First patient treated in Phase 2a Parkinson's study

BioArctic AB, a research-driven biopharmaceutical company, has moved forward in its clinical advancement of exidavnemab, a monoclonal antibody aimed at combating Parkinson's disease. The company announced that the first participant in its Phase 2a trial, identified as the EXIST (EXIdavnemab Synucleinopathy Trial) study, has received a dose of the investigational drug. This study, set in Europe, is structured to assess the safety and tolerability of the drug in individuals with Parkinson's disease.

Exidavnemab is designed to target the aggregated forms of the protein α-synuclein. These aggregates are believed to contribute to the progression of Parkinson's disease and other neurological conditions. The Phase 2a trial is both randomized and double-blind, ensuring that neither the participants nor the researchers know who is receiving the drug versus a placebo. The trial will enroll at least 24 patients, divided into two groups of 12. The first group will receive a lower dose of the drug or a placebo, while the second group will be administered a higher dose or a placebo. The study will not only focus on primary safety endpoints but will also evaluate a wide array of biomarkers in the blood and cerebrospinal fluid, alongside digital measurements.

Gunilla Osswald, CEO of BioArctic, expressed her enthusiasm about reaching this milestone. She emphasized that this development is a significant progression in BioArctic’s mission to expand their research portfolio and provide better lives for individuals and families affected by various neurological disorders.

The initiation of this phase follows promising results from two earlier Phase 1 studies conducted in collaboration with AbbVie. Published in The Journal of Clinical Pharmacology, these studies showed that exidavnemab is generally well-tolerated and has a substantial half-life of about 30 days. The drug’s high affinity and selectivity for pathological aggregated forms of α-synuclein were also highlighted, which is crucial for maintaining effective target binding in the brain. These findings have laid a strong foundation for advancing into the Phase 2a trial.

Exidavnemab is an investigational drug currently under clinical development, and its efficacy and safety are still being evaluated. There is no certainty that it will successfully complete clinical trials or receive approval from health authorities.

BioArctic AB, based in Stockholm and listed on Nasdaq Stockholm, is committed to developing innovative treatments for neurodegenerative diseases. The company is notable for its development of Leqembi® (lecanemab) in partnership with Eisai, a drug that has been shown to slow the progression of early Alzheimer's disease and reduce cognitive impairment. Besides Leqembi, BioArctic's research portfolio includes antibodies targeting Parkinson's disease and ALS, as well as other projects addressing Alzheimer's disease. Many of these projects utilize BioArctic's BrainTransporter™ technology, which helps transport antibodies across the blood-brain barrier to enhance treatment efficacy.

This announcement marks a hopeful progression in the quest to develop disease-modifying treatments for Parkinson's disease and underscores BioArctic's ongoing commitment to pioneering therapies for neurodegenerative conditions.