WOODCLIFF LAKE, N.J.,
May 13, 2019 /PRNewswire/ -- The
Alzheimer's Clinical Trials Consortium (ACTC) and Eisai Co., Ltd.
(Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") announced
today that the investigational oral BACE (beta amyloid cleaving
enzyme) inhibitor elenbecestat (development code: E2609) and the
investigational anti-amyloid beta (Ab) protofibril antibody
BAN2401, which are currently being evaluated as treatments for
early Alzheimer's disease (AD), have been selected by the ACTC as
treatments to be evaluated in upcoming clinical studies targeting
primary prevention (A3 Study) and secondary prevention (A45 Study)
of AD. These studies will be conducted with funding from various
sources including the United States National Institute on Aging
(NIA), part of the National Institutes of Health, and Eisai.
The ACTC, which is an NIA-funded clinical trial network with 35
primary clinical study sites across the
United States, aims to accelerate and expand studies for
therapies in AD and related dementias across the spectrum from
pre-symptomatic to more severe stages of disease. ACTC was
established with grant funding from the NIA in December 2017. The A3 and A45 Studies are led by
three academic principal investigators: Dr. Paul Aisen from University
of Southern California, and Drs. Reisa Sperling and Keith
Johnson from Brigham and Women's Hospital and Massachusetts
General Hospital, Harvard Medical
School.
"The A3 and A45 Studies should provide critically important
answers about the optimal time to intervene with anti-amyloid
therapy, with the hope that starting treatment much earlier in the
disease process may be advantageous in preventing future cognitive
decline," said Dr. Sperling, Director, Center for Alzheimer
Research and Treatment at Brigham and Women's Hospital and
co-Principal Investigator, ACTC.
Dr. Aisen, Director of the University of
Southern California Alzheimer's Therapeutic Research
Institute, which serves as the coordinating center for the ACTC,
noted that "The mission of the ACTC includes the development of
public-private partnerships to conduct trials of promising
candidate therapies. This collaboration with Eisai will allow us to
test two promising therapies in innovative studies that may advance
the field."
The A3 Study aims to get closer to the goal of primary
prevention of AD, through preventing amyloid build-up in the brain.
The study targets cognitively normal individuals who are currently
below the threshold for amyloid elevation on amyloid PET but are at
high risk for further Ab accumulation. The A3 study will be a
global, multicenter, double-blind, randomized trial to compare the
effects of two doses of elenbecestat vs. placebo, to test whether a
BACE inhibitor can slow brain amyloid accumulation at this very
early stage of disease. The A3 Study will also measure accumulation
of tangle pathology using tau PET and exploratory cognitive
outcomes.
The A45 study will target the preclinical (pre-symptomatic)
stage of AD. The study will enroll clinically normal participants
(no/minor cognitive impairment) who have elevated levels of amyloid
in brain and are at high risk for progression to mild cognitive
impairment and AD dementia. The A45 study will be a global,
multicenter, double-blinded, placebo-controlled, randomized trial
of a treatment regimen consisting of an anti-Aβ antibody and a BACE
inhibitor to prevent cognitive decline and delay biomarkers of
pathological progression versus placebo. In the active arm,
individuals will be provided first with BAN2401 with the goal to
clear amyloid deposits and Aβ protofibrils from the brain, after
which they will be maintained on elenbecestat with the aim of
decreasing the production of Aβ and preventing the reaccumulation
of amyloid plaques and protofibrils.
"We are excited to partner with the ACTC group with trials
focusing on therapies for earlier stages of AD and will thus allow
us to understand the benefit of BAN2401 and elenbecestat across a
broader spectrum of the disease," said Lynn
Kramer, MD, Chief Clinical Officer and Chief Medical
Officer, Neurology Business Group, Eisai.
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.
Discovered through a strategic research alliance between Eisai
and BioArctic AB (Headquarters: Sweden), BAN2401 is a humanized monoclonal
antibody for AD. BAN2401 selectively binds to neutralize and
eliminate soluble, toxic Aβ aggregates (protofibril) that are
thought to be a causative factor for AD. This suggests that BAN2401
may exert disease modifying effects and may have potential to slow
the progression of AD. Currently, a global Phase III clinical study
(Clarity AD) of BAN2401 in early AD is underway.
Eisai and Biogen Inc. (Nasdaq: BIIB) (Headquarters: Cambridge, Massachusetts, United States) are collaborating on the joint
development and commercialization of AD treatments.
Trials will be starting early 2020. Individuals who may be
interested in participating in these trials may sign up for
additional information at www.A3A45.org.
Media
Inquiries
|
Public Relations
Brigham and Women's Hospital
CONTACT:
Lori
Schroth
Office: 617-525-6374
| Mobile: 617-459-2111
lschroth@bwh.harvard.edu
|
Public Relations
University of Southern California
CONTACT:
Leigh
Hopper
USC Central
Communications
Media Relations
Specialist
310-308-0405
http://pressroom.usc.edu/
|
Public Relations
Department
Eisai Co.,
Ltd.
TEL:
+81-(0)3-3817-5120
|
< Notes to editors >
1. About The
Alzheimer's Clinical Trials Consortium (ACTC)
The ACTC,
funded by the National Institute on Aging at the National
Institutes of Health, provides the infrastructure for academic
clinical trials in Alzheimer's Disease and related dementias.
The consortium, based at the University of
Southern California, Harvard
University and the Mayo Clinic, includes expert units to
support clinical trials design, biostatistics, informatics, medical
safety, regulatory oversight, recruitment, clinical operations,
data management, site monitoring, a biomarker laboratory and
repository, and neuroimaging. The ACTC includes 35 primary
clinical sites across the United
States.
2. About Eisai Co.,
Ltd.
Eisai Co., Ltd. is a leading global research and
development-based pharmaceutical company headquartered in
Japan. We define our corporate
mission as "giving first thought to patients and their families and
to increasing the benefits health care provides," which we call our
human health care (hhc) philosophy. With
approximately 10,000 employees working across our global network of
R&D facilities, manufacturing sites and marketing subsidiaries,
we strive to realize our hhc philosophy by delivering
innovative products to address unmet medical needs, with a
particular focus in our strategic areas of Neurology and
Oncology.
Leveraging the experience gained from the development and
marketing of Aricept®, a treatment for Alzheimer's
disease and dementia with Lewy bodies, Eisai has been working to
establish a social environment that involves patients in each
community in cooperation with various stakeholders including the
government, healthcare professionals and care workers, and is
estimated to have held over ten thousand dementia awareness events
worldwide. As a pioneer in the field of dementia treatment, Eisai
is striving to not only develop next generation treatments but also
to develop diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit
www.eisai.com.
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SOURCE Eisai