WOODCLIFF LAKE, N.J., Oct. 17, 2018 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announces today that five oral and two poster presentations from its Alzheimer's disease pipeline, including additional data on the BAN2401 Study 201 results, will be highlighted at the 11th Clinical Trials on Alzheimer's Disease (CTAD) conference, October 24-27, 2018 in Barcelona, Spain.
The presentations will highlight three investigational compounds that are being jointly developed by Eisai and Biogen Inc.: BAN2401 and aducanumab, both anti-Aβ antibodies, and elenbecestat, a BACE inhibitor. Data will also be presented on lemborexant, an investigational compound that is being jointly developed by Eisai and Purdue Pharma.
Eisai and Biogen previously announced results from BAN2401 Study 201 during the Alzheimer's Association International Conference (AAIC) in July. Additional BAN2401 data will be presented at the symposium, "Clinical and Biomarker Updates from BAN2401 Study 201 in Early AD," and will be webcast live on October 25. To access the live webcast, please visit https://www.eisai.com/ir/index.html.
There will be an oral elenbecestat presentation which will include additional data on Study 202 results that were initially presented in July 2018 at AAIC in patients with mild cognitive impairment and mild-to-moderate Alzheimer's disease. Elenbecestat is currently being investigated in two ongoing Phase 3 clinical studies, MISSION AD1/2 in patients with early Alzheimer's disease.
Two aducanumab late-breaking presentations, an oral and a poster, will also be shared by Biogen, as well as cumulative safety data from the Phase 1b PRIME long-term extension study of patients with prodromal and mild Alzheimer's disease, which is being conducted by Biogen. Currently, Eisai and Biogen are advancing aducanumab in two Phase 3 clinical studies, ENGAGE and EMERGE.
Eisai and Purdue Pharma will also present preliminary results from a first-in-kind Phase 2 Study 202 of lemborexant – a dual orexin receptor antagonist under development for the treatment of sleep/wake regulation – for Irregular Sleep-Wake Rhythm Disorder (ISWRD) in patients with mild-to-moderate Alzheimer's dementia.
"It is our dedicated research and development team, robust pipeline and successful 30-year legacy in Alzheimer's disease that fuels our commitment to help meet the diverse health care needs of patients living with this devastating disease," said Ivan Cheung, Chairman & CEO, Eisai Inc. "With these emerging data, our hope is that we will be able to accelerate our efforts toward breaking new ground in Alzheimer's disease, relentlessly."
CTAD 2018 presentations:
Abstract title and scheduled presentation date and time
Session No.: OC5
Elenbecestat in MCI-to-Moderate Alzheimer's Disease: Safety and Effectiveness as Measured by Amyloid PET and the ADCOMS Clinical Endpoints
October 25, (Thurs) 9:30 AM – 9:45 AM CEST
Session No.: Keynote 2
What have we Learned from Aducanumab?
October 25, (Thurs) 1:30 PM - 2:00 PM CEST
Session No.: Symposium 3
Clinical and Biomarker Updates from BAN2401 Study 201 in Early AD
October 25, (Thurs) 2:30 PM – 3:30 PM CEST
Session No.: OC11
Safety and Efficacy of Lemborexant for Sleep-Wake Regulation in Patients with Irregular Sleep-Wake Rhythm Disorder and Alzheimer's Disease Dementia
October 25, (Thurs) 3:30 PM – 3:45 PM CEST
Session No.: LB8
Aducanumab Titration Dosing Regimen: 36-Month Analyses From PRIME, A Phase 1B Study in Patients with Early Alzheimer's Disease
October 26, (Fri) 3:15 PM - 3:30 PM CEST
Poster No.: P80
Cumulative Aducanumab Safety Data From PRIME: A Randomized, Double-Blind, Placebo-Controlled, Phase 1B Study
October 24, (Wednesday) – October 27, (Saturday)
Poster No.: LBP19
Aducanumab 48-Month Analyses from PRIME, a Phase 1B Study in Patients with Early Alzheimer's Disease
October 24, (Wednesday) - October 27, (Saturday)
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.
[Notes to editors]
- Please note CTAD embargo policy: All materials submitted to CTAD are embargoed for publication and broadcast until after the officially scheduled date and time of presentation, symposia or poster session.
- Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer's disease pursuant to an agreement concluded with BioArctic in December 2007.
- About the Joint Development Agreement between Eisai and Biogen for Alzheimer's Disease: Eisai and Biogen are widely collaborating on the joint development and commercialization of Alzheimer's disease treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-Aβ protofibril antibody, while Biogen serves as the lead for co-development of aducanumab, Biogen's investigational anti-Aβ antibody for patients with Alzheimer's disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. If approved, the companies will also co-promote the products in major markets, such as the United States, the European Union and Japan.
- Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue Pharma.
About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
SOURCE Eisai Inc.
Type Press Release
Date Released October 17, 2018