Three- and four-year data continued to show
reduction in amyloid plaque and to suggest a slowing of the rate of
clinical decline in patients
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo,
CEO: Haruo Naito, “Eisai”) announced that Biogen presented results
at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in
Barcelona, Spain, from the recent 36- and 48-month analyses of the
ongoing long-term extension (LTE) of the Phase 1b study of
aducanumab, an investigational treatment for mild cognitive
impairment (MCI) due to Alzheimer’s disease (AD) and mild AD.
A late-breaking oral presentation and a poster
included data from patients treated with aducanumab for up to 36
and 48 months. Data from both analyses showed a reduction in
amyloid plaque levels in a dose- and time-dependent manner, as
measured by positron emission tomography (PET). In addition,
analyses of exploratory clinical endpoints, Clinical Dementia
Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination
(MMSE), suggested a continued slowing of clinical decline over 36
months and 48 months. The results in each dosing arm were generally
consistent with previously reported analyses of this study, and
there were no changes to the risk-benefit profile of
aducanumab.
“This Phase 1b study now has four years of
aducanumab results, and we are encouraged by these data, which
continued to show a reduction in amyloid plaque levels and suggest
our investigational therapy may slow clinical progression of the
disease,” said Alfred Sandrock, Jr., M.D., Ph.D., executive vice
president and chief medical officer at Biogen. “The Phase 3 studies
are now fully enrolled, and we remain driven by the profound unmet
needs of patients, families, caregivers and society.”
About the Phase 1b StudyThe
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 AD or mild AD dementia.
The primary endpoint for the study was safety. Other endpoints
(amyloid reduction, CDR-SB and MMSE) were exploratory.
The study included fixed dosing at 1, 3, 6 and 10 mg/kg as well
as an arm with a titration regimen up to 10 mg/kg in a cohort of
ApoE ε4 carriers only.
In the Phase 1b study, 196 patients received aducanumab or
placebo, of which 143 entered the LTE. All patients who continued
in the LTE were switched to, or continued on, aducanumab treatment.
The LTE cohorts were allocated across six dosing arms including:
placebo switchers (n=37), 1 mg/kg switchers to 3 mg/kg (n=19),
fixed doses (3 mg/kg [n=26], 6 mg/kg [n=24], 10 mg/kg [n=19]) and
titration (n=18). There were discontinuations, as expected in
studies of 36 or more months. As a result, there are smaller
patient numbers in the LTE over time.
Of the 185 patients dosed with aducanumab in the
Phase 1b study, 46 patients experienced amyloid-related imaging
abnormalities (ARIA)-E (edema). Eight patients experienced more
than one episode of ARIA-E. The majority of ARIA events occurred
early in the course of treatment; they were typically mild
radiographically, clinically asymptomatic and resolved or
stabilized within 4-12 weeks, with most patients continuing
treatment. In the Phase 1b study, the most commonly reported
adverse events were headache, fall and ARIA. There were no new
incident cases of ARIA-E since the last interim analysis.
36-Month DataAmyloid plaque levels were measured
by PET using the standardized uptake value ratio (SUVR), and
continued to decline in those who remained on treatment for 36
months. Amyloid plaque levels in the 10 mg/kg fixed dose at 36
months remained at a level considered below the quantitative
cut-point that discriminates between a positive and negative
scan.
The exploratory endpoints, CDR-SB and the MMSE,
measure cognitive and functional decline associated with AD. The
results of these assessments suggest a continued slowing of
clinical decline during the third year of treatment with aducanumab
in certain groups. Clinical effects with titrated aducanumab in the
second year of the LTE were generally consistent with findings in
the 10 mg/kg fixed-dose cohorts.
The expected average dose for the titration
cohort at 36 months was 8.4 mg/kg.
At 36 months, a reduction of amyloid plaque
(versus placebo) was observed in all fixed-dose and titration arms
in a dose- and time-dependent manner. The changes in amyloid
plaque, CDR-SB and MMSE are detailed below.
At 36 months from the start of the Phase 1b
study: |
Adjusted MeanChange
fromBaseline inAmyloid
PETSUVR* |
Adjusted MeanChange fromBaseline
inCDR-SB |
Adjusted MeanChange fromBaseline
inMMSE |
Placebo switchers to aducanumab |
-0.248 |
4.83 |
-6.75 |
Switchers from 1 to 3 mg/kg |
-0.198 |
6.21 |
-6.24 |
3 mg/kg treatment group |
-0.241 |
3.86 |
-4.98 |
6 mg/kg treatment group |
-0.278 |
4.50 |
-9.07 |
10 mg/kg treatment group |
-0.301 |
2.87 |
-4.23 |
Titration treatment group |
-0.308 |
3.10 |
-4.28 |
* Parameter: Amyloid PET composite ROI
SUVR measure (Reference Region = cerebellum) |
|
48-Month DataIn patients treated up to 48
months, amyloid plaque continued to decrease in a dose- and
time-dependent manner. Amyloid plaque levels in the 10 mg/kg
fixed-dose at 48 months remained at a level considered below the
quantitative cut-point that discriminates between a positive and
negative scan. The changes in amyloid plaque, CDR-SB and MMSE are
detailed below.
