The monoclonal antibody is used for treating Parkinson’s disease. Credit: siro46/Shutterstock.

BioArctic has dosed the first subject with the monoclonal antibody, exidavnemab, in the randomised Phase IIa EXIdavnemab Synucleinopathy Trial (EXIST) to treat Parkinson’s disease.

Conducted in Europe, the placebo-controlled, double-blind trial aims to recruit a minimum of 24 subjects, divided into two arms of 12. It is designed to assess the tolerability and safety of the antibody.

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Each cohort will test different dosage levels of exidavnemab against a placebo, while also evaluating a range of biomarkers in plasma, cerebrospinal fluid via digital measurements.

BioArctic CEO Gunilla Osswald said: “We are very excited that the first patient with Parkinson’s disease has now been dosed in the EXIST Phase IIa study with exidavnemab.

“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.”

The two recent Phase I trials of the therapy conducted along with AbbVie indicated that exidavnemab has a tolerability profile and a half-life of nearly 30 days.

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Exidavnemab is being developed as a potential disease-modifying treatment, aiming to halt or slow the progression of Parkinson’s disease and other synucleinopathies by targeting and eliminating various aggregated forms of alpha-synuclein.

Sweden-based BioArctic is at the forefront of creating treatments for neurodegenerative diseases, including the Alzheimer’s therapy Leqembi, developed in partnership with Eisai. Eisai handles worldwide commercialisation for Leqembi.

BioArctic’s portfolio extends beyond Leqembi, with several antibodies targeting Parkinson’s disease and ALS, as well as other Alzheimer’s projects.

Many of these leverage the BrainTransporter technology to potentially enhance treatment efficacy by facilitating antibody transport across the blood-brain barrier.

In October 2023, BioArctic and Eisai revealed Phase III data for a subcutaneous formulation of Leqembi.

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