WOODCLIFF LAKE, N.J.,
May 10, 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 potential
treatments for early Alzheimer's disease (AD), have been selected
by the ACTC as potential 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 the 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 proposed study
design 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 proposed study design 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 potential 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.
Trials will be starting early 2020.
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/
|
Libby
Holman
Eisai Inc.
201-753-1945 or
Libby_Holman@Eisai.com
|
[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 Elenbecestat
Discovered by
Eisai, elenbecestat is an investigational 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 BAN2401
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.
4. About Eisai Inc.
Eisai is a leading
global research and development-based pharmaceutical company
headquartered in Japan, with
approximately 10,000 employees worldwide. 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. We strive to realize our hhc
philosophy by delivering innovative products in therapeutic areas
with high unmet medical needs, including Oncology and Neurology. In
the spirit of hhc, we take that commitment even further by applying
our scientific expertise, clinical capabilities and patient
insights to discover and develop innovative solutions that help
address society's toughest unmet needs, including neglected
tropical diseases and the Sustainable Development Goals.
For more information about Eisai, please visit www.eisai.com
(for global), us.eisai.com (for U.S.) or www.eisai.co.uk (for
U.K.), and connect with us on Twitter (U.S. and global) and
LinkedIn (for U.S.).
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