Phase 1 Exidavnemab Study Results Published in The Journal of Clinical Pharmacology

STOCKHOLM, Aug. 27, 2024 -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced that phase 1 studies of exidavnemab have been published in The Journal of Clinical Pharmacology. Exidavnemab is a monoclonal antibody drug candidate targeting aggregated forms of the protein α-synuclein, implicated in diseases such as Parkinson's disease, while sparing the protein's normal physiological form.

The phase 1 clinical studies were conducted in collaboration with AbbVie and involved healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of exidavnemab. A total of 98 participants from diverse ethnic backgrounds were included in the studies, with 85 receiving the drug either intravenously (doses ranging from 100 to 6000 mg) or subcutaneously (300 mg).

Results indicated that exidavnemab was generally well-tolerated, exhibiting an excellent half-life of approximately 30 days. Its high affinity and selectivity for the pathological aggregated forms of α-synuclein are crucial for maintaining strong target binding in the brain.

Gunilla Osswald, CEO of BioArctic, commented on the findings, stating, "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."

Exidavnemab is a monoclonal antibody drug candidate specifically designed to bind and eliminate aggregated forms of alpha-synuclein, such as oligomers, protofibrils, and fibrillar structures, which are involved in neurodegenerative diseases like Parkinson's disease. The goal is to develop a disease-modifying treatment that can halt or slow the progression of Parkinson's disease.

BioArctic AB is a Swedish biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, including Alzheimer's, Parkinson's, and ALS. Founded in 2003 from Uppsala University research, BioArctic emphasizes innovative treatments in areas with significant unmet medical needs. The company collaborates with universities and global partners like Eisai in Alzheimer's research. BioArctic's project portfolio features both fully funded collaborations and in-house projects with substantial market and out-licensing potential. BioArctic's Class B share is listed on Nasdaq Stockholm Large Cap under the ticker BIOA B.

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