"We are pleased the European Commission has granted Chinook orphan drug designation in the EU for BION-1301 for IgA nephropathy, a serious, progressive disease for which there are limited treatment options," said Eric Dobmeier, chief executive officer of Chinook Therapeutics. "Orphan drug designation in the EU represents an important regulatory milestone that has the potential to expedite the global clinical development of BION-1301, an anti-APRIL monoclonal antibody with disease-modifying potential in IgAN. We are encouraged by the data generated to date demonstrating durable reductions in mechanistic biomarkers and corresponding proteinuria reductions and look forward to evaluating BION-1301 in a pivotal phase 3 study in 2023."