New Phase 3 Data Show Positive Correlation Between ADUHELM™
Treatment Effect on Biomarkers and Reduction in
Clinical Decline in Alzheimer’s Disease
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan)
announced that data from approximately 7,000 plasma samples from
more than 1,800 patients in the ADUHELM™ (aducanumab-avwa) Phase 3
clinical trials showed a statistically significant correlation
between plasma p-tau reduction and less cognitive and functional
decline in Alzheimer’s disease. Reductions in plasma p-tau181 were
also correlated with a lowering of amyloid beta plaque. The
pre-specified analysis of plasma samples was conducted by an
independent lab, drawing from the two pivotal ADUHELM Phase 3
EMERGE and ENGAGE trials. The findings were presented today at the
Clinical Trials on Alzheimer’s Disease conference (CTAD), held
November 9-12 virtually and in Boston, Massachusetts.
The analysis highlighted that ADUHELM significantly reduced tau
pathology, a defining feature of Alzheimer’s disease, as measured
by plasma p-tau181, when compared to placebo. The effect was
greater with higher doses and longer duration of ADUHELM treatment.
Greater reduction in plasma p-tau181 also had a statistically
significant correlation with less decline in cognition and function
in ADUHELM-treated patients. Furthermore, the analysis demonstrated
a statistically significant correlation between change in plasma
p-tau181 and lowering of amyloid beta plaque, showing the effect of
ADUHELM on the two core pathological features of Alzheimer’s
disease.
“We now have robust and concordant data that ADUHELM has effect
on two core defining pathologies of Alzheimer’s disease, and
substantial evidence of treatment correlation between changes in
plasma p-tau181 and the slowing of disease progression,” said
Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development
at Biogen. “We are committed to continuing to generate data, and we
believe these new findings can help inform treatment choice and
advance Alzheimer’s research including in diagnosis and disease
monitoring.”
The findings showed that ADUHELM significantly lowered plasma
p-tau181 in a dose- and time-dependent manner vs. placebo in both
Phase 3 trials. In the EMERGE high-dose group, p-tau decreased 13%
from baseline (p<0.001), while placebo rose 8%; in the ENGAGE
high-dose group, p-tau decreased 16% from baseline (p<0.001),
while placebo rose 9%.
Greater reduction in plasma p-tau181 was correlated with less
clinical decline in all four clinical outcome measures in the Phase
3 trials. Correlation values across these endpoints were as follows
for EMERGE and ENGAGE, respectively: Clinical Dementia Rating Sum
of Boxes Score (CDR-SB) R = 0.11 (p = 0.0166) and R = 0.14 (p =
0.0005); Mini-Mental State Examination (MMSE) R = -0.21 (p <
0.0001) and R = -0.15 (p = 0.0002); Alzheimer’s Disease Assessment
Scale–Cognitive Subscale (ADAS-Cog 13) R = 0.17 (p = 0.0001) and R
= 0.15 (p = 0.0002); and Alzheimer’s Disease Cooperative
Study/Activities of Daily Living scale adapted for MCI
(ADCS-ADL-MCI) R = -0.12 (p = 0.0086) and R = -0.14 (p =
0.0010).
Changes in plasma p-tau181 was also significantly correlated
with change in amyloid beta positron emission tomography (PET)
standardized uptake value ratio (SUVR): EMERGE R = 0.38, p <
0.0001; ENGAGE R = 0.42, p < 0.0001.
“These data not only show an important link between the ability
of ADUHELM to clear amyloid beta plaque and reduce plasma p-tau
levels, but also significantly correlate those reductions with
slowing cognitive decline,” said Oskar Hansson, M.D., Ph.D.,
Professor of Neurology at Lund University and Skåne University
Hospital, Sweden, who led the oral late-breaker presentation at the
CTAD conference. “Having research from nearly two thousand patients
provides invaluable insights into the dynamics of the
interconnected pathologies within this complex disease.”
The two pathological hallmarks of Alzheimer’s disease—amyloid
beta plaque and neurofibrillary tangles (composed of abnormal
p-tau)—disrupt communication between neurons, which leads to the
loss of brain function, as well
as neurodegeneration and clinical decline, which can
begin in the early stages of Alzheimer’s disease.
