EISAI TO PRESENT FULL FINDINGS FROM LECANEMAB CONFIRMATORY PHASE 3 CLINICAL TRIAL (CLARITY AD) AND OTHER ALZHEIMER’S DISEASE RESEARCH AT THE 15TH CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE
Eisai Co., Ltd. (Headquarters: Toyoko, CEO: Haruo Naito, “Eisai”) will present the efficacy, safety and biomarker findings from the company’s Phase 3 confirmatory Clarity AD clinical trial for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference. At the meeting, which will be held in San Francisco, CA and virtually from November 29 to December 2, Eisai and esteemed faculty will present the full data in a scientific session on the first day of the meeting (November 29 at 4:50 p.m. PT). Additionally, other important research from the lecanemab clinical development program and Eisai’s AD pipeline, including the company’s investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.
Topline results from Clarity AD were announced in late September and showed that lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was within expectations.
Key Eisai Lecanemab CTAD Presentations
- Clarity AD: Full results from the Phase 3 confirmatory Clarity AD clinical trial of lecanemab in patients with early AD will be presented in a scientific session on November 29 at 4:50 p.m. PT. Eisai will host a live webcast of presentations in the session and can be viewed live on the investors section of the Eisai Co., Ltd. website.
- Aβ Protofibrils Binding Properties: Research studying the characterization of Aβ protofibrils and the unique binding properties and mechanisms of Aβ clearance of lecanemab (Poster #P029)
- AHEAD 3-45 Study:
〇 An evaluation of tau PET screening data from the Phase 3 AHEAD 3-45 study of lecanemab for associations with plasma p-tau217 and cognitive testing (Late Breaker Oral #LB1)〇 A study exploring increased accuracy of amyloid PET prediction in preclinical AD using plasma levels for Abeta42/40 and p-tau217 ratios from the Phase 3 screening data from the AHEAD 3-45 study (Late Breaker Oral #LB2)
“Based on the Clarity AD results, the investigational anti-amyloid beta protofibril antibody lecanemab has the potential to make a clinically meaningful difference for people living with the early stages of Alzheimer’s disease and their families by slowing cognitive and functional decline,” said Lynn Kramer, M.D., Chief Clinical Officer, Alzheimer’s Disease and Brain Health at Eisai Co., Ltd. “Eisai is excited to share the results of the company’s confirmatory Phase 3 Clarity AD clinical study at CTAD and present important data exploring lecanemab’s potential efficacy, safety and use in a variety of early AD patient sub-populations.”
Eisai aims to file for traditional approval in the U.S. and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023. In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted it Priority Review. The Prescription Drug User Fee Act (PDUFA) action date is January 6, 2023. The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. In an effort to secure traditional FDA approval for lecanemab as soon as possible, Eisai submitted the BLA through the FDA’s Accelerated Approval Pathway so that the agency could complete its review of all lecanemab data with the exception of the data from the confirmatory Clarity AD study. In March 2022, Eisai began submitting application data, with the exception of Clarity AD data, to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system, with the aim of obtaining early approval for lecanemab so that people living with early AD may have access to the therapy as soon as possible.
