Chinook Therapeutics gets orphan drug status from EC for atrasentan in IgAN
Chinook Therapeutics, a US-based biopharma company, has secured orphan drug designation for atrasentan from the European Commission (EC) for the treatment of primary IgA nephropathy (IgAN).
The decision from the EC comes after the adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
Atrasentan has been designed to be a selective and potent inhibitor of the endothelin A receptor (ETA) which can potentially offer benefits in various chronic kidney diseases by lowering proteinuria and have direct anti-inflammatory and anti-fibrotic effects to preserve the functions of kidneys.
Currently, Chinook Therapeutics is enrolling participants in the phase 3 Align study in IgA nephropathy and the phase 2 AFFINITY study in proteinuric glomerular diseases.
The US biopharma company anticipates releasing data from the IgAN patient cohort of the phase 2 AFFINITY study in the first half of next year, with data from one or more additional cohorts likely to come out in the latter half of 2022.
Alan Glicklich — chief medical officer of Chinook Therapeutics said: “We are pleased the European Commission has granted Chinook orphan drug designation in the EU for atrasentan for IgA nephropathy, a rare, severe chronic kidney disease for which there are no approved therapies.
“Orphan drug designation in the EU represents an important regulatory milestone that has the potential to expedite the global clinical development of atrasentan, a potent and selective ETA antagonist. We are highly encouraged and look forward to continue exploring atrasentan’s proteinuria-lowering, anti-inflammatory and anti-fibrotic effects in patients with IgAN in the ongoing pivotal phase 3 ALIGN study.”