Biogen also presented data from the Phase 3b redosing study,
EMBARK, which examined the impact of patients with Alzheimer’s
disease stopping ADUHELM treatment for an extended period of time
(average length of 1.7 years) before re-initiating treatment. The
study showed that reductions in amyloid beta plaque were maintained
in the high-dose group during the treatment gap period compared to
the placebo group. Although the disease continued to progress after
treatment discontinuation, numerical differences in favor of
ADUHELM were maintained across clinical endpoints.
The EMBARK baseline data underscore that further scientific
evidence is needed to better understand the impact of
discontinuation from anti-amyloid treatment and the role that other
underlying pathological processes may play in disease
progression.
EMBARK is not a randomized study and there may be selection bias
for the enrolling patients; Interpretation of these data must weigh
the potential influence of the heterogeneity of dose, duration of
exposure, and treatment gap periods across individuals in the
study. The analysis is from the largest clinical trial dataset
available in early Alzheimer’s disease, which included 1,856
screened patients from EMERGE, ENGAGE, PRIME and EVOLVE.
About
ADUHELM™ (aducanumab-avwa)
injection 100 mg/mL solutionADUHELM is indicated for the
treatment of Alzheimer’s disease. Treatment with ADUHELM should be
initiated in patients with mild cognitive impairment or mild
dementia stage of disease, the population in which treatment was
initiated in clinical trials. There are no safety or effectiveness
data on initiating treatment at earlier or later stages of the
disease than were studied. This indication is approved under
accelerated approval based on reduction in amyloid beta plaques
observed in patients treated with ADUHELM. Continued approval for
this indication may be contingent upon verification of clinical
benefit in confirmatory trial(s).
Aducanumab-avwa is a monoclonal antibody directed against
amyloid beta. The accumulation of amyloid beta plaques in the brain
is a defining pathophysiological feature of Alzheimer’s disease.
The accelerated approval of ADUHELM has been granted based on data
from clinical trials showing the effect of ADUHELM on reducing
amyloid beta plaques, a surrogate biomarker that is reasonably
likely to predict clinical benefit, in this case a reduction in
clinical decline.
ADUHELM can cause serious side effects including: Amyloid
Related Imaging Abnormalities or “ARIA”. ARIA is a common side
effect that does not usually cause any symptoms but can be serious.
Although most people do not have symptoms, some people may have
symptoms such as: headache, confusion, dizziness, vision changes
and nausea. The patient’s healthcare provider will do magnetic
resonance imaging (MRI) scans before and during treatment with
ADUHELM to check for ARIA. ADUHELM can also cause serious allergic
reactions. The most common side effects of ADUHELM include:
swelling in areas of the brain, with or without small spots of
bleeding in the brain or on the surface of the brain (ARIA);
headache; and fall. Patients should call their healthcare provider
for medical advice about side effects.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating
on the global co-development and co-promotion of aducanumab.
Please click here for full Prescribing Information,
including Medication Guide, for ADUHELM.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has the
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
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About Eisai Co., Ltd.Eisai Co., Ltd. is a
leading global pharmaceutical company headquartered in Japan.
Eisai’s corporate philosophy is based on the human health care
(hhc) concept, which is to give first thought to patients and
their families, and to increase the benefits that health care
provides to them. With a global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to
realize our hhc philosophy by delivering innovative
products to target diseases with high 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 a treatment for Alzheimer’s disease, Eisai aims to
establish the “Eisai Dementia Platform.” Through this platform,
Eisai plans to deliver novel benefits to those living with dementia
and their families through constructing a “Dementia Ecosystem,” by
collaborating with partners such as medical organizations,
diagnostic development companies, research organizations, and
bio-ventures in addition to private insurance agencies, finance
industries, fitness clubs, automobile makers, retailers, and care
facilities. For more information about Eisai Co., Ltd., please
visit https://www.eisai.com.
Biogen Safe Harbor
This news release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, about the
potential clinical effects of ADUHELM; the potential benefits,
safety and efficacy of ADUHELM; the treatment of Alzheimer’s
disease; results from the EMBARK study; the anticipated benefits
and potential of Biogen’s collaboration arrangements with Eisai;
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trials and do not ensure regulatory approval. You should not place
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CONTACTS:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.comEisai Inc. (U.S.
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