Latest data on lecanemab to be presented at Alzheimer’s Association International Conference (AAIC)
Stockholm, July 21, 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will hold several presentations at the Alzheimer’s Association International Conference (AAIC) to be held in Denver, Colorado and virtually from July 26 to 30, 2021. The presentations will include the latest data of the investigational anti-amyloid beta (Aβ) protofibril selective antibody lecanemab (BAN2401) for which the FDA has granted Breakthrough Therapy designation.
The presentations regarding lecanemab include oral presentations about the preliminary assessment of the clinical effect of lecanemab following 18 months of treatment in the open-label extension of the Phase 2b proof of concept study (201 study) in subjects with early Alzheimer’s disease and preliminary screening and baseline characteristics of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer’s disease.
Eisai oral presentations
| Asset in Development/Topic Number |
Topic/Planned Date and Time |
|
Lecanemab Oral presentation No.53143 |
AHEAD 3-45 Study: Preliminary Screening and Baseline Characteristics from a Placebo-Controlled, Double-Blind Study Evaluating Lecanemab Treatment in Participants with Preclinical Alzheimer’s Disease and Elevated (A45 Trial) and Intermediate (A3 Trial) Amyloid Oral presentation: July 29 (Thu) 8:00 AM-9:15 AM |
|
Lecanemab Oral presentation No.57780 |
Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open Label Extension of the Phase 2 Proof of Concept Study, BAN2401-G000-201, in Subjects with Early Alzheimer's Disease Oral presentation: July 29 (Thu) 1:00 PM-2:15 PM |
Eisai poster presentations
|
Asset in Development/Topic Number |
Topic/Planned Date and Time |
|
Lecanemab Poster No.54331 |
Baseline Characteristics for Clarity AD: A Phase 3 Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study Evaluating Lecanemab (BAN2401) On demand |
|
Lecanemab Poster No.57760 |
Plasma Aβ42:40 Ratio Tracks with Changes in Brain Amyloid PET SUVr in the Core and Open Label Extension of the Phase 2 Proof of Concept Study BAN2401-G000-201 Following Treatment with Lecanemab in Subjects with Early Alzheimer's Disease On demand |
|
Lecanemab Poster No.55360 |
Video Imaging of Structural Dynamics of Amyloid β Protofibrils On demand |
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.
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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
The information was released for public disclosure, through the agency of the contact persons above, on July 21, 2021, at 08.00 a.m. CET.
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 (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. 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 brain amyloid, 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. In June 2021, FDA granted lecanemab Breakthrough Therapy designation.
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 for the BAN2401 antibody, which was signed in December 2007, and the Development and Commercialization agreement for 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. 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.