Chinook Therapeutics gets orphan drug status from EC for atrasentan in IgAN

TAGS

Chinook Therapeutics, a US-based biopharma company, has secured orphan drug designation for atrasentan from the (EC) for the treatment of primary (IgAN).

