Press Releases

Eisai and Biogen's Joint Investigational Asset BAN2401 Data to be Presented at Clinical Trials on Alzheimer's Disease Conference

New Data from Eisai's Robust Dementia Pipeline Will Be Shared, Including Analyses of Investigational Alzheimer's Disease Compounds and Diagnostic Methods

Dec 2, 2019

WOODCLIFF LAKE, N.J., Dec. 2, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today new data from the company's rich dementia pipeline, including BAN2401, lemborexant and diagnostics methods, will be presented at the 12th Clinical Trials on Alzheimer's Disease (CTAD) conference, December 4-7, 2019 in San Diego. Data will be communicated in both oral and poster presentations.

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Eisai and Biogen Joint Investigational Asset: BAN2401

  • BAN2401 is a humanized monoclonal antibody comprised of Aβ protofibrils as an antigen, based on the research of cases of Swedish familial Alzheimer's disease (AD) with Arctic mutation, which concluded abnormal accumulation of Aβ protofibrils may be a cause of AD onset.
  • Preliminary findings from a Phase 2 open-label extension study of BAN2401 (Study 201) evaluating amyloid status in patients with early AD will be shared during the session titled Late Breaking Oral Communication, scheduled for December 5 at 11:15 a.m.
  • Study design for the ongoing, open-label extension of the Phase 3 Clarity AD trial (Study 301) will also be communicated in a poster presentation.

"The breadth of data Eisai will present demonstrates our continued dedication to bring patients therapies for Alzheimer's disease and its symptoms as soon as possible," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai. "We look forward to sharing key data and discussing the scientific rationale that the amyloid pathway plays a key role in the pathophysiology of Alzheimer's disease."

Eisai Pipeline Assets
Additional studies will be presented that further explore key topics affecting AD patients.

  • In partnership with Sysmex, Eisai will share two posters based on key findings gleaned from Sysmex's novel, fully-automated biomarker immunoassay system, which explored the diagnostic utility of plasma Aβ1-40 and Aβ1-42. Eisai seeks to derive AD composite scores (ADCOMS) to stage severity of mild cognitive impairment (MCI) and dementia syndromes and to evaluate the utility of the derived scores in distinguishing patients across stages, especially patients with MCI due to AD from the mild AD dementia stage.
  • Eisai will present key learnings from a Phase 2 proof-of-concept treatment study of lemborexant compared with placebo in patients with Irregular Sleep-Wake Rhythm Disorder (ISWRD), a circadian rhythm sleep disorder, and mild-to-moderate AD dementia. Results are based on wearable device data, network analysis and machine learning methods.

"In addition to a robust pipeline of potential disease-modifying 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," said Ivan Cheung, Chairman and CEO, Eisai Inc. "Eisai has dedicated more than 30 years to research, development and commercialization in our relentless pursuit of treatments for Alzheimer's disease and dementia."

CTAD 2019 Presentations by Asset

Pipeline Asset, Session Number

Title and Scheduled Presentation Date and Time
(PST)

BAN2401

Session #: LB10

Persistence of BAN2401-Mediated Amyloid Reductions
Post-Treatment: A Preliminary Comparison of Amyloid
Status Between the Core Phase of BAN2401-G000-201
and Baseline of the Open-Label Extension Phase in
Subjects With Early Alzheimer's Disease

December 5, (Thurs) 11:15 a.m.-11:30 a.m.

   

BAN2401

Poster #: P179

BAN2401 in Early Alzheimer's Disease: A Placebo-
Controlled, Double-Blind, Parallel-Group, 18-Month
Study with an Open-Label Extension Phase to Confirm
Safety and Efficacy (Clarity AD)

December 6, (Fri) and December 7, (Sat)

   

BAN2401

Session #: OC29

Binding Profiles of BAN2401 and Aducanumab to
Different Amyloid-Beta Species

December 7, (Sat) 11:30 a.m.-11:45 a.m.

