TOKYO and CAMBRIDGE,
Mass., Aug. 3, 2022 /PRNewswire/ -- Eisai Co.,
Ltd. (Headquarters: Tokyo, CEO:
Haruo Naito, "Eisai") and Biogen
Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced that Eisai
presented new findings on a subcutaneous formulation of lecanemab
(BAN2401) and the modeling simulation of the impact of ApoE4
genotype on the incidence of amyloid-related imaging abnormalities
– edema/effusion (ARIA-E) – in subjects treated with lecanemab, an
investigational anti-amyloid beta (Aβ) protofibril antibody for the
treatment of mild cognitive impairment (MCI) due to Alzheimer's
disease (AD) and mild AD (collectively known as early AD) with
confirmed presence of amyloid pathology in the brain. The data were
shared at the Alzheimer's Association International Conference
(AAIC) in San Diego, CA.
Key Eisai presentations include:
Eisai Abstract #69438: Absolute Bioavailability of a
Single, Fixed Subcutaneous Dose of Lecanemab in Healthy
Subjects
This Phase 1 study was an open-label,
parallel-group study conducted in healthy subjects: 30 subjects
were randomized into a 10 mg/kg intravenous (IV) dose group and 29
subjects (5 of which were Japanese) were randomized into a
single fixed 700mg SC dose group. The absolute bioavailability of
lecanemab following a single SC injection was 49.7% (90% CI: 43.54
– 56.83). After SC dosing, the Cmax was observed 72 hours post-dose
and was 4-fold lower compared to IV infusion, which reflects the
relatively long absorption phase following SC dose administration
compared with 1-hour IV infusion. Lecanemab's half-life (~7 days)
was similar following SC and IV administrations. The incidence of
adverse events was similar between SC and IV administrations. No
positive results for neutralizing antibodies (NAb) were recorded in
this study. Lecanemab PK for the 5 Japanese subjects was similar to
that of the non-Japanese subjects following a single subcutaneous
dose administration.
Eisai Abstract #69429: Subcutaneous Dose Selection of
Lecanemab for Treatment of Subjects with Early Alzheimer's
Disease
In this analysis, modeling and simulation was
conducted to evaluate the equivalence of a fixed weekly SC dose to
a body weight-based 10 mg/kg IV bi-weekly dose with regard to
lecanemab exposure. The analysis showed that a fixed lecanemab SC
dose of 720 mg administered weekly may potentially result in
comparable exposure (AUC) and efficacy as measured by reduction in
amyloid PET SUVr to 10mg/kg IV dose administered bi-weekly. The
exposure-response model is based on the established correlation
between ARIA-E and Cmax. SC lecanemab dose is predicted to have a
lower incidence of ARIA-E compared to IV lecanemab due to lower
Cmax following SC administration.
Eisai Virtual Developing Topics Presentation Abstract #69402
/ Session VDT-4-29: Modeled Impact of ApoE4 Genotype on ARIA-E
Incidence in Patients Treated with Lecanemab
In this analysis, the results of the Phase 2
(Study 201) core study were used to explore the effect of ApoE4
genotype on ARIA-E incidence by modeling and simulation. The model
predictions were compared to the ARIA-E incidence observed in
subjects newly initiated on lecanemab 10 mg/kg bi-weekly in the
Phase 2 (Study 201) open-label long-term study (OLE
study). The effect of the ApoE4 genotype was analyzed in the
exposure-ARIA-E model with three categorical covariates (homozygous
carriers, heterozygous carriers, and noncarriers) using the results
of the Phase 2 (Study 201) core study. ApoE4 genotype
(homozygous) was a significant covariate in the exposure-ARIA-E
model, and the incidence of ARIA-E correlated best with Cmax at
steady state. On the other hand, there was no statistically
significant difference in ARIA-E incidence between ApoE4
noncarriers and heterozygous carriers. The predicted incidence of
ARIA-E when lecanemab was dosed at 10 mg/kg bi-weekly was 22.5% in
ApoE4 homozygous carriers, 6.8% in heterozygous carriers, and 5.4%
in ApoE4 noncarriers. In the OLE study, the incidence of ARIA-E
observed in ApoE4 homozygotes newly initiated on lecanemab 10 mg/kg
bi-weekly treatment was 25% (1 out of 4), comparable to the model
prediction of 22.5%. Amyloid-related imaging abnormalities (ARIA)
are an adverse event associated with amyloid-lowering therapies,
and it is important to monitor for and manage during treatment.
