Latest lecanemab data to be presented at the AD/PD™ congress

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Stockholm, March 5, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company and its collaboration partner Eisai will both present data relating to its investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401), at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, AD/PD™ 2021.

The International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders – which due to the ongoing COVID-19 pandemic will be held online – is a key scientific event with a focus on improving the treatment of Alzheimer’s, Parkinson’s and other related neurodegenerative diseases.

BioArctic’s poster presentation will focus on findings in a recent study of brain tissue samples and lecanemab which, together with the previously announced promising data from the large phase 2b study of lecanemab in early Alzheimer’s disease, suggest that lecanemab could be of potential benefit for people with Down’s syndrome with signs of functional or cognitive deterioration.

Eisai will present interim results from the ongoing open-label extension study of the Phase 2b study of lecanemab in early Alzheimer’s disease. The presentation will focus on preliminary results concerning the effect of lecanemab on amyloid levels in the brain in subjects who participated in the core imaging subgroup.
 

Topic, session, date and time (CET) Topic

Lecanemab (BAN2401)

Session: Aβ targeting therapies in AD 2
Saturday March 13
Oral presentation: 13:15-13:30
Live Q&A Session: 17:30-18:00

Preliminary amyloid PET analysis in BAN2401 phase 2 open-label extension in subjects who participated in the core imaging subgroup

Lecanemab (BAN2401)

Session: β-amyloid diseases 
March 9-14
Poster P142 / #487

Elevated levels of soluble amyloid beta protofibrils in Down’s syndrome and Alzheimer’s disease
 

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This information was submitted for publication at 08:00 a.m. CET on March 5, 2021.  

For further information, please contact: 
Gunilla Osswald, CEO, BioArctic AB 
E-mail: gunilla.osswald@bioarctic.se 
Phone: +46 8 695 69 30 

Oskar Bosson, Vice President Communications and Investor Relations, BioArctic AB 
E-mail: oskar.bosson@bioarctic.se 
Phone: +46 70 410 71 80 

About lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) 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.

Currently, lecanemab is being studied in a pivotal Phase 3 clinical study in symptomatic early AD (Clarity AD), following the outcome of the Phase 2b clinical study (Study 201). In July of 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical (asymptomatic) 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 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 lecanemab 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 lecanemab 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. 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 Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.

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