Stockholm, Sweden, December 2, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that presentations related to BAN2401 will be given at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) conference to be held December 4-7 in San Diego, California, USA.
Data regarding amyloid levels at the beginning of the open label extension phase of the Phase 2b study (Study 201) in patients with early Alzheimer’s disease will be presented by Eisai. Professor Lars Lannfelt, Uppsala University and BioArctic, will present binding profiles of BAN2401 and aducanumab to different forms of amyloid-beta. In addition, the study design and current status of the ongoing Phase 3 study, Clarity AD (Study 301), will be presented by Eisai.
Presentations related to BAN2401 during CTAD:
|Presentation ID||Topic||Date and Time
(Pacific Daylight Time)
|Session No. LB10
Late-breaking oral presentation
|Persistence of BAN2401-Mediated Amyloid Reductions Post-Treatment: A Preliminary Comparison of Amyloid Status Between the Core Phase of BAN2401-G000-201 and Baseline of the Open-Label Extension Phase in Subjects with Early Alzheimer’s Disease||Thursday, December 5
11:15 – 11:30 AM
|Session No. OC29
|Binding Profiles of BAN2401 and Aducanumab to Different Amyloid-Beta Species
Presenter: Prof. Lars Lannfelt, Uppsala University and BioArctic
|Saturday, December 7
11:30 – 11:45 AM
|Poster No P179
|BAN2401 in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study with an Open-Label Extension Phase to Confirm Safety and Efficacy (Clarity AD)||Friday, December 6 and Saturday, December 7|
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.
This information was submitted for publication at 8:00 a.m. CET on December 2, 2019.
Notes to editors
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) 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 (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. 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.
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.