STOCKHOLM, July 18, 2019 /PRNewswire/ -- BioArctic AB (publ)
(Nasdaq Stockholm: BIOA B) announces that new data related to
BAN2401 were presented on July 17.
The presentations were held by BioArctic and its partner, Eisai, at
the Alzheimer's Association International Conference® 2019 (AAIC®)
in Los Angeles, USA. BAN2401 was designed and generated to
selectively target toxic protofibrils and oligomers, soluble
aggregated forms of amyloid beta. The new data included details of
the binding profile of BAN2401 and additional analyses from the
earlier presented Phase 2b study in
856 patients with early Alzheimer's disease. All data were
consistent with previously presented outcomes from the Phase
2b study.
BioArctic presented new data around BAN2401's binding profile.
The new data confirmed BAN2401's strong binding and high
selectivity for protofibrils and oligomers. The poster presentation
can be found on BioArctic's website at www.bioarctic.com.
Eisai presented data on biomarkers of neurodegeneration
(cerebral spinal fluid, or CSF, biomarkers), which suggested that
treatment with BAN2401 in patients with early Alzheimer's disease
was associated with reduced neurodegeneration at both 12- and
18-months timepoints. CSF biomarker data shows the impact
downstream of the amyloid cascade, including a reduction of tau
pathology (p-tau) and synaptic function (neurogranin), and a
reduction in the increase of axonal degeneration (neurofilament
light chain or NfL). These analyses were conducted with a subset of
patients from the Phase 2b study
where cerebral spinal fluid samples were collected. The findings
are consistent with the previously presented positive effects on
cognition and on reduction of amyloid beta in the brain with PET
imaging.
Further, it was observed that the positive impact on
neurodegenerative biomarkers was more pronounced in patients who
are ApoE4 carriers. This finding is also is consistent with the
previously announced results for ApoE4 carriers on cognition and
reduction of amyloid beta in the brain with BAN2401.
Eisai also presented new data that showed a positive correlation
between clinical cognition endpoints and reduction of amyloid beta
in the brain after both 12- and 18-months treatment. The analysis
was conducted comparing the clinical endpoints ADCOMS, ADAS-Cog and
CDR-SB with two approaches to analyze the reduction of amyloid beta
in the brain with PET imaging. The subset of patients included in
this analysis had assessments from both from the clinical endpoints
and PET imaging in the Phase 2b study
in early Alzheimer's disease.
Further, increased BAN2401 exposure measured by serum
concentrations correlated with larger reductions of amyloid beta in
the brain measured by PET.
"The data presented today further demonstrate the uniqueness of
BAN2401 and the robustness of the positive Phase 2b data previously presented. We look forward to
Eisai´s progression of the confirmatory Phase 3 study in patients
with early Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic.
BAN2401 is being studied by BioArctic's partner Eisai in a Phase
3 study in patients with early Alzheimer's disease to confirm the
previously announced Phase 2b study
results.
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.
For more information, please contact:
Gunilla Osswald, PhD, CEO,
BioArctic AB
E-mail: gunilla.osswald@bioarctic.se
Telephone:
+46-8-695-69-30
This information was submitted for publication at
7:00 a.m. CET on July 18, 2019.
Notes to editors
About BAN2401
BAN2401 is a humanized monoclonal antibody that is the result of
a strategic research alliance between BioArctic and Eisai. BAN2401
has a unique binding profile and selectively binds to and
eliminates soluble, toxic amyloid beta aggregates (protofibrils and
oligomers) that are thought to contribute to the neurodegenerative
process in Alzheimer's disease. As such, BAN2401 has the potential
to have an effect on the 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. Currently, a global confirmatory Phase 3 clinical study
(Clarity AD) of BAN2401 in patients with early Alzheimer´s disease
is underway. According to Eisai, the final readout of the primary
endpoint of the study is targeted for 2022.
About the collaboration between BioArctic and
Eisai
Since 2005, BioArctic has long-term collaboration with Eisai
regarding the development and commercialization of drugs for the
treatment of Alzheimer's disease. The most important agreements are
the development and commercialization agreement on the BAN2401
antibody, which was signed in December
2007, and the development and commercialization agreement on
the antibody BAN2401 back-up for Alzheimer's disease, which was
signed in May 2015. Eisai is
responsible for the clinical development, application for market
approval and commercialization of the products for Alzheimer's
disease. BioArctic has no development costs for BAN2401 in
Alzheimer's disease.
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
its 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 (ticker: BIOA B). For
more information about BioArctic, please visit
www.bioarctic.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and
development-based pharmaceutical company headquartered in
Japan. Eisai defines their
corporate mission as "giving first thought to patients and their
families and to increasing the benefits health care provides,"
which Eisai calls their human health care (hhc)
philosophy. With approximately 10,000 employees working across the
global network of R&D facilities, manufacturing sites and
marketing subsidiaries, Eisai strives to realize their hhc
philosophy by delivering innovative products to address unmet
medical needs, with a particular focus in the strategic areas of
Neurology and Oncology.
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.
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