Biogen and Eisai Report Data from Long-Term Extension Phase 1b
Study of Investigational Alzheimer’s Disease Treatment
Aducanumab
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo,
CEO: Haruo Naito, “Eisai”) announced results from a recent analysis
of the ongoing long-term extension (LTE) Phase 1b study of
aducanumab, an investigational treatment for mild cognitive
impairment (MCI) due to Alzheimer’s disease (AD) and mild AD
dementia. The updated analyses include data from the
placebo-controlled period and LTE for patients treated with
aducanumab up to 36 months in the titration cohort and up to 48
months in the fixed-dose cohorts. The results are generally
consistent with previous interim analyses, and there were no
changes to the risk-benefit profile of aducanumab.
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 AD or
mild AD dementia. 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 study 196 patients received
aducanumab or placebo, of which 143 patients entered the LTE.
The LTE cohorts were allocated across six dosing arms
including: placebo switchers, 1 mg/kg switchers to 3 mg/kg,
fixed doses (3 mg/kg, 6 mg/kg, 10 mg/kg) and titration.
Additionally, there were discontinuations as expected in studies of
36 or more months. As a result, there are small patient numbers in
the new analyses.
The results for each dose arm are generally consistent with
previous interim analyses. Amyloid plaque levels as measured by
positron emission tomography (PET) continued to decrease in a dose-
and time-dependent manner in patients from the titration cohort at
36 months and fixed-dose cohorts at 48 months. 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. Analyses of exploratory
clinical endpoints Clinical Dementia Rating Sum of Boxes (CDR-SB)
and the Mini-Mental State Examination (MMSE) suggest a continued
benefit on the rate of clinical decline over 36 months and 48
months, respectively. 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.
Of the 185 patients dosed with aducanumab in the Phase 1b study,
46 patients experienced amyloid 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 (MRI),
clinically asymptomatic and resolved or stabilized within 4-12
weeks, with most patients continuing treatment. In the Phase 1b
LTE, the most commonly reported adverse events were headache, fall
and ARIA.
Detailed results of the study will be presented at upcoming
medical conferences.
About AducanumabAducanumab (BIIB037) is an
investigational compound being studied for the treatment of early
Alzheimer’s disease. 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 collaboration and license
agreement. As of October 22, 2017, Biogen and Eisai Co. Ltd. are
collaborating on the development and commercialization of
aducanumab globally.
About the Joint Development Agreement between Biogen and
Eisai for Alzheimer’s DiseaseEisai and Biogen are widely
collaborating on the joint development and commercialization of
Alzheimer’s disease treatments. Biogen serves as the lead for
co-development of aducanumab, Biogen’s investigational anti-amyloid
beta (Aβ) antibody for patients with Alzheimer’s disease which
Eisai has been co-developing since October 22, 2017. Eisai
serves as the lead in the co-development of elenbecestat, a BACE
inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril
antibody, and the companies plan to pursue marketing authorizations
for the three compounds worldwide. If approved, the companies will
also co-promote the products in major markets, such as the United
States, the European Union and Japan.
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 Harbor This 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; 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.
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