At 48 months from the start of the Phase 1b
study: |
Adjusted MeanChange fromBaseline
inAmyloid PETSUVR* |
Adjusted MeanChange fromBaseline
inCDR-SB |
Adjusted MeanChange fromBaseline
inMMSE |
Placebo switchers to aducanumab |
-0.260 |
6.95 |
-10.24 |
Switchers from 1 to 3 mg/kg |
-0.232 |
8.44 |
-9.49 |
3 mg/kg treatment group |
-0.261 |
5.57 |
-8.22 |
6 mg/kg treatment group |
-0.324 |
7.75 |
-12.62 |
10 mg/kg treatment group |
-0.340 |
3.87 |
-4.82 |
* Parameter: Amyloid PET composite ROI
SUVR measure (Reference Region = cerebellum) |
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Phase 3 StudiesIn July 2018, enrollment was
completed for the Phase 3 aducanumab ENGAGE and EMERGE studies,
designed to evaluate the efficacy and safety of aducanumab in
slowing cognitive and functional impairment in people with early
Alzheimer’s disease.
About AducanumabAducanumab
(BIIB037) is an investigational compound being studied for the
treatment of early Alzheimer’s disease. Biogen licensed aducanumab
from Neurimmune under a collaboration and license agreement.
Aducanumab is a human 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). As of October 2017, Biogen and Eisai Co., Ltd. are
collaborating on the development and commercialization of
aducanumab globally.
About BiogenAt Biogen, our
mission is clear: we are pioneers in neuroscience. Biogen
discovers, develops and delivers worldwide innovative therapies for
people living with serious neurological and neurodegenerative
diseases. One of the world’s first global biotechnology companies,
Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller,
Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip
Sharp, and today has the leading portfolio of medicines to treat
multiple sclerosis, has introduced the first and only approved
treatment for spinal muscular atrophy and is focused on advancing
neuroscience research programs in Alzheimer’s disease and dementia,
multiple sclerosis and neuroimmunology, movement disorders,
neuromuscular disorders, pain, ophthalmology, neuropsychiatry and
acute neurology. Biogen also manufactures and commercializes
biosimilars of advanced biologics.
We routinely post information that may be
important to investors on our website at www.biogen.com. To learn
more, please visit www.biogen.com and follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
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 https://www.eisai.com.
Biogen Safe HarborThis press
release contains forward-looking statements, including statements
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 about additional results
from the Phase 1b study of aducanumab; the potential clinical
effects of aducanumab; the potential benefits, safety and efficacy
of aducanumab; the treatment of AD; and risks and uncertainties
associated with drug development and commercialization. These
forward-looking statements may be accompanied by words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “intend,” “may,” “plan,” “potential,” “possible,”
“will” and other words and terms of similar meaning. Drug
development and commercialization involve a high degree of risk,
and only a small number of research and development programs result
in commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements
or the scientific data presented.
These statements involve risks and uncertainties
that could cause actual results to differ materially from those
reflected in such statements, including without limitation,
unexpected concerns that may arise from additional data, analysis
or results obtained during clinical trials; regulatory authorities
may require additional information or further studies, or may fail
or refuse to approve or may delay approval of Biogen’s drug
candidates, including aducanumab; the occurrence of adverse safety
events; risks of unexpected costs or delays; the risks of other
unexpected hurdles; uncertainty of success in the development and
potential commercialization of aducanumab; failure to protect and
enforce Biogen’s data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property claims
and challenges; product liability claims; and third party
collaboration risks. The foregoing sets forth many, but not all, of
the factors that could cause actual results to differ from Biogen’s
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in Biogen’s most recent annual or quarterly report and
in other reports Biogen has filed with the Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this press
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
|
Contacts |
MEDIA CONTACT:Biogen Inc.David
Caouette+1-617-679-4945public.affairs@biogen.com |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations
DepartmentTEL: +81-(0)3-3817-5120Eisai Inc.Public Relations
DepartmentTEL: +1-551-262-2686 |
|
|
INVESTOR CONTACT:Biogen Inc.Matt
Calistri+1-781-464-2442IR@biogen.com |
INVESTOR CONTACT:Eisai Co., Ltd.Investor
Relations DepartmentTEL: +81-(0)3-3817-5327 |
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