\u3007 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)<\/span><\/div>\n

\u3007 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)<\/span><\/div>\n<\/li>\n<\/ul>\n

\u201cBased 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\u2019s disease and their families by slowing cognitive and functional decline,\u201d said Lynn Kramer, M.D., Chief Clinical Officer, Alzheimer\u2019s Disease and Brain Health at Eisai Co., Ltd. \u201cEisai is excited to share the results of the company\u2019s confirmatory Phase 3 Clarity AD clinical study at CTAD and present important data exploring lecanemab\u2019s potential efficacy, safety and use in a variety of early AD patient sub-populations.\u201d<\/div>\n

<\/p>\n

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\u2019s FY2022, which ends March 31, 2023. In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai\u2019s 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\u2019s 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\u2019s 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.<\/p>\n

<\/p>\n

CTAD 2022 Presentations Relating to Eisai’s Key Compounds, Research and Collaborations
\n<\/b><\/p>\n

\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n

Scientific Session: Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab in Early Alzheimer’s Disease<\/strong>
\n<\/b>Tues, Nov 29, 4:50 \u2013 6:05 p.m. PT<\/th>\n<\/tr>\n
Chairman: Takeshi Iwatsubo, University of Tokyo<\/td>\n<\/tr>\n
Clarity AD: Clinical Trial Background and Study Design Overview<\/td>\n \n
Michael Irizarry<\/p>\n
Eisai Inc.<\/p>\n<\/td>\n<\/tr>\n
Lecanemab for the Treatment of Early Alzheimer\u2019s Disease: Topline Efficacy Results from Clarity AD<\/td>\n \n
Christopher van Dyck<\/p>\n
Yale School of Medicine<\/p>\n<\/td>\n<\/tr>\n
Safety Profile of Lecanemab in Early Alzheimer\u2019s Disease<\/td>\n \n
Marwan Sabbagh<\/p>\n
Barrow Neurological Institute<\/p>\n<\/td>\n<\/tr>\n
Imaging, Plasma and CSF Biomarkers Assessments from Clarity AD<\/td>\n Randall Bateman
\nWashington University<\/td>\n<\/tr>\n
Context of Clarity AD Results<\/td>\n Sharon Cohen
\nToronto Memory Program<\/td>\n<\/tr>\n
Panel Discussion \/ Q&A<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/h2>\n
Oral Presentations<\/b><\/p>\n
\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n

Asset in Development, Session, Time (Pacific Time)<\/b><\/th>\n Presentation Title, Presenter\/Authors<\/b><\/th>\n<\/tr>\n
\n
Lecanemab
\n<\/b>Session: Late Breaking Oral Communications: #LB1
\nWed, Nov 30
\nSession Time: 10:30 \u2013 11:00 a.m.
\nPresentation Time: 10:30 \u2013 10:45 a.m.<\/p>\n<\/td>\n
\n
Tau PET Associated with Plasma P-Tau217 and Cognitive Testing in Preclinical AD: Screening Data from the AHEAD Study A3 and A45 Trials
\nPresenter: K Johnson<\/p>\n
Authors: K Johnson, et al<\/p>\n<\/td>\n<\/tr>\n
\n
Lecanemab
\n<\/b>Session: Late Breaking Oral Communications: #LB2
\nWed, Nov 30
\nSession Time: 10:30 \u2013 11:00 a.m.<\/p>\n
Presentation Time: 10:45 \u2013 11:00 a.m.<\/p>\n<\/td>\n
\n
Plasma Levels of Abeta42\/40 and P-Tau217 Ratios Increase Accuracy of Amyloid PET Prediction in Preclinical AD
\nPresenter: R Rissman<\/p>\n
Authors: R Rissman, et al<\/p>\n<\/td>\n<\/tr>\n
\n
E2814
\n<\/b>Session: Late Breaking Oral Communications: #LB4
\nWed, Nov 30
\nSession Time: 3:00 \u2013 3:45 p.m.
\nPresentation Time: <\/b>3:15 p.m. \u2013 3:30 p.m.<\/p>\n<\/td>\n
\n
CSF MTBR-tau243 is a Non-amyloid Specific Biomarker of Neurofibrillary Tangles of Alzheimer\u2019s Disease
\nPresenter: K Horie<\/p>\n
Authors: K Horie, et al<\/p>\n<\/td>\n<\/tr>\n
\n
E2027
\n<\/b>Session: Oral Communications:
\n#OC2
\nWed, Nov 30
\nSession Time: 11:00 a.m. \u2013 12:15 p.m.<\/p>\n
Presentation Time: 11:15 \u2013 11:30 a.m.<\/p>\n<\/td>\n
\n
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
\nPresenter: M Irizarry<\/p>\n
Authors: M Irizarry, et al<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/p>\n
Poster Presentations<\/b><\/p>\n
\n\n\n\n<\/colgroup>\n\n\n\n\n\n\n\n\n\n\n\n

