:45 PM EDT on July 30, 2024

     

Session Program

Does the Current Evidence for Lecanemab Mechanism Support a Rationale for Continued Lecanemab Dosing?

How Does the Latest Clinical Pharmacology Data & Modeling Support Continued Lecanemab Dosing?

Neuro-Dynamic Quantitative Systems Pharmacology (QSP) Model Supports Continued Lecanemab Treatment With Maintenance Dosing For Alzheimer’s Disease

Is there Evidence for a Continued Benefit for Long-Term Lecanemab Treatment?
A Benefit/Risk Update from Long-Term Efficacy, Safety and Biomarker Data

Q&A

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â– &²Ô²ú²õ±è;Featured Research Session

Beyond Amyloid Removal with Lecanemab Treatment: Update on Long-Term Imaging and Fluid Biomarkers〶Ä
From 2:00 PM to 3:30 PM EDT on July 30, 2024

     

Session Program

Amyloid Plaque Reduction as a Biomarker of Efficacy: Assessment of Amyloid PET and Change in CDR-SB Utilizing Semi-Mechanistic Model

Lecanemab Slows Tau PET Accumulation

“Paradoxical” Cerebral Volume Changes in Anti-Amyloid Immunotherapy Trials

Long-Term Effects of Lecanemab on Biomarkers of Neurodegeneration in Plasma

Q&A

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â–  Oral Presentations

Asset/Project, Presentation
Date and Time (EDT, U.S)
Topic, Abstract number

Lecanemab
July 30 (Tue) 2:42 PM – 2:49 PM

Examining Lecanemab-Associated Amyloid-Beta Protofibril as a Proximal Biomarker of Neurodegeneration Unlike Other Plaque-Associated Biomarkers
Abstract ID #94585

Lecanemab
July 30 (Tue) 2:49 PM – 2:56 PM

Lecanemab, Amyloid-Induced Tau Pathology as Supported CSF MTBR-tau243 in Clarity AD
Abstract ID #95507

E2027
July 31 (Wed) 5:05 PM – 5:15 PM

The Effects of the Novel Phosphodiesterase 9 (pde9) Inhibitor E2027 (irsenontrine) on CSF Proteomics Profile in Amyloid Positive and Amyloid Negative Lewy Body Dementia
Abstract ID #91293

General AD

July 29 (Mon) 8:00 AM - 8:10 AM
Unmet Needs in the Diagnosis and Management of Early AD in Community-Based Settings in the United States
Abstract ID #89135

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â–  Poster Presentations

Asset/Project, Presentation
Date and Time (EDT, U.S)
Topic, Abstract number

Lecanemab

July 28 (Sun)
Model-Based Assessment of Lecanemab Maintenance Dosing Regimen and Potential for Continued Suppression of Amyloid Plaque, Disease Progression
Abstract ID #89308

E2814

July 30 (Tue)
Crystal Structure of E2814 Bound to Tau
Abstract ID #94773

E2511

July 28 (Sun)
Non-Clinical Evidence for Modulating Synaptic CSF Biomarkers by E2511: A Novel Small Compound TrkA Biased Positive Allosteric Modulator
Abstract ID #95071

E2025

July 28 (Sun)
E2025, A Novel Anti-EphA4 Antibody, Enhances EphA4 Cleavage, and Suppresses Tau Pathologies in a Transgenic Model of AD
Abstract ID #94810

Biomarker

July 29 (Mon)
Prediction of Regional Brain Tau Levels in Early Alzheimer's Disease Using Plasma pTau217
Abstract ID #95793

Biomarker

July 31 (Wed)

A Prospective Multi-Clinic Implementation Science Study to Evaluate Use of Blood- Based Biomarkers as Confirmatory Diagnostic Tools for Early Alzheimer's Disease in Real-World Clinical Practice

Abstract ID #88784

Biomarkers

July 30 (Tue)
Advancing Early Detection of Alzheimer's Disease in the Primary Care Setting in the United States
Abstract ID #86582

Imaging

July 31 (Wed)
Volumes of Specific Substrates Within the Amygdala and Hippocampus are Impacted by Brain Amyloid-β
Abstract ID #92024

General AD

July 28 (Sun)
Total Healthcare Costs Across the Alzheimer’s Disease Continuum in the United States (US)
Abstract ID #86386

General AD

July 29 (Mon)
Risk Factors for Mild Cognitive Impairment: Prediction Models Developed with Electronic Health Record Data
Abstract ID #85564

General