New Data in 2 Oral and 13 Poster Presentations about Eisai's Latest Dementia Pipeline, Including BAN2401, Elenbecestat and Lemborexant, to be Presented at Alzheimer's Association International Conference

WOODCLIFF LAKE, N.J., July 11, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today that two oral and 13 poster presentations about its Alzheimer's Disease (AD), dementia pipeline will be presented at the 2019 Alzheimer's Association International Conference (AAIC), July 14-18, in Los Angeles.

Eight of the presentations provide new information specifically related to two of Eisai's AD investigational compounds: BAN2401 and elenbecestat.

• BAN2401 is a monoclonal antibody that selectively binds and clears Aβ protofibrils, a soluble toxic Aβ species thought to contribute to AD pathophysiology. BAN2401 is being studied in patients with early AD in the Phase 3 CLARITY AD clinical trial, which is currently enrolling.
• Elenbecestat is a novel oral small molecule, which selectively inhibits BACE1, optimally reducing production of Aβ. Elenbecestat is currently being studied in early AD in two Phase 3 clinical trials, MISSIONAD 1 and 2.

BAN2401 and elenbecestat are being jointly developed by Eisai and Biogen.

"Two key priorities for Alzheimer's Disease treatment are clearing Aβ protofibrils and blocking the progression of the Aβ cascade," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The upcoming presentations of BAN2401 and elenbecestat information will add to the growing body of scientific knowledge needed to continue to inform research as we seek effective therapies to treat this devastating disease."

Eisai and Sysmex have been working to meet the needs of patients by exploring cost-effective, easy-to-use, blood-based AD diagnosis methods. A reliable solution is essential for early diagnosis and for clinical trial screening. This preclinical research is about the correlation of cerebrospinal fluid and plasma Aβ levels measured by a newly developed automated protein assay system will be presented. 

Other dementia posters focus on Eisai's E2814, which is an anti-tau therapeutic antibody for AD, as well as approaches to modeling the effectiveness of hypothetical disease-modifying treatments for AD.

AAIC's Featured Research Session on Monday, July 15 will include a presentation about the investigational agent lemborexant, "Response to Treatment with Lemborexant: Subjects with Irregular Sleep-Wake Rhythm Disorder and Alzheimer's Disease Dementia." Lemborexant is being studied for multiple sleep-wake disorders and is currently under review with the FDA as a potential treatment of insomnia for adults who have difficulty falling asleep and staying asleep.

"The breadth of data we will present at AAIC represents important progress in Eisai's 35-year relentless pursuit of treatments across all stages of Alzheimer's Disease and dementia," said Ivan Cheung, Chairman and CEO, Eisai Inc. "In addition to a robust pipeline of disease-modifying investigational compounds targeting Alzheimer's pathological hallmarks of Amyloid, Tau and Neurodegeneration, Eisai is researching other disease-modifying agents and novel therapies aiming to treat the clinical symptoms of dementia, such as cognition and sleep disorders. Our leadership and commitment is further demonstrated by this week's opening of the first research center focused on immunodementia, Eisai's Center for Genetics Guided Dementia Discovery in Cambridge, Massachusetts."

In addition to the dementia data presentations, Eisai will sponsor an interactive satellite symposium focusing on the rationale and opportunities for drug development in preclinical AD – clinically normal people with increased cerebral amyloid deposition who are at risk for developing AD. Our expert faculty will review the pathophysiologic pathways underlying AD, discuss the Aβ/Tau/Neurodegeneration (A/T/N) system for classifying AD biologically and outline approaches for clinical trials in preclinical AD. The symposium will take place Tuesday, July 16 (details below).

Relevant Eisai Data and AAIC 2019 Presentations and Events:

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]

1. About BAN2401

BAN2401 is an investigational humanized monoclonal antibody for Alzheimer's Disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in AD. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.

2. About Elenbecestat

Discovered by Eisai, elenbecestat is an investigational next-generation oral candidate for the treatment of AD that inhibits BACE. By inhibiting BACE, a key enzyme in the production of Aβ, elenbecestat reduces Aβ production, which reduces amyloid aggregates in the brain. In this regard, elenbecestat is thought to exert disease modifying effects and may have potential to slow the progression of AD. Currently, a global Phase III clinical study program (MISSION AD) of elenbecestat in early AD is underway.

3. About the Joint Development between Eisai and Biogen for AD

Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of elenbecestat, a BACE inhibitor, and BAN2401, an anti-Aβ protofibril antibody and the companies plan to pursue marketing authorizations for the two 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. As to BAN2401 and elenbecestat, both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for elenbecestat and BAN2401 following marketing approval and launch, and profits will be equally shared between the companies.

4. About the Collaboration between Eisai and Sysmex

Eisai and Sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in February, 2016. Leveraging each other's technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.

5. About E2814

An anti-tau monoclonal antibody, E2814 is being developed as a disease modifying agent for Alzheimer's disease and other tauopathies, Phase I clinical studies are under preparation. The drug candidate was discovered as part of the research collaboration between Eisai and University College London, and is designed to prevent the spreading of tau protein "seeds" within the brains of affected individuals.

6. About Lemborexant

Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep. Eisai is investigating lemborexant as a potential treatment option for multiple sleep-wake disorders, such as insomnia. Additionally, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.

7. 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.

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SOURCE Eisai Inc.