   

Diagnostic

Poster #: P75

Prediction of Amyloid Pathology by the Plasma Aβ1-
42/Aβ1-40 Ratio Measured with Fully Automated
Immunoassay System (HISCL™ Series)

December 5, (Thurs)

   

Diagnostic

Poster #: P81

Clinical Utility of Plasma Amyloid Beta Measurements by
Immunoaffinity Enrichment and LC-MS/MS

December 5, (Thurs)

   

Diagnostic

Poster #: P136

Staging Early Alzheimer's Disease Using the Alzheimer's
Disease Composite Score (ADCOMS)

December 6, (Fri) and December 7, (Sat)

   

Lemborexant

Poster #: P3

Using Network Analysis and Machine Learning Methods
to Evaluate the Efficacy of Lemborexant in Patients with
Irregular Sleep Wake Rhythm Disorder and Alzheimer's
Disease Dementia

December 5, (Thurs)

   

Elenbecestat

Poster #: P24

The Cognitive Task Force: A Novel Approach to
Improving the Efficiency of Cognitive Screening for the
Elenbecestat MissionAD Global Phase 3 Studies in Early
Alzheimer's Disease

December 5, (Thurs)

   

Elenbecestat

Poster #: P149

Asian and Non-Asian Countries Screen Subjects with
Similar MMSE Scores for the Elenebecestat MissionAD
Global Phase 3 Studies in Early Alzheimer's Disease

December 6, (Fri) and December 7, (Sat)

   

Elenbecestat

Poster #: P46

Amyloid Positive Subject Characteristics in the
Elenbecestat MissionAD Phase 3 Program

December 5, (Thurs)

   

Elenbecestat

Session #: LB16

Association Between Neuraceq Levels and [18F]PI-2620
Tau PET Tracer Accumulation in Baseline Scans of the
Elenbecestat MissionAD Program

December 6, (Fri) 8:30 a.m.-8:45 a.m.

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 the Joint Development between Eisai and Biogen for Alzheimer's Disease

 

Eisai and Biogen are collaborating on the joint development and commercialization of Alzheimer's disease treatments. Biogen serves as the lead in the co-development of aducanumab and Eisai serves as the lead in the co-development of BAN2401, anti-amyloid beta (Aβ) protofibril antibodies, and the companies plan to pursue marketing authorizations for aducanumab and BAN2401 worldwide. If approved, the companies will also co-promote aducanumab and BAN2401 in major markets, such as the United States, the European Union and Japan. Both companies will equally split overall costs, including research and development expenses. Eisai will book all sales for BAN2401 following marketing approval and launch, and profits will be equally shared between the companies.

   

2.

About Aducanumab

 

Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of early Alzheimer's disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the CDR-SB score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by MMSE, ADAS-Cog 13, and ADCS-ADL-MCI.

   

3.

About BAN2401

 

BAN2401 is an investigational humanized monoclonal antibody for Alzheimer's disease 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 Alzheimer's disease. 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 Alzheimer's disease 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.

   

4.

About BAN2401 Clarity AD Phase 3 Clinical Trial

 

Clarity AD will evaluate the efficacy and safety of BAN2401 versus placebo and is currently enrolling at more than 130 active sites in eight countries. An increasing number of clinical trial sites will ultimately enroll up to 1,566 patients with early Alzheimer's disease (Mild Cognitive Impairment due to Alzheimer's disease and Mild Alzheimer dementia) as quickly as possible. Additionally, BAN2401 is being evaluated in people with asymptomatic preclinical Alzheimer's disease, supported by the NIH-funded Alzheimer's Clinical Trials Consortium (ACTC) in the A3/A45 Studies, recruitment for these trials will begin shortly.

   

5.

About Elenbecestat

 

Working with our partner Biogen, we are continuing to analyze our data from the MissionAD elenbecestat trial, and will report out the results at future meetings.

   

6.

About the Collaboration between Eisai and BioArctic for Alzheimer's Disease

 

Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The commercialization agreement on the BAN2401 antibody was signed in December 2007, and the development and commercialization agreement on the antibody BAN2401 back-up for Alzheimer's disease, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has no development costs for BAN2401 in Alzheimer's disease.

   

7.

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.

   

8.

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.

   

9.

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). 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.

 

Contact:
Eisai Inc.
Libby Holman
201-753-1945
Libby_Holman@eisai.com                                                          

 

SOURCE Eisai Inc.