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
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 at4:50 p.m. PT .Eisai will host a live webcast of presentations in the session and can be viewed live on the investors section of theEisai 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:
- 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)
- 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
CTAD 2022 Presentations Relating to
Scientific Session:
Clarity AD:
A Phase 3 Placebo-Controlled, Double-Blind,
Tues, |
|
Chairman: |
|
Clarity AD: Clinical Trial Background and Study Design Overview |
|
Lecanemab for the Treatment of Early Alzheimer's Disease: Topline Efficacy Results from Clarity AD |
|
Safety Profile of Lecanemab in Early Alzheimer's Disease |
|
Imaging, Plasma and CSF Biomarkers Assessments from Clarity AD |
|
Context of Clarity AD Results |
Toronto Memory Program |
Panel Discussion / Q&A |
Oral Presentations
Asset in Development, Session, Time (Pacific Time) |
Presentation Title, Presenter/Authors |
Lecanemab
Session:
Late Breaking Oral
|
Tau PET Associated with Plasma P-Tau217 and Cognitive
Presenter: K Johnson |
Lecanemab
Session:
Late Breaking Oral
|
Plasma Levels of Abeta42/40 and P-Tau217 Ratios Increase
Presenter: R Rissman |
E2814
Session:
Session Time: 3:00 –
Presentation Time: 3:15 p.m
. – |
CSF MTBR-tau243 is a Non-amyloid Specific Biomarker of
Presenter: K Horie |
E2027
Session:
#OC2
|
Results of a Phase 2/3 Placebo-Controlled, Double-Blind,
Phosphodiesterase 9 (PDE9) Inhibitor Irsenontrine (E2027) in
Presenter: M Irizarry |
Poster Presentations
Asset in Development, Session, |
Presentation Title, Authors |
Lecanemab Session: Clinical Trials Methodology: #P012
Tues,
|
Development and Feasibility of a Data-Driven Approach to
Authors: |
Lecanemab Session: New Therapies and Clinical Trials: #P029
Tues,
|
Characterization of Amyloid-Beta Protofibrils in Alzheimer's
Authors: |
E2027 Session: Clinical Trials Results: #P048
Tues,
|
The Effects of the Novel Phosphodiesterase 9 (PDE9) Inhibitor
Authors: |
General AD Session: Clinical Trials Results: #P037
Tues,
|
Planning the Next Generation of Alzheimer's Disease Clinical Authors: S Sivakumaran, et al |
General AD Session: Clinical Trials Results: #P038
Tues,
|
Critical Path for Authors: S Sivakumaran, et al |
General AD Session: Clinical Trials Biomarkers Including Plasma: #LP66
|
Baseline Plasma pTau181 Improves Prediction of Cognitive
Authors: |
General AD Session: Epidemiology and Clinical Trials: #P176
|
Identification of Medical Conditions as Risk Factors for Mild
Authors: |
General AD Session: Epidemiology and Clinical Trials: #P184
|
Prevalence Estimations for the Alzheimer's Disease Continuum
Authors: A |
General AD Session: Cognitive and Functional Endpoints: #P139 (Virtual Only)
|
Dementia Conversion Rate Differences Between Patients with
Authors: |
Sysmex Poster Presentation
Asset in Development, Session, |
Presentation Title, Authors |
General AD Session: Clinical Trials Biomarkers Including Plasma: #LP84A
|
Three Group Classification of Participants Based on Fully
Authors: |
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.
Media Inquiries:
+81-(0)3-3817-5120
+1-201-753-1945
Libby_Holman@eisai.com
(
EMEA-comms@eisai.net
[Notes to editors]
1. About Clarity AD
Study title |
A Study to Confirm Safety and Efficacy of Lecanemab in Participants with Early |
Study population |
1,795 participants of mild cognitive impairment (MCI) due to AD and mild AD |
Treatment administered |
10 mg/kg bi-weekly of lecanemab |
Duration of treatment |
18 months |
Study locations |
|
Primary endpoint |
Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB
*
) |
Key secondary endpoints |
Change From Baseline in Amyloid Positron Emission Tomography (PET) using |
* CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.
** ADAS-cog is the most common cognitive assessment instrument used in AD clinical trials all over the world. ADAS-cog14 consists of 14 competencies: word recall, commands, constructional praxis, object and finger naming, ideational praxis, orientation, word recognition, remembering word recognition instructions, comprehension of spoken language, word finding difficulty, spoken language ability, delayed word recall, number cancellation and maze task. ADAS-cog has been used in clinical trials for earlier stages of AD including MCI.
*** Developed by
**** ADCS MCI-ADL assesses the competence of patients with MCI in activities of daily living (ADLs), based on 24 questions to the patient's partner about actual recent activities of daily living.
2.
About Lecanemab (Development code: BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for AD that is the result of a strategic research alliance between
In the global Phase 3 confirmatory Clarity AD study, lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat (ITT) population. Starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo (all p-values are less than 0.01). All key secondary endpoints were also met with highly statistically significant results compared with placebo (p<0.01). Key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL). The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group and 1.7% in the placebo group. The incidence of symptomatic ARIA-E was 2.8% in the lecanemab group and 0.0% in the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) rate was 17.0% in the lecanemab group and 8.7% in the placebo group. The incidence of symptomatic ARIA-H was 0.7% in the lecanemab group and 0.2% in the placebo group. There was no imbalance in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) between lecanemab (8.8%) and placebo (7.6%). The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group. Overall, lecanemab's ARIA incidence profile was within expectations.
Since
Since
Furthermore,
3.
About E2814
An investigational anti-microtubule binding region (MTBR) tau antibody, E2814, is being developed as a disease-modifying agent for tauopathies including sporadic AD. Phase I clinical studies are underway. E2814 was discovered as part of the research collaboration between
4.
About the Collaboration between
5.
About the Collaboration between
Since 2005,
6.
About the Collaboration between
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