TOKYO, July 29, 2021 /PRNewswire/ -- Eisai Co., Ltd.
(Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") and Biogen
Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced
results of a longitudinal preliminary assessment of the clinical
effects of lecanemab (development code: BAN2401) — granted
Breakthrough Therapy designation by the U.S. Food and Drug
Administration (FDA) in June 2021 —
following 18 months of treatment in the open-label extension (OLE)
of the Phase 2b proof-of-concept
study in subjects with early Alzheimer's disease (AD) (Mild
Cognitive Impairment [MCI] due to AD and mild AD) at the
Alzheimer's Association International Conference (AAIC) held in
Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.:
57780).
Lecanemab Study 201 and OLE
Lecanemab is an
investigational humanized monoclonal antibody that preferentially
binds to soluble amyloid-beta (Aβ) aggregates (protofibrils).
Lecanemab reduced brain Aβ and slowed clinical decline in an
18-month Phase 2b proof of concept
study (Study 201, n=856) in early AD (Alz Res Therapy 13; 2021).
After analysis of the core study, there was an off-treatment gap
period of 9-59 months (period of time between the last dose of
lecanemab in the core and the OLE baseline; average of 24 months).
After this off-treatment gap, the OLE evaluating the 10 mg/kg IV
biweekly lecanemab dosing was implemented (n=180 from core study
enrolled). The clinical effect of treatment with lecanemab was
assessed via the adjusted mean change of the AD Composite Score
(ADCOMS), the primary clinical endpoint of the core study. The
ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score
indicating greater impairment. Additional clinical endpoints
included Clinical Dementia Rating-Sum of Boxes (CDR-SB) and AD
Assessment Scale – Cognitive Subscale (ADAS-Cog).
May suggest a potential disease-modifying effect
For
subjects with early AD at Study 201 OLE baseline, the
dose-dependent clinical treatment effect of lecanemab
administration relative to placebo during the core phase was
maintained. While off-treatment during the gap period, people who
received 10 mg/kg IV in the core continued to perform better than
those who received placebo on ADCOMS. While off-treatment during
the gap period, subjects declined at the same rate on key clinical
measures in all core treatment groups. The increase in adjusted
mean change between the three month follow up after the core
18-month and OLE baseline for lecanemab bi-weekly, lecanemab
monthly and placebo dosing respectively were 0.11 (0.07 to 0.18 ),
0.10 (0.12 to 0.22) and 0.09 (0.19 to 0.28) for ADCOMS. Similar
results were observed for CDR-SB and ADAS-Cog. This may suggest a
potential disease-modifying effect of lecanemab.
Potential relationship between the plasma Aβ42/40 ratio,
brain amyloid by PET and treatment
Low values of plasma
Aβ42/40 ratio is recognized as an indicator of elevated amyloid in
the brain, and was assessed in a subset of participants in Study
201.1 The plasma Aβ42/40 ratio increased during the core
phase and OLE in those treated with lecanemab and decreased during
the gap period, potentially demonstrating the relationship between
the plasma Aβ42/40 ratio and treatment with lecanemab. The
lecanemab treatment related increases in plasma Aβ42/40 ratio were
inversely correlated with treatment related reduction of brain
amyloid in the core and OLE (Poster No. 57760).
Assessing the long-term effect of continued treatment with
lecanemab
Study participants with early AD at the OLE
baseline who received placebo during the core phase and were
treated for the first time with lecanemab during OLE, as well as
those treated with lecanemab both during the core phase and during
OLE, showed reduced clinical decline relative to natural disease
progression (reference similar population from ADNI). The adjusted
mean change from OLE baseline at the end of the 18-month OLE study
period for core 10 mg/kg bi-weekly dosing, 10 mg/kg monthly dosing,
and placebo groups respectively were 0.102, 0.165 and 0.07 for
ADCOMS, all of which showed a slower rate of progression as
compared to ADNI (0.214). Similar results were observed for CDR-SB
and ADAS-Cog. The results support the concept of increased
long-term benefit of continued treatment with lecanemab when
initiated in the early AD stage.
These preliminary findings are based on limited data and are
being further evaluated in the ongoing Phase 3 Clarity AD study for
early AD.
"The findings from the lecanemab Phase 2b OLE study
are encouraging as they supply further insights into outcomes with
anti-amyloid therapies and we look forward to learning more in the
Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway,"
said Lynn Kramer, M.D., Chief
Clinical Officer, Neurology Business Group, Eisai. "The
unprecedented confluence of medical knowledge, data analytics, and
technological advances make it an incredibly exciting time for
Alzheimer's research. This combined with Eisai's precision research
approach, which is a treatment paradigm based on a person's
pathophysiological biomarker profile along the Alzheimer' disease
continuum, makes our company uniquely positioned to research and
develop new solutions for patients and their families."
Alfred Sandrock, Jr., M.D.,
Ph.D., Head of Research and Development at Biogen, said, "The
findings from the Open-Label Extension further strengthen our
belief in the potential of addressing amyloid beta pathology in
Alzheimer's disease. We look forward to our ongoing collaboration
with Eisai to study lecanemab and continuing to pioneer to address
the high unmet need for Alzheimer's disease patients."
