Chinook Therapeutics, Inc. (NASDAQ:KDNY) announced that the European Commission has granted orphan drug designation for BION-1301 for the treatment of primary IgA nephropathy (IgAN).
The regulatory grant follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
Eric Dobmeier, chief executive officer, commented : “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. We are encouraged by the data generated to date demonstrating durable reductions in mechanistic biomarkers and corresponding proteinuria reductions.”
The company is planning to evaluate BION-1301 in a pivotal phase 3 clinical study in 2023.
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease globally and a leading cause of chronic kidney disease (CKD)
Orphan drug designation is granted to medicines that are intended to treat, prevent or diagnose a life-threatening or chronically debilitating rare disease with a prevalence in the European Union (EU) of fewer than five in 10,000 and with either no currently approved method of diagnosis, prevention or treatment or with significant benefit to those affected by the disease.
Price Action: Chinook shares are trading about 3 percent higher at $18.01 on Tuesday at the time of publication.
