“This positive opinion recommending orphan medicinal product designation for exidavnemab in MSA in the EU and the corresponding orphan drug designation in the US, along with the approval to include MSA patients in our ongoing phase 2 study EXIST in Parkinson’s disease, is fully in line with our ambition to support and develop treatments for a broader scope of neurodegenerative disorders,” says Gunilla Osswald, CEO at BioArctic.

Exidavnemab

Exidavnemab is being developed as a novel disease-modifying treatment for neuronal synuclein diseases such as MSA and Parkinson’s disease. Exidavnemab is a monoclonal antibody (mAb) that selectively targets alpha-synuclein aggregates, such as oligomers, protofibrils as well as fibrillar forms. By promoting the clearance of aggregated alpha-synuclein, exidavnemab may reduce the spreading and the negative effects of alpha-synuclein. Thereby cellular function and survival may be preserved, and disease progression ultimately slowed down.