The enrollment of 1,795 patients with early AD in the Phase 3
Clarity AD clinical study was completed in March 2021. The study's primary endpoint is
expected to be completed by the end of September 2022. The Phase 3 clinical study, AHEAD
3-45, is currently evaluating lecanemab in individuals with
preclinical AD.
The presentation video and slides are available on the
investors' section of the Eisai Co., Ltd. website.
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 news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, relating to the potential clinical
effects of lecanemab; the potential benefits, safety and efficacy
of lecanemab; the results of the OLE of the Phase 2b study of lecanemab; the clinical development
program, clinical trial(s) and data readouts and presentations for
lecanemab; potential regulatory discussions, submissions and
approvals and the timing thereof; the identification and treatment
of Alzheimer's disease; the potential of Biogen's commercial
business and pipeline programs, including lecanemab; the
anticipated benefits and potential of Biogen's collaboration
arrangements with Eisai; and risks and uncertainties associated
with drug development and commercialization. These forward-looking
statements may be accompanied by such words as "aim," "anticipate,"
"believe," "could," "estimate," "expect," "forecast," "goal,"
"intend," "may," "plan," "potential," "possible," "prospect,"
"will," "would" 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 unexpected concerns that may arise from
additional data, analysis or results obtained during clinical
trials; the occurrence of adverse safety events; risks of
unexpected costs or delays; the risk of other unexpected hurdles;
uncertainty of success in the development and potential
commercialization of lecanemab; regulatory submissions may take
longer or be more difficult to complete than expected; 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 lecanemab; actual timing and content of
submissions to and decisions made by the regulatory authorities
regarding lecanemab; 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; third party collaboration
risks; the direct and indirect impacts of the ongoing COVID-19
pandemic on Biogen's business, results of operations and financial
condition; and any other risks and uncertainties that are described
in other reports Biogen has filed with the U.S. Securities and
Exchange Commission. These statements are based on Biogen's current
beliefs and expectations and speak only as of the date of this news
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.
[Notes to editors]
About Lecanemab (BAN2401)
Lecanemab is an
investigational humanized monoclonal antibody for Alzheimer's
disease (AD) that is the result of a strategic research alliance
between Eisai and BioArctic. Lecanemab selectively binds to
neutralize and eliminate soluble, toxic amyloid-beta (Aβ)
aggregates that are thought to contribute to the neurodegenerative
process in AD. As such, lecanemab 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 lecanemab for the treatment of AD 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 lecanemab and the parties amended
that agreement in October 2017.
Currently, lecanemab is being studied in a pivotal Phase 3 clinical
study in symptomatic early AD (Clarity-AD), following the outcome
of the Phase 2 clinical study (Study 201). In July 2020, the Phase 3 clinical study (AHEAD
3-45) for individuals with preclinical AD, meaning they are
clinically normal and have intermediate or elevated levels of
amyloid in their brains, was initiated. AHEAD 3-45 is conducted as
a public-private partnership between the Alzheimer's Clinical Trial
Consortium, funded by the National Institute on Aging, part of the
National Institutes of Health, and Eisai.
About the Joint Development between Eisai and Biogen for
Alzheimer's Disease
Eisai and Biogen are collaborating on
the joint development and commercialization of AD treatments. Eisai
serves as the lead in the co-development of lecanemab and Biogen
serves as the lead in the co-development of aducanumab, an anti-Aβ
antibody.
About the Collaboration between Eisai and BioArctic for
Alzheimer's Disease
Since 2005, BioArctic has had a
long-term collaboration with Eisai regarding the development and
commercialization of drugs for the treatment of AD. The
commercialization agreement on the lecanemab antibody was signed in
December 2007, and the development
and commercialization agreement on the antibody lecanemab back-up
for AD was signed in May 2015. Eisai
is responsible for the clinical development, application for market
approval and commercialization of the products for AD. BioArctic
has no development costs for lecanemab in AD.
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.
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.
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 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, 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, commercializes biosimilars of advanced biologics and is
focused on advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer's disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
References
1 Pérez-Grijalba, V.,
Romero, J., Pesini, P. et al. Plasma Aβ42/40 Ratio Detects Early
Stages of Alzheimer's Disease and Correlates with CSF and
Neuroimaging Biomarkers in the AB255 Study. J Prev Alzheimers
Dis 6, 34–41 (2019). https://doi.org/10.14283/jpad.2018.41.
Contacts
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Eisai Co.,
Ltd.
Public Relations
Department
TEL:
+81-(0)3-3817-5120
Investor Relations
Department
TEL:
+81-(0)3-3817-5121
Eisai Inc,
+201-753-1945
Libby_Holman@eisai.com
|
Biogen
Inc.
Media
Contact:
Allison
Parks
+1
781-464-3260
public.affairs@biogen.com
Investor
Contact:
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Hencke
+1 781 464
2442
IR@biogen.com
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