BioArctic Begins Patient Dosing in Exist Phase 2a Study in Parkinson’s Disease

BioArctic AB (publ), a Swedish research-based biopharma company, announced that the first patient has been dosed with exidavnemab in the EXIST phase 2a study, in Parkinson’s disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein a-synuclein, believed to play a role in the disease progression in different neurological disorders including Parkinson’s disease.

The phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study in Parkinson’s disease patients to evaluate the safety and tolerability of exidavnemab. The study is conducted in Europe and at least 24 patients will be recruited in,divided into two cohorts of 12 (Cohort 1 and Cohort 2). Participants in Cohort 1 will receive either a lower dose of exidavnemab or placebo and participants in Cohort 2 will receive either a higher dose of exidavnemab or placebo. In addition to the primary endpoints, a broad range of biomarkers will be evaluated, in plasma, cerebrospinal fluid (CSF) and using digital measurements.

“We are very excited that the first patient with Parkinson’s disease has now been dosed in the EXIST phase 2a study with exidavnemab,” said Gunilla Osswald, CEO at BioArctic. “It marks an important next step on BioArctic’s pioneering journey to broaden our research portfolio and help more patients and families with different neurological disorders to a better life.”

Recently, the results of two separate phase 1 studies of exidavnemab, conducted in collaboration with AbbVie, were published in The Journal of Clinical Pharmacology. The results showed that exidavnemab is generally well-tolerated, with an excellent half-life of approximately 30 days. These data together with the high affinity and selectivity toward the pathological aggregated forms of a-synuclein, key to maintaining a high target binding in the brain, laid the foundation for the phase 2a study.

Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively bind and eliminate pathological aggregated forms of alpha-synuclein such as oligomers and protofibrils as well as fibrillar forms, all of which are believed to play a role in neurodegenerative disorders including Parkinson’s disease. The goal is to develop a disease modifying treatment that stops or slows down the progression of Parkinson’s disease or other synucleinopathies.

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases.

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