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 DepartmentTEL: +81-(0)3-3817-5120
Eisai Inc.Public Relations DepartmentTEL: +1-201-746-2139 |
Biogen Inc.Public AffairsTEL: +1-781-464-3260
public.affairs@biogen.com |
<Notes to editors>
1. About BAN2401BAN2401 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 Aβ 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 ADCOMSDeveloped 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
ImagingAmyloid 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 DiseaseEisai 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 (Aβ) protofibril
antibody, while Biogen serves as the lead for co-development of
aducanumab, Biogen’s investigational anti-amyloid beta (Aβ)
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 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 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 ABBioArctic
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.
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