BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed as a treatment for Parkinson’s disease and Multiple System Atrophy (MSA).
The first cohort in the ongoing clinical Phase 2a study EXIST evaluated a lower dose of exidavnemab compared to placebo in patients with Parkinson’s disease. An interim safety review showed that exidavnemab was safe and well tolerated. The positive outcome will result in the initiation of two further cohorts, to evaluate a higher dose of exidavnemab in comparison with placebo in patients with Parkinson’s disease as well as MSA.
“Exidavnemab is BioArctic’s second disease modifying treatment for severe brain diseases, building on a similar scientific approach as Leqembi®. Both originate from our antibody platform, selectively targeting aggregated, toxic misfolded proteins. I am pleased that the interim safety review of our phase 2a study EXIST of exidavnemab showed a good safety and tolerability profile as expected, supporting progression into higher doses in both Parkinson’s disease and MSA,” says Gunilla Osswald, CEO at BioArctic.
The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of exidavnemab and its pharmacokinetic profile. In addition, a broad range of biomarkers will be evaluated in plasma, cerebrospinal fluid (CSF), and using digital measurements.
Exidavnemab is being developed as a novel disease-modifying treatment for synucleinopathies such as Parkinson’s disease and MSA. Exidavnemab is a monoclonal antibody (mAb) that selectively targets pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregated alpha-synuclein damages nerve cells, and by selectively binding and removing these aggregates, exidavnemab is intended to preserve nerve cell function and slow the disease.
There is a large unmet medical need for slowing disease progression in diseases such as Parkinson’s disease and MSA. Exidavnemab has recently been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of MSA.
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