BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today the successful dosing of the first patient in the EXIST Phase 2a study evaluating exidavnemab for Parkinson’s disease. Exidavnemab, a monoclonal antibody, specifically targets aggregated forms of the protein α-synuclein, which is believed to contribute to the progression of Parkinson’s and other neurological disorders.
The Phase 2a trial, titled EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of exidavnemab in Parkinson’s patients. Conducted in Europe, the trial will enroll at least 24 participants, divided into two cohorts of 12 patients each.
- Cohort 1: Receives either a lower dose of exidavnemab or placebo.
- Cohort 2: Receives either a higher dose of exidavnemab or placebo.
In addition to safety and tolerability as primary endpoints, researchers will assess a comprehensive set of biomarkers through plasma, cerebrospinal fluid (CSF) samples, and advanced digital measurements to gather detailed insights.
“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 α-synuclein, key to maintaining a high target binding in the brain, laid the foundation for the Phase 2a study.