Eisai and Biogen Announce Positive Topline Results
of the Final Analysis for BAN2401 at 18 Months
- The final analysis at 18 months
of the 856 patient Phase II clinical study in early Alzheimer's
disease demonstrated statistically significant slowing in clinical
decline and reduction of amyloid beta accumulated in the
brain
- First late-stage study data
successfully demonstrating potential disease-modifying effects on
both clinical function and amyloid beta accumulation in the
brain
- New data provide compelling
evidence to further support amyloid hypothesis as a therapeutic
target for Alzheimer's disease
TOKYO and CAMBRIDGE, Mass.,
July 05, 2018 (GLOBE NEWSWIRE) -- Eisai Co., Ltd.
(Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc.
(NASDAQ:BIIB) (Headquarters: Cambridge, Massachusetts, United
States, CEO: Michel Vounatsos, "Biogen") announced positive topline
results from the Phase II study with BAN2401, an anti-amyloid beta
protofibril antibody, in 856 patients with early Alzheimer's
disease. The study achieved statistical significance on key
predefined endpoints evaluating efficacy at 18 months on slowing
progression in Alzheimer's Disease Composite Score (ADCOMS) and on
reduction of amyloid accumulated in the brain as measured using
amyloid-PET (positron emission tomography).
Study 201 (ClinicalTrials.gov
identifier NCT01767311) is a placebo-controlled, double-blind,
parallel-group, randomized study in 856 patients with mild
cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild
Alzheimer's dementia (collectively known as early Alzheimer's
disease) with confirmed amyloid pathology in the brain. Efficacy
was evaluated at 18 months by predefined conventional statistics on
ADCOMS, which combines items from the Alzheimer's Disease
Assessment Scale-cognitive subscale (ADAS-Cog), the Clinical
Dementia Rating Sum of Boxes (CDR-SB) scale and the Mini-Mental
State Examination (MMSE) to enable sensitive detection of changes
in early AD symptoms. Patients were randomized to five dose
regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10
mg/kg monthly and 10 mg/kg biweekly, or placebo.
Topline results of the final
analysis of the study demonstrated a statistically significant
slowing of disease progression on the key clinical endpoint
(ADCOMS) after 18 months of treatment in patients receiving the
highest treatment dose (10 mg/kg biweekly) as compared to placebo.
Results of amyloid PET analyses at 18 months, including reduction
in amyloid PET standardized uptake value ratio (SUVR) and amyloid
PET image visual read of subjects converting from positive to
negative for amyloid in the brain, were also statistically
significant at this dose. Dose-dependent changes from baseline were
observed across the PET results and the clinical endpoints.
Further, the highest treatment dose of BAN2401 began to show
statistically significant clinical benefit as measured by ADCOMS as
early as 6 months including at 12 months.
BAN2401 demonstrated an acceptable
tolerability profile through 18 months of study drug
administration. The most common treatment emergent adverse events
were infusion-related reactions and Amyloid Related Imaging
Abnormalities (ARIA). Infusion related reactions were mostly mild
to moderate in severity. Incidence of ARIA-E (edema) was not more
than 10% in any of the treatment arms, and less than 15% in
patients with APOE4 at the highest dose per the study protocol
safety and reporting procedures.
Detailed results of the study will
be presented at future academic conferences.
"The 18-month results of the
BAN2401 trial are impressive and provide important support for the
amyloid hypothesis," said Jeff Cummings, M.D., founding director,
Cleveland Clinic Lou Ruvo Center for Brain Health. "I look forward
to seeing the full data set shared with the broader Alzheimer's
community as we advance against this devastating disease."
"This is the first late-stage
anti-amyloid antibody study to successfully achieve statistically
significant results at 18 months, further validating the amyloid
hypothesis," said Lynn Kramer, M.D., Chief Clinical Officer and
Chief Medical Officer, Neurology Business Group, Eisai. "We will
discuss these very encouraging results with regulatory authorities
to determine the best path forward. We continue to work towards the
goal of delivering BAN2401 to patients and healthcare professionals
as early as possible."
"The prospect of being able to
offer meaningful disease-modifying therapies to individuals
suffering from this terrible disease is both exciting and
humbling," said Alfred Sandrock, M.D., Ph.D., executive vice
president and chief medical officer at Biogen. "These BAN2401
18-month data offer important insights in the investigation of
potential treatment options for patients with Alzheimer's disease
and underscores that neurodegenerative diseases may not be as
intractable as they once seemed."
As reported in December 2017, the
study did not achieve its primary outcome measure which was
designed to enable a potentially more rapid entry into Phase III
development based on Bayesian analysis at 12 months of treatment.
Upon the final analysis at 18 months using predefined conventional
statistical method, the study did demonstrate a statistically
significant slowing of disease progression on the key clinical
endpoint (ADCOMS) after 12 months of treatment in patients
receiving the highest treatment dose (10 mg/kg biweekly) as
compared to placebo.
This release discusses
investigational uses of an agent in development and is not intended
to convey conclusions about efficacy or safety. There is no
guarantee that any investigational uses of such product will
successfully complete clinical development or gain health authority
approval.
