Research & Development
BioArctic reports approval by US FDA of Investigational New Drug Application for ABBV-0805
12 February 2019 -

BioArctic AB (STO:BIOA B), a Swedish research-based biopharmaceutical company, announced on Monday the receipt by AbbVie Inc (NYSE:ABBV) of approval from the US Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for ABBV-0805.

The company added that this approval is a requirement to start clinical trials in the US.

According to the company, ABBV-0805, previously named BAN0805, is the most advanced within the portfolio of alpha-synuclein targeting antibodies in-licensed by AbbVie from BioArctic in December 2018. This antibody is being evaluated as a disease modifying treatment for Parkinson's disease. The first clinical study is planned to start in 2019.

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. AbbVie is responsible for the clinical development of ABBV-0805.

BioArctic is focused 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.



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