New Data From Long-Term Extension of Phase 1B Study of Investigational Alzheimer's Disease Treatment Aducanumab Presented at ...
2017年11月6日 - 8:37PM
JCN Newswire (英)
Eisai Co., Ltd. announced today that Biogen Inc. (Nasdaq: BIIB)
presented new data from the long-term extension (LTE) of its
ongoing Phase 1b study of aducanumab, an investigational treatment
for Alzheimer's disease at the 10th Clinical Trials on Alzheimer's
Disease (CTAD) meeting, Boston, Massachusetts, United States, from
November 1 to 4.
As of October 23, 2017, Eisai and Biogen entered into a global
collaboration agreement to jointly develop and commercialize
aducanumab.
The data include results from patients in the Phase 1b study of
aducanumab who were treated with a gradually increased dose of
aducanumab for up to 24 months and those who were treated with a
fixed dose of 3, 6 or 10 mg/kg aducanumab for up to 36 months.
- Two-year data from Phase 1b study suggest a continued benefit on
amyloid plaque reduction and the rate of clinical decline in the
titration regimen group, which received a gradually increased
aducanumab dose
- The results at two years in the titration regimen group were
consistent with the dose- and time-dependent results observed in
the treatment groups that received a fixed-dose of 3, 6 or 10 mg/kg
aducanumab during the same time period
- Results from treatment groups that received a fixed-dose of 3, 6
or 10 mg/kg aducanumab for up to three years were consistent with
previously reported analyses from the Phase 1b study and support
the design of the ongoing Phase 3 studies of aducanumab for early
Alzheimer's disease
The results from the Phase 1b study of aducanumab including the new
data from the LTE have further deepened Eisai's conviction in the
amyloid hypothesis. Eisai plans to advance co-development with
Biogen and hopes to create the world's potentially first new
treatment for Alzheimer's disease based on the amyloid hypothesis
as early as possible.
About aducanumab (BIIB037)
Aducanumab (BIIB037) is an investigational drug being developed for
the treatment of AD. Aducanumab is a human recombinant monoclonal
antibody (mAb) derived from a de-identified library of B cells
collected from healthy elderly subjects with no signs of cognitive
impairment or cognitively impaired elderly subjects with unusually
slow cognitive decline using Neurimmune's technology platform
called Reverse Translational Medicine (RTM). Biogen licensed
aducanumab from Neurimmune under a collaborative development and
license agreement. Aducanumab is being jointly developed by Biogen
and Eisai, with Eisai having exercised its option to co-develop and
co-promote aducanumab on October 23, 2017.
Aducanumab is thought to target aggregated forms of beta amyloid
including soluble oligomers and insoluble fibrils which can form
into amyloid plaque in the brain of AD patients. Based on
pre-clinical and Phase 1b data to date, treatment with aducanumab
has been shown to reduce amyloid plaque levels.
In August 2016 aducanumab was accepted into the European Medicines
Agency's PRIME program. In September 2016 the U.S. Food and Drug
Administration accepted aducanumab into its Fast Track program and
in April 2017 aducanumab was accepted into the Japanese Ministry of
Health, Labour and Welfare's (MHLW) SAKIGAKE(1) Designation
System.
(1) SAKIGAKE aims at shortening premarket review period for
innovative new medical products that satisfy certain criteria, such
as severity of intended indication, by designating such products
during the early stages of development, and providing prioritized
consultation services and premarket pharmaceutical affairs review.
The target review period for the designated products may be reduced
to as short as 6 months, half the standard review period of 12
months for typical new pharmaceutical products.
About the Phase 1b study
The Phase 1b study is a randomized, double-blind,
placebo-controlled, multiple-dose study evaluating the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and
clinical effects of aducanumab in patients with prodromal or mild
Alzheimer's disease. The study includes fixed dosing at 1, 3, 6 and
10 mg/kg as well as an arm with a titration regimen in which
patients received a gradually increased dose of aducanumab until
they reach a maximum dose of 10 mg/kg.
In the Phase 1b LTE, the most commonly reported adverse events were
headache, fall and amyloid-related imaging abnormalities (ARIA). Of
the 185 patients dosed with aducanumab in the Phase 1b study, 46
patients experienced ARIA-E (edema). There were no new cases of
ARIA-E in patients who continued on the same dose of
aducanumab.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
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