Biogen Safe
Harbor Statement
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 results from
the Phase 2 study of BAN2401, the potential clinical effects of
BAN2401, risks and uncertainties associated with drug development
and commercialization, the potential benefits, safety and efficacy
of BAN2401, and therapies for other neurological diseases, the
timing and status of current and future regulatory filings, the
anticipated benefits and potential of Biogen's collaboration
arrangements with Eisai and the potential of Biogen's commercial
business and pipeline programs, including BAN2401, elenbecestat and
aducanumab. 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 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 BAN2401,
elenbecestat and/or 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 BAN2401, elenbecestat and/or
aducanumab, which may be impacted by, among other things,
unexpected concerns that may arise from additional data or
analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce Biogen's data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; uncertainty as to whether the
anticipated benefits and potential of Biogen's collaboration
arrangement with Eisai can be achieved; 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.
Media Inquiries |
Eisai
Co., Ltd.
Public Relations Department
TEL: +81-(0)3-3817-5120
Eisai Inc.
Public Relations Department
TEL: +1-201-746-2139 |
Biogen
Inc.
Public Affairs
TEL: +1-781-464-3260
public.affairs@biogen.com |
<Notes to editors>
1. About
BAN2401
BAN2401 is a humanized monoclonal antibody for Alzheimer's disease
that is the result of a strategic research alliance between Eisai
and BioArctic. BAN2401 selectively binds to neutralize and
eliminate soluble, toxic Abeta aggregates that are thought to
contribute to the neurodegenerative process in Alzheimer's disease.
As such, BAN2401 may have the potential to have an effect on
disease pathology and to slow down the progression of the disease.
Eisai obtained the global rights to study, develop, manufacture and
market BAN2401 for the treatment of Alzheimer's disease pursuant to
an agreement concluded with BioArctic in December 2007. In March
2014, Eisai and Biogen entered into a joint development and
commercialization agreement for BAN2401 and the parties amended
that agreement in October 2017.
2. About
ADCOMS
Developed by Eisai, ADCOMS (AD Composite Score) combines items from
the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive
subscale), CDR-SB (Clinical Dementia Rating Sum of Boxes) and the
MMSE (Mini-Mental State Examination) scales to enable a sensitive
detection of changes in clinical functions of early AD symptoms and
changes in memory. This Study 201 utilizes ADCOMS as its key
endpoint for assessing clinical symptoms.
3. About Amyloid
PET Imaging
Amyloid PET (Positron Emission Tomography) imaging is a diagnostic
method that enables the visualization of amyloid plaque present in
the brain as well as the quantitative evaluation of amyloid plaque
distribution and accumulation in the brain via administration of a
minute amount of PET tracer, which specifically binds to amyloid
plaque and marks it with positron. Amyloid PET imaging enables the
assessment of pathology change and assistance of diagnosis of
patients with Alzheimer's-disease including MCI, and estimates the
clinical effect of disease modifiers based on the amyloid
hypothesis.
4. About the
Joint Development Agreement between Eisai and Biogen for
Alzheimer's Disease
Eisai and Biogen are widely collaborating on the joint development
and commercialization of Alzheimer's disease treatments. Eisai
serves as the lead in the co-development of elenbecestat, a BACE
inhibitor, and BAN2401, an anti-amyloid beta (Abeta) protofibril
antibody, while Biogen serves as the lead for co-development of
aducanumab, Biogen's investigational anti-amyloid beta (Abeta)
antibody for patients with Alzheimer's disease, 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.
As to BAN2401 and elenbecestat,
both companies will equally split overall costs, including research
and development expenses. Eisai will book all sales for
elenbecestat and BAN2401 following marketing approval and launch,
and profits will be equally shared between the companies.
5. 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 www.eisai.com.
6. About
Biogen
At 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
Weissman, 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, neuroimmunology, movement
disorders, neuromuscular disorders, pain, ophthalmology,
neuropsychiatry, and acute neurology. Biogen also manufactures and
commercializes biosimilars of advanced biologics.
Biogen routinely posts information
that may be important to investors on its website at
www.biogen.com. To learn more, please visit www.biogen.com and
follow Biogen on social media - Twitter, LinkedIn, Facebook,
Youtube.
7. About
BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company
focusing on disease modifying treatments and reliable biomarkers
and diagnostics for neurodegenerative diseases, such as Alzheimer's
disease and Parkinson's disease. The company also develops a
potential treatment for Complete Spinal Cord Injury. BioArctic
focuses on innovative treatments in areas with high unmet medical
needs. The company was founded in 2003 based on innovative research
from Uppsala University, Sweden. Collaborations with universities
are of great importance to the company together with our
strategically important global partners in the Alzheimer (Eisai)
and Parkinson (AbbVie) projects. The project portfolio is a
combination of fully funded projects run in partnership with global
pharmaceutical companies and innovative in-house projects with
significant market- and out-licensing potential. BioArctic's
B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B).
www.bioarctic.com.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Biogen Inc. via Globenewswire
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Biogen (NASDAQ:BIIB)
Historical Stock Chart
From Apr 2023 to Apr 2024