BioArctic AB (publ), a Swedish biotech firm focused on research, has revealed the commencement of patient dosing with their experimental drug, exidavnemab, in the phase 2a EXIST trial dedicated to those battling Parkinson’s disease. This drug is a monoclonal antibody tailored to treat the aggregated forms of the protein a-synuclein, which are thought to contribute to the advancement of various neurological impairments, including Parkinson’s.
The EXIST phase 2a study, which stands for EXIdavnemab Synucleinopathy Trial, is structured as a randomized, double-blind, and placebo-controlled experiment involving Parkinson’s patients, aiming to assess the safety and tolerability of exidavnemab. The study is being conducted across various European locations and plans to enroll a minimum of 24 participants grouped into two cohorts of 12. Participants in Cohort 1 are set to receive either a lower dose of exidavnemab or a placebo, while those in Cohort 2 will receive a higher dose or placebo. Besides focusing on primary endpoints, the trial will also measure extensive biomarkers in plasma and cerebrospinal fluid (CSF), along with digital assessments.
BioArctic’s CEO, Gunilla Osswald, expressed enthusiasm about reaching this critical milestone: “We are thrilled to have dosed the first Parkinson’s patient in the EXIST phase 2a study, marking a significant stride in expanding BioArctic’s cutting-edge research and offering hope to patients and families facing various neurological conditions.”
Recently published findings from two separate phase 1 studies of exidavnemab, in partnership with AbbVie in The Journal of Clinical Pharmacology, highlighted the drug’s general safety and its long half-life of about 30 days. This data complements exidavnemab’s strong specificity and affinity for the pathological forms of a-synuclein, essential to ensuring enhanced target binding within the brain, supporting the initiation of the phase 2a study.
Exidavnemab, a candidate for monoclonal antibody therapy, is specifically engineered to bind and eliminate harmful formations of alpha-synuclein, like oligomers, protofibrils, and fibrillar forms. These structures are believed to influence the progression of neurodegenerative diseases, such as Parkinson’s disease. The end goal is to create a treatment that modifies the disease by halting or delaying its progression.
Based in Sweden, BioArctic AB (publ) is dedicated to using innovative approaches to tackle neurodegenerative illnesses, endeavoring to devise treatments that slow or stop disease progression.