In two separate phase 1 clinical studies conducted in collaboration with AbbVie (NYSE:), exidavnemab was tested on healthy volunteers to assess the safety, tolerability and pharmacokinetics of the candidate drug. The studies included 98 participants from different ethnic backgrounds, of which 85 received exidavnemab, either as an intravenous dose ranging from 100 to 6000 mg or a subcutaneous dose of 300 mg.
The results showed that exidavnemab was generally well-tolerated. with an excellent half-life of approximately 30 days. This together with the high affinity and selectivity toward the pathological aggregated forms of α-synuclein is key to maintain a high target binding in the brain.
“Data from these two studies support the continued clinical development of exidavnemab, and we are looking forward to starting the phase 2a study later this year,” said
The published article can be read in full here: https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6103
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 such investigational agents will successfully complete clinical development or gain health authority approval.
The information was released for public disclosure, through the agency of the contact person below, on
For further information, please contact:
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
About Exidavnemab
Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively bind and eliminate aggregated forms of alpha-synuclein such as oligomers and protofibrils and fibrillar forms, which participates in neurodegenerative disorders including Parkinson’s disease. The goal is to develop a disease modifying treatment that stops or slow down the progression of Parkinson’s disease.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and ALS. 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,
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https://news.cision.com/bioarctic/r/study-results-from-phase-1-studies-with-exidavnemab-published-in-the-journal-of-clinical-pharmacolog,c4028830
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https://mb.cision.com/Main/9978/4028830/2963458.pdf |
Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology |
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