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 lecanemab CTAD presentations
- Clarity AD: 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 and lecanemab ninding properties: Research studying the characterization of Aβ protofibrils and the unique binding properties and mechanisms of Aβ clearance of lecanemab (Poster #P029)
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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 Aβ42/40 and p-tau217 ratios from screening data from the Phase 3 study AHEAD 3-45 (Late Breaker Oral #LB2)
CTAD 2022 presentations relating to lecanemab
Scientific Session:
Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, | |
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 | Sharon CohenToronto Memory Program |
Panel Discussion / Q&A |
Oral presentations
Asset in Development, Session, Time (Pacific Time) | Presentation Title, Presenter/Authors |
LecanemabSession: Session Time: Presentation Time: |
Tau PET Associated with Plasma P-Tau217 and Cognitive Testing in Preclinical AD: Screening Data from the AHEAD Study A3 and A45 TrialsPresenter: K Johnson Authors: |
LecanemabSession: Session Time: Presentation Time: |
Plasma Levels of Abeta42/40 and P-Tau217 Ratios Increase Accuracy of Amyloid PET Prediction in Preclinical ADPresenter: R Rissman Authors: |
Poster presentations
Asset in Development, Session, Time (Pacific Time) | Presentation Title, Authors |
LecanemabSession: Clinical Trials Methodology: #P012Tues, | Development and Feasibility of a Data-Driven Approach to Preclinical Alzheimer's Disease Clinical Trial Recruitment through Centralized Pre-Screening Data CollectionAuthors: D Kirn, et al |
LecanemabSession: New Therapies and Clinical Trials: #P029Tues, |
Characterization of Amyloid-Beta Protofibrils in Alzheimer's Disease Brain and the |
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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.
The information was released for public disclosure, through the agency of the contact persons below, on
For further information, please contact:
E-mail: gunilla.osswald@bioarctic.se
Phone: +46 8 695 69 30
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About Clarity AD
Study title | A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD) |
Study population | 1,795 participants 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 in the global study, and an additional 111 subjects ongoing in China. |
Treatment administered | 10 mg/kg bi-weekly of lecanemab or placebo |
Duration of treatment | 18 months |
Study locations | Japan, the U.S., Europe and China |
Primary endpoint | Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB)[2] at 18 months |
Key secondary endpoints |
Change From Baseline at 18 months in: Amyloid Positron Emission Tomography (PET) using Centiloids Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14[3]) Alzheimer's Disease Composite Score (ADCOMS[4]) Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL[5]) |
About lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between BioArctic and Eisai. Lecanemab selectively binds to neutralize and eliminate soluble toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only late-stage anti-Aβ antibody that can be used for the treatment of early AD without the need for titration, enabling full treatment effect from day one.
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.
The Clarity AD open-label extension is underway with treatment initiated after completion of the Core period to further evaluate the safety and efficacy of lecanemab. In addition, the lecanemab Phase 3 clinical study AHEAD 3-45 is ongoing for individuals with preclinical (asymptomatic) AD, meaning they are clinically normal and have intermediate or elevated levels of brain amyloid. AHEAD 3-45 is conducted as a public-private partnership between the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed in
About
[1] Lecanemab is 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.
[2] 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 a 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 early stages of AD.
[3] ADAS-cog is the most common cognitive assessment instrument used in Alzheimer's disease 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 trials for earlier stages of AD including MCI.
[4] Developed by Eisai, combines items from the ADAS-cog scale for assessing cognitive functions, MMSE and the CDR scale for evaluating the severity of dementia to enable highly sensitive detection of changes in clinical functions of early AD symptoms and changes in memory
[5] 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.
https://news.cision.com/bioarctic/r/results-from-lecanemab-confirmatory-phase-3-clarity-ad-study-to-be-presented-at-15th-clinical-trials,c3669857
https://mb.cision.com/Main/9978/3669857/1682717.pdf
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