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BioArctic announces start of Phase 1 study of ABBV-0805 for Parkinson’s disease

Regulatory

Stockholm, Sweden, March 13, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first clinical study with ABBV-0805 has started in the U.S. AbbVie is responsible for the clinical development of ABBV-0805. The Phase 1 study in healthy volunteers will investigate the safety and tolerability of ABBV-0805.

ABBV-0805 is the most advanced within the portfolio of alpha-synuclein targeting antibodies in-licensed by AbbVie from BioArctic in December 2018. The antibody is being evaluated as a disease modifying treatment for Parkinson’s disease.

ABBV-0805 is a result of a strategic research alliance between BioArctic and AbbVie focused on the development of a potential immunotherapy for Parkinson’s disease.

“It is gratifying that our partner AbbVie has started the first clinical trial, a Phase 1 study, with ABBV-0805. We are now looking forward to ABBV-0805 moving forward in the clinical program and developing into a therapy with the potential to provide meaningful advances for patients with Parkinson’s disease,” said Gunilla Osswald, Ph.D., CEO, BioArctic.

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

Christina Astrén, IR & Communications Director, BioArctic AB
E-mail: christina.astren@bioarctic.se
Telephone: + 46 70 835 43 36

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on March 13, 2019, at 10.30 p.m. CET.

Notes to editors

About Parkinson’s disease
Parkinson’s disease is a progressive disease of the nervous system that is associated with reduced levels of dopamine in the brain. Tremor and movement disturbances are the pathological hallmarks of the disease, but it is also characterized by dementia, depression, sleep disturbance and other symptoms. As the second most common neurodegenerative disease, after Alzheimer’s disease, Parkinson’s disease affects a large number of individuals and their families. Many who fall ill are still at working age resulting in considerable financial consequences for the individual and society. Patients with Parkinson’s disease suffer from an extensive loss of nerve cells in a part of the brain associated with movement. These nerve cells contain the so-called Lewy bodies consisting of aggregated misfolded alpha-synuclein that are associated with cell loss. Alpha-synuclein aggregates can also be released from the cells and travel to neighboring cells, whereby the disease is spread from one area of the brain to another. Research has shown that mutations in the alpha-synuclein gene lead to Parkinson’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 our 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.