TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Apr 20, 2021 09:23 JST
Source:
Eisai
Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer's Disease
Published in Peer-Reviewed Journal, Alzheimer's Research and Therapy
Lecanemab Phase 3 Clarity AD Clinical Trial Completed Enrollment
TOKYO, Apr 20, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer's Research and Therapy. The manuscript describes results from Study 201, a Phase 2b proof- of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (Abeta) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm. The results of Study 201 were presented at the Alzheimer's Association International Conference and Clinical Trials on Alzheimer's Disease in 2018.
The lecanemab Clarity AD Phase 3 clinical trial completed enrollment last month with 1,795 symptomatic patients with early Alzheimer's disease (AD). Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early AD. Additionally, the Phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in individuals with preclinical AD, defined as patients that are clinically asymptomatic, but have intermediate or elevated brain Aβ levels.
"Amyloid beta aggregates are thought to be more toxic than monomers, and we hypothesized that reducing these could represent an effective treatment approach in early stages of Alzheimer's disease," said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas. "These results from lecanemab's Phase 2b clinical trial are encouraging and the scientific community is looking forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway."
"These supportive findings from the lecanemab Phase 2b study and the initiation of two Phase 3 studies are exciting for the field and provide the opportunity to further explore the key role of the amyloid beta pathway in the pathophysiology of Alzheimer's disease," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Eisai's precision pipeline approach envisions an Alzheimer's disease treatment paradigm based on a person's pathophysiological biomarker profile along the disease continuum. We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families."
For more information, visit
https://www.eisai.com/news/2021/pdf/enews202128pdf.pdf
.
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
More Press release >>
Latest Press Release
DENSO Acquires Axia Vegetable Seeds to Realize Sustainable Agriculture
Jul 04, 2025 16:20 JST
MHIET Launches 450kW Gas Cogeneration System Capable of Hydrogen Co-Firing
Jul 04, 2025 15:13 JST
Yachiyo Engineering and NEC launch adaptation finance study in Indonesia to calculate the adaptation value of disaster prevention measures
Jul 04, 2025 13:25 JST
Fujitsu to implement store monitoring solution for METRO Inc. in Canada, enhancing operational efficiency and policy compliance
Jul 04, 2025 13:19 JST
Fujitsu to develop ETF trading platform based on TSE's CONNEQTOR and provide it to Australian Securities Exchange
Jul 03, 2025 11:14 JST
Mitsubishi Motors Launches the All-New Grandis for the European Market
Jul 02, 2025 12:10 JST
Valuufy partners with Mainichi Future Creation Lab, Supporting New Approaches to Business Sustainability
Jul 02, 2025 12:00 JST
Fujitsu launches solution to enhance customers' global supply chain resilience
Jul 02, 2025 11:32 JST
MHI Receives Order to Supply Four Circulating Water Pumps for Units 5 and 6 of Sanmen Nuclear Power Plant in China Under Collaboration with Dongfang Electric Machinery
Jul 02, 2025 11:30 JST
Multi-purpose Arena in Odaiba Aomi Area TOYOTA ARENA TOKYO Construction Completed
Jul 01, 2025 22:56 JST
1Finity, a Fujitsu company, commences operations and reveals brand identity
Jul 01, 2025 22:53 JST
MHI Thermal Systems Begins Field Test of Jointly Developed "Surplus Renewable Energy Absorption and Release System"
Jul 01, 2025 22:40 JST
Japan's Telecommunications Carriers Strengthen Disaster Response Through Collaborative Information Sharing
Jul 01, 2025 22:30 JST
JCB and Mandai Wildlife Group Deepen Partnership with exclusive discounts for JCB cardmembers
Jul 01, 2025 16:00 JST
Fujitsu provides Japan's first AI-powered cloud-based library search service
Jul 01, 2025 11:30 JST
JCB Brings Apple Pay to Cardmembers in Vietnam
Jul 01, 2025 11:15 JST
First Shipment of LNG from the LNG Canada Project
Jul 01, 2025 11:00 JST
Approval in Principle (AiP) for World's First LCO2 / Methanol Carrier
Jun 30, 2025 20:30 JST
Acropolis Rally Greece: Day 4 Sunday success and second overall for TOYOTA GAZOO Racing's Ogier
Jun 30, 2025 20:15 JST
Mitsubishi Fuso-Hino Merger: 4 Firms Collaborate for the Future of Commercial Vehicles
Jun 30, 2025 20:10 JST
More Latest Release >>