"In an effort to simplify the patient journey and fulfill our
human health care mission, Eisai is developing a
subcutaneous formulation of lecanemab that patients may be able to
use at home," said Michael Irizarry,
M.D., Senior Vice President, Deputy Chief Clinical Officer,
Alzheimer's Disease and Brain Health, Eisai Inc. "The new data
Eisai presented today about the bioavailability of subcutaneous
dosing, and comparability with intravenous dosing, was used by
Eisai to define the appropriate subcutaneous dosing that is
currently being tested in the Phase 3 Clarity AD open-label
extension. In addition, Eisai has expanded on the previous modeling
that explored the effect of the ApoE4 genotype on ARIA-E to further
our understanding of patient populations who are most impacted by
ARIA-E in the lecanemab clinical trials. The modeling will be
updated with data from Eisai's Phase 3 Clarity AD confirmatory
study reading out in fall 2022."
"We will continue to inform the treatment of patients with
Alzheimer's disease and further our development of new therapies,"
said Dominic Walsh, Head of
Neurodegenerative Research Unit at Biogen. "Subcutaneous
administration may provide a convenient option for patients and
their caregivers in the future, and we look forward to a continued
co-development with Eisai on this formulation."
On July 5, 2022, Eisai announced
the U.S. Food and Drug Administration (FDA) accepted the Biologics
License Application (BLA) for lecanemab under the accelerated
approval pathway and was granted priority review, with a
Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023. The readout of the primary
endpoint data of Clarity AD will occur in the fall of 2022. The FDA
has agreed that the results of Clarity AD when completed, can serve
as the confirmatory study to verify the clinical benefit of
lecanemab.
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 such an
investigational agent will successfully complete clinical
development or gain health authority approval.
Contacts
|
MEDIA
CONTACT:
Eisai Co.,
Ltd.
Public Relations
Department
TEL:
+81-(0)3-3817-5120
Eisai Inc.
(U.S.)
Libby Holman
+
1-201-753-1945
Libby_Holman@eisai.com
INVESTOR
CONTACT:
Eisai Co.,
Ltd.
Investor Relations
Department
TEL:
+81-(0)70-8688-9685
|
MEDIA
CONTACT:
Biogen Inc.
Ashleigh
Koss
+
1-908-205-2572
public.affairs@biogen.com
INVESTOR
CONTACT:
Biogen Inc.
Mike Hencke
+
1-781-464-2442
IR@biogen.com
|
[Notes to editors]
1. 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 (protofibrils) 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. Currently, lecanemab is being developed as
the only anti- Aβ antibody that can be used for the treatment of
early AD without the need for titration. With regard to the results
from pre-specified analysis at 18 months of treatment, Study 201
demonstrated reduction of brain Aβ accumulation
(P<0.0001) and slowing of disease progression
measured by ADCOMS* (P<0.05) in early
AD subjects. The study did not achieve its primary outcome
measure** at 12 months of treatment. The Study 201 open-label
extension was initiated after completion of the Core period and a
Gap period off treatment of 9-59 months (average of 24
months, n=180 from core study enrolled) to evaluate
safety and efficacy is underway.
Currently, lecanemab is being studied in a confirmatory Phase 3
clinical study in symptomatic early AD (Clarity-AD), following the
outcome of the Phase 2 clinical study (Study 201). Since
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, is ongoing. AHEAD 3-45 is conducted as a
public-private partnership between the Alzheimer's Clinical Trial
Consortium that provides the infrastructure for academic clinical
trials in Alzheimer's Disease and related dementias in the U.S,
funded by the National Institute on Aging, part of the National
Institutes of Health, Eisai and Biogen. Furthermore, Eisai has
initiated a lecanemab subcutaneous dosing Phase 1 study.
* Developed by Eisai, ADCOMS (AD
Composite Score) combines items from the ADAS-Cog (Alzheimer's
Disease Assessment Scale-cognitive subscale),
CDR (Clinical Dementia Rating) 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. The ADCOMS scale ranges from a
score of 0.00 to 1.97, with higher score indicating greater
impairment.
** An 80% or higher estimated
probability of demonstrating 25% or greater slowing in clinical
decline at 12 months treatment measured by ADCOMS from
baseline compared to placebo.
