Dec 2, 2019 SOURCE: PR NewsWire
Eisai and Biogen's Joint Investigational Asset BAN2401 Data to be Presented at Clinical Trials on Alzheimer's Disease Conference
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 12(th) 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.
Eisai and Biogen Joint Investigational Asset: BAN2401
-- BAN2401 is a humanized monoclonal antibody comprised of A 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 A 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 A
1-40 and A 1-42. 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
Persistence of BAN2401-Mediated Amyloid Reductions
Post-Treatment: A Preliminary Comparison of Amyloid
Session #: LB10 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
BAN2401 in Early Alzheimer's Disease: A Placebo-
Controlled, Double-Blind, Parallel-Group, 18-Month
Poster #: P179 Study with an Open-Label Extension Phase to Confirm
Safety and Efficacy (Clarity AD)
December 6, (Fri) and December 7 (Sat)
---
BAN2401
Binding Profiles of BAN2401 and Aducanumab to
Different Amyloid-Beta Species
Session #: OC29
December 7, (Sat) 11:30 a.m.-11:45 a.m.
---
Diagnostic
Prediction of Amyloid Pathology by the Plasma A 1-
42/A 1-40 Ratio Measured with Fully Automated
Poster #: P75 Immunoassay System (HISCL(TM) Series)
December 5, (Thurs)
---
Diagnostic
Clinical Utility of Plasma Amyloid Beta Measurements by
Immunoaffinity Enrichment and LC-MS/MS
Poster #: P81
December 5, (Thurs)
---
Diagnostic
Staging Early Alzheimer's Disease Using the Alzheimer's
Disease Composite Score (ADCOMS)
Poster #: P136
December 6, (Fri) and December 7, (Sat)
---
Lemborexant
Using Network Analysis and Machine Learning Methods
to Evaluate the Efficacy of Lemborexant in Patients with
Poster #: P3 Irregular Sleep Wake Rhythm Disorder and Alzheimer's
Disease Dementia
December 5, (Thurs)
---
Elenbecestat
The Cognitive Task Force: A Novel Approach to
Improving the Efficiency of Cognitive Screening for the
Poster #: P24 Elenbecestat MissionAD Global Phase 3 Studies in Early
Alzheimer's Disease
December 5 (Thurs)
---
Elenbecestat
Asian and Non-Asian Countries Screen Subjects with
Similar MMSE Scores for the Elenebecestat MissionAD
Poster #: P149 Global Phase 3 Studies in Early Alzheimer's Disease
December 6, (Fri) and December 7, (Sat)
---
Elenbecestat
Amyloid Positive Subject Characteristics in the
Elenbecestat MissionAD Phase 3 Program
Poster #: P46
December 5, (Thurs)
---
Elenbecestat
Association Between Neuraceq Levels and [18F]PI-2620
Tau PET Tracer Accumulation in Baseline Scans of the
Session #: LB16 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 (A ) 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 A 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
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