• 11 Nov 2021
• Admin
• News Article

Eisai Presents Late-Breaker Updates On Lecanemab Clinical, Biomarker And Safety Data From Phase 2B Study Core And Open-Label Extension Across Five Years At Clinical Trials On Alzheimer'S Disease (Ctad) Conference

Tokyo And Cambridge, Mass., Nov. 10, 2021 /Prnewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, Ceo: Haruo Naito, "Eisai") And Biogen Inc. (Nasdaq: Biib, Corporate Headquarters: Cambridge, Massachusetts, Ceo: Michel Vounatsos, "Biogen") Announced Today Results Of New Clinical, Biomarker And Safety Assessments Of Brain Amyloid Reduction And Five-Year Clinical Status Of People Living With Early Alzheimer'S Disease (Ad) From The Lecanemab Phase 2B 201 And The Open-Label Extension (Ole) Studies. The Findings Were Presented And Discussed In A Late-Breaking Roundtable Session With Esteemed Clinical Researchers At The 2021 Clinical Trials On Alzheimer'S Disease (Ctad) Conference, November 9-12, 2021, In Boston, Massachusetts And Virtually. Eisai Recently Initiated A Rolling Submission Of A Biologics License Application (Bla) For Lecanemab, An Investigational Anti-Amyloid Beta (A?) Protofibril Antibody, For The Treatment Of Early Ad, To The U.S. Food And Drug Administration (Fda) Under The Accelerated Approval PathwayAn Ole With 10 Mg/Kg Iv Biweekly Lecanemab Dosing Was Implemented After Analysis Of The 18-Month, Core Phase (Study 201, Alz Res Therapy 13;21) With An Intervening Off-Treatment Period (Gap Period) Ranging From 9-59 Months (Mean 24 Months). The Ole Phase Evaluated The Effect Of Lecanemab On Amyloid Pet Over 12 Months Of Treatment, Including Earlier Time Points (3 And 6 Months) Than In The Core Phase (12 And 18 Months). This Study Design Provided The Opportunity To Explore The Biomarker And Clinical Effects Of Stopping And Restarting Lecanemab Across Five Years Of Disease Trajectory.The Updated Assessment Of The Ole Phase Showed That Treatment With Lecanemab Resulted In Reduction Of Brain Amyloid Levels In As Early As 3 Months Based On Ole Data And Robust Clearance Of Amyloid Plaque With More Than 80% Of Participants (10/12) Achieving Amyloid Negative Status By 12-18 Months Of Treatment As Measured By Pet (Visual Read). These Results Are Consistent With Core Phase Results. The 201 Study Core Data Suggested That Clinical Efficacy (Adcoms) Is Correlated With Amyloid Reduction (Pet Suvr) At Both The Population (Correlation Coefficients=0.832, P-Value=0.080) And Subject Levels (Correlation Coefficients=0.201, Slope=0.199, P=0.036). Amyloid Pet Levels Were Significantly Reduced By Quantitative Assessment In Newly Treated Ole Subjects In As Early As 3 Months After Initiation Of Treatment. Additionally, The Core Data Suggested That Clinical Efficacy Is Correlated With Plasma A? At Both The Population (Correlation Coefficients=-0.306, Not Significant) And Subject Levels (Correlation Coefficients=-0.208, Slope=-3.957, P-Value=0.050).