CTAD 2022 Presentations Relating to Eisai’s Key Compounds, Research and Collaborations
| Scientific Session: Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab in Early Alzheimer’s Disease Tues, Nov 29, 4:50 – 6:05 p.m. PT |
|
|---|---|
| Chairman: Takeshi Iwatsubo, University of Tokyo | |
| Clarity AD: Clinical Trial Background and Study Design Overview |
Michael Irizarry Eisai Inc. |
| Lecanemab for the Treatment of Early Alzheimer’s Disease: Topline Efficacy Results from Clarity AD |
Christopher van Dyck Yale School of Medicine |
| Safety Profile of Lecanemab in Early Alzheimer’s Disease |
Marwan Sabbagh Barrow Neurological Institute |
| Imaging, Plasma and CSF Biomarkers Assessments from Clarity AD | Randall Bateman Washington University |
| Context of Clarity AD Results | Sharon Cohen Toronto Memory Program |
| Panel Discussion / Q&A | |
Oral Presentations
| Asset in Development, Session, Time (Pacific Time) | Presentation Title, Presenter/Authors |
|---|---|
|
Lecanemab |
Tau PET Associated with Plasma P-Tau217 and Cognitive Testing in Preclinical AD: Screening Data from the AHEAD Study A3 and A45 Trials Authors: K Johnson, et al |
|
Lecanemab Presentation Time: 10:45 – 11:00 a.m. |
Plasma Levels of Abeta42/40 and P-Tau217 Ratios Increase Accuracy of Amyloid PET Prediction in Preclinical AD Authors: R Rissman, et al |
|
E2814 |
CSF MTBR-tau243 is a Non-amyloid Specific Biomarker of Neurofibrillary Tangles of Alzheimer’s Disease Authors: K Horie, et al |
|
E2027 Presentation Time: 11:15 – 11:30 a.m. |
Results of a Phase 2/3 Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Study to Evaluate the Efficacy and Safety of 12 Week Treatment with the Phosphodiesterase 9 (PDE9) Inhibitor Irsenontrine (E2027) in Subjects with Dementia with Lewy Bodies Authors: M Irizarry, et al |
Poster Presentations
| Asset in Development, Session, Time (Pacific Time) | Presentation Title, Authors |
|---|---|
|
Lecanemab |
Development and Feasibility of a Data-Driven Approach to Preclinical Alzheimer’s Disease Clinical Trial Recruitment through Centralized Pre-Screening Data Collection Authors: D Kirn, et al |
|
Lecanemab Wed, Nov 30, 6:00 p.m. |
Characterization of Amyloid-Beta Protofibrils in Alzheimer’s Disease Brain and the Unique Binding Properties of Lecanemab Authors: L Lannfelt, et al |
|
E2027 Wed, Nov 30, 6:00 p.m. |
The Effects of the Novel Phosphodiesterase 9 (PDE9) Inhibitor E2027 (irsenontrine) on CSF cGMP, Additional CSF and Plasma Biomarkers, and Clinical Outcomes in Amyloid Positive and Amyloid Negative Patients with Dementia with Lewy Bodies and Parkinson’s Disease Dementia Authors: P Sachdev, et al |
|
General AD Wed, Nov 30, 6:00 p.m. |
Planning the Next Generation of Alzheimer’s Disease Clinical Trials Using Diverse Patient-Level Database from the Critical Path for Alzheimer’s Disease (CPAD) Consortium Authors: S Sivakumaran, et al |
|
General AD |
Critical Path for Alzheimer’s Disease (CPAD) Consortium: Accelerating and De-Risking Therapeutic Development in AD by Building Regulatory Decision-Making Tools |
|
General AD |
Baseline Plasma pTau181 Improves Prediction of Cognitive Decline in Amyloid Positive Subjects with Mild Cognitive Impairment |
|
General AD |
Identification of Medical Conditions as Risk Factors for Mild Cognitive Impairment: A US Claims Database Study |
|
General AD |
Prevalence Estimations for the Alzheimer’s Disease Continuum in the US Health and Retirement Study |
|
General AD |
Dementia Conversion Rate Differences Between Patients with High- and Low-Risk Amnestic Mild Cognitive Impairment in the Real-World: A Prospective, Multicenter, Observational Study |
Sysmex Poster Presentation
| Asset in Development, Session, Time (Pacific Time) | Presentation Title, Authors |
|---|---|
|
General AD Thu, Dec 1, 8:00 a.m. – 6:00 p.m. |
Three Group Classification of Participants Based on Fully Automated Plasma β-amyloid Measurements to Achieve High Positive and Negative Predictive Values Authors: K Yamashita, et al |
Eisai serves as the lead of lecanemab development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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.
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