2. About the Collaboration between Eisai and
Biogen for Alzheimer's Disease
Eisai and Biogen
have been collaborating on the joint development and
commercialization of AD treatments since 2014. Eisai
serves as the lead of lecanemab development and
regulatory submissions globally with both companies
co-commercializing and co-promoting the product and Eisai
having final decision-making authority.
3. About the Collaboration between Eisai and
BioArctic for Alzheimer's Disease
Since 2005,
Eisai and BioArctic have had a long-term
collaboration regarding the development and commercialization of AD
treatments. 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. The
development and commercialization agreement on the antibody
lecanemab back-up was signed in May
2015.
4. About Eisai Co., Ltd.
Eisai's
Corporate Concept is "to give first thought to patients
and people in the daily living domain, and to increase the benefits
that health care provides." Under this Concept (also known
as human health care (hhc)
Concept), we aim to effectively achieve social good in the form of
relieving anxiety over health and reducing health disparities. With
a global network of R&D facilities, manufacturing sites and
marketing subsidiaries, we strive to create and deliver innovative
products to target diseases with high unmet medical needs, with a
particular focus in our strategic areas of Neurology and
Oncology.
In addition, we demonstrate our commitment to the elimination of
neglected tropical diseases (NTDs), which is a target (3.3) of the
United Nations Sustainable Development Goals (SDGs), with working
on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com
(for global headquarters: Eisai Co., Ltd.), and connect with us on
Twitter @Eisai_SDGs.
5. About Eisai Inc.
At Eisai
Inc., human health care
(hhc) is our mission and is the shared
purpose that connects us to those we serve creating a network of
powerful relationships that enables us to identify, understand and
work to address the needs of people throughout their lives. We
boldly push past the boundaries of science and aim to deliver
life-changing therapies and health-related solutions that matter to
people and society. We bring together science, technology and
real-world expertise to pursue a world free from cancer,
Alzheimer's disease and other neurodegenerative
diseases.
Everything we do is guided by the simple principle that patients
and their families come first, and we have a responsibility to
listen to and learn from them.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. The company's
presence in the U.S. includes three discovery centers as well as
commercial, clinical development and global demand organizations.
To learn more about Eisai, please visit us at www.eisai.com/US and
follow us on Twitter and LinkedIn. For more information on our work
in neurology, please visit the Eisai U.S. Neurology LinkedIn
page.
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.
6. About Biogen
As pioneers in
neuroscience, Biogen discovers, develops, and delivers
worldwide innovative therapies for people living with serious
neurological 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, Sir Kenneth
Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer's disease. Biogen
is also commercializing biosimilars and focusing on advancing
one of the industry's most diversified pipelines in neuroscience
that will transform the standard of care for patients in several
areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply
interrelated issues of climate, health, and equity. Healthy
Climate, Healthy Lives™ aims to eliminate fossil fuels across the
company's operations, build collaborations with renowned
institutions to advance the science to improve human health
outcomes, and support underserved communities.
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.
Biogen Safe Harbor
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, about the potential clinical effects of
lecanemab; the potential benefits, safety and efficacy
of lecanemab; potential regulatory discussions,
submissions and approvals and the timing thereof; the expected data
readout for the Clarity AD study; the treatment of Alzheimer's
disease; the anticipated benefits and potential of Biogen's
collaboration arrangements with Eisai; the
potential of Biogen's commercial business and pipeline
programs, including lecanemab; and risks and
uncertainties associated with drug development and
commercialization. These statements may be identified by words such
as "aim," "anticipate," "believe," "could," "estimate," "expect,"
"forecast," "intend," "may," "plan," "possible," "potential,"
"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
studies may not be indicative of full results or results from later
stage or larger scale clinical studies 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 studies, including the Clarity AD clinical trial
and AHEAD 3-45 study; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
hurdles; 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; uncertainty of success in the development and
potential commercialization of 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; and the direct and indirect impacts of the ongoing COVID-19
pandemic on Biogen's business, results of operations and financial
condition. 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 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/eisai-presents-new-findings-on-lecanemabs-investigational-subcutaneous-formulation-and-modeling-simulation-of-apoe4-genotype-on-aria-e-incidence-at-the-alzheimers-association-international-conference-aaic-2022-301599304.html
SOURCE Eisai Inc.