BioArctic has commenced its Phase IIa EXIdavnemab Synucleinopathy Trial (EXIST) by dosing the first patient with exidavnemab, a monoclonal antibody being investigated as a potential treatment for Parkinson's disease. The trial, conducted in Europe, is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of the antibody in individuals with Parkinson's disease. This marks a significant step in BioArctic's efforts to expand its research portfolio and address neurological disorders.
Trial Design and Objectives
The EXIST trial aims to enroll at least 24 subjects, divided into two arms of 12 participants each. The study will assess different dosage levels of exidavnemab against a placebo. Researchers will also evaluate a range of biomarkers in plasma and cerebrospinal fluid through digital measurements. The primary objective is to determine the tolerability and safety of exidavnemab in this patient population.
Mechanism of Action
Exidavnemab is being developed as a disease-modifying treatment. It is designed to halt or slow the progression of Parkinson's disease and other synucleinopathies by targeting and eliminating aggregated forms of alpha-synuclein. Alpha-synuclein is a protein that plays a crucial role in the development and progression of Parkinson's disease.
Prior Clinical Data
Two previous Phase I trials of exidavnemab, conducted in collaboration with AbbVie, have indicated a favorable tolerability profile and a half-life of approximately 30 days. These findings support further investigation of the antibody's potential as a therapeutic agent for Parkinson's disease.
BioArctic's Broader Portfolio
BioArctic is a Sweden-based company focused on developing treatments for neurodegenerative diseases. Their portfolio includes Leqembi, an Alzheimer's therapy developed in partnership with Eisai, for which Eisai handles worldwide commercialization. BioArctic also has several antibodies targeting Parkinson's disease and ALS, as well as other Alzheimer's projects. Many of these programs utilize BrainTransporter technology to enhance antibody transport across the blood-brain barrier, potentially improving treatment efficacy.
Gunilla Osswald, CEO of BioArctic, stated, "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."