Asset in Development, Session, Time (Pacific Time)<\/b><\/th>\n Presentation Title, Authors<\/b><\/th>\n<\/tr>\n
\n
Lecanemab
\n<\/b>Session: Clinical Trials Methodology: #P012
\nTues, Nov 29, 4:00 p.m. \u2013
\nWed, Nov 30, 6:00 p.m.<\/p>\n<\/td>\n
\n
Development and Feasibility of a Data-Driven Approach to Preclinical Alzheimer’s Disease Clinical Trial Recruitment through Centralized Pre-Screening Data Collection<\/p>\n
Authors: D Kirn, et al<\/p>\n<\/td>\n<\/tr>\n
\n
Lecanemab
\n<\/b>Session: New Therapies and Clinical Trials: #P029
\nTues, Nov 29, 4:00 p.m. \u2013<\/p>\n
Wed, Nov 30, 6:00 p.m.<\/p>\n<\/td>\n
\n
Characterization of Amyloid-Beta Protofibrils in Alzheimer\u2019s Disease Brain and the Unique Binding Properties of Lecanemab<\/p>\n
Authors: L Lannfelt, et al<\/p>\n<\/td>\n<\/tr>\n
\n
E2027
\n<\/b>Session: Clinical Trials Results: #P048
\nTues, Nov 29, 4:00 p.m. \u2013<\/p>\n
Wed, Nov 30, 6:00 p.m.<\/p>\n<\/td>\n
\n
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<\/p>\n
Authors: P Sachdev, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Clinical Trials Results: #P037
\nTues, Nov 29, 4:00 p.m. \u2013<\/p>\n
Wed, Nov 30, 6:00 p.m.<\/p>\n<\/td>\n
\n
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<\/p>\n
Authors: S Sivakumaran, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Clinical Trials Results: #P038
\nTues, Nov 29, 4:00 p.m. \u2013
\nWed, Nov 30, 6:00 p.m.<\/p>\n<\/td>\n
\n
Critical Path for Alzheimer’s Disease (CPAD) Consortium: Accelerating and De-Risking Therapeutic Development in AD by Building Regulatory Decision-Making Tools
\nAuthors: S Sivakumaran, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Clinical Trials Biomarkers Including Plasma: #LP66
\nThu, Dec 1, 8:00 a.m. \u2013 6:00 p.m.<\/p>\n<\/td>\n
\n
Baseline Plasma pTau181 Improves Prediction of Cognitive Decline in Amyloid Positive Subjects with Mild Cognitive Impairment
\nAuthors: V Devanarayan, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Epidemiology and Clinical Trials: #P176
\nFri, Dec 2, 8:00 a.m. \u2013 5:00 p.m.<\/p>\n<\/td>\n
\n
Identification of Medical Conditions as Risk Factors for Mild Cognitive Impairment: A US Claims Database Study
\nAuthors: G Li, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Epidemiology and Clinical Trials: #P184
\nFri, Dec 2, 8:00 a.m. \u2013 5:00 p.m.<\/p>\n<\/td>\n
\n
Prevalence Estimations for the Alzheimer’s Disease Continuum in the US Health and Retirement Study
\nAuthors: A Abbas Tahami Monfared, et al<\/p>\n<\/td>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Cognitive and Functional Endpoints:
\n#P139 (Virtual Only)
\nThu, Dec 1, 8:00 a.m. \u2013 6:00 p.m.<\/p>\n<\/td>\n
\n
Dementia Conversion Rate Differences Between Patients with High- and Low-Risk Amnestic Mild Cognitive Impairment in the Real-World: A Prospective, Multicenter, Observational Study
\nAuthors: H Jang, et al<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/p>\n
Sysmex Poster Presentation<\/span><\/b><\/p>\n
\n\n\n\n<\/colgroup>\n\n\n\n

Asset in Development, Session, Time (Pacific Time)<\/b><\/th>\n Presentation Title, Authors<\/b><\/th>\n<\/tr>\n
\n
General AD
\n<\/b>Session: Clinical Trials Biomarkers Including Plasma: #LP84A<\/p>\n
Thu, Dec 1, 8:00 a.m. \u2013 6:00 p.m.<\/p>\n<\/td>\n
\n
Three Group Classification of Participants Based on Fully Automated Plasma \u03b2-amyloid Measurements to Achieve High Positive and Negative Predictive Values<\/p>\n
Authors: K Yamashita, et al<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
<\/p>\n
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.<\/p>\n
<\/p>\n
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.<\/p>\n
<\/p>\n
Media Inquiries:<\/span><\/strong><\/p>\n
Eisai Co., Ltd.<\/span><\/p>\n
\n
\n
Public Relations Department,<\/p>\n
+81-(0)3-3817-5120<\/p>\n<\/div>\n<\/div>\n
<\/p>\n
Eisai Inc. (U.S.)<\/span><\/p>\n
\n
\n
Libby Holman<\/p>\n
+1-201-753-1945<\/p>\n
Libby_Holman@eisai.com<\/a><\/p>\n<\/div>\n<\/div>\n
<\/p>\n
Eisai Europe, Ltd. (Europe, Australia, New Zealand and Russia)<\/span><\/p>\n
\n
\n
EMEA Communications Department<\/p>\n
EMEA-comms@eisai.net<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
Eisai Co., Ltd. (Headquarters: Toyoko, CEO: Haruo Naito, \u201cEisai\u201d) will present the efficacy, safety and biomarker findings from the company\u2019s Phase 3 confirmatory Clarity AD clinical trial for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (A\u03b2) protofibril antibody for the potential treatment of mild cognitive impairment (MCI) due to Alzheimer\u2019s 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\u2019s 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\u2019s AD pipeline, including the company\u2019s investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"class_list":["post-6301","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6301"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=6301"}],"version-history":[{"count":5,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6301\/revisions"}],"predecessor-version":[{"id":6303,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6301\/revisions\/6303"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=6301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=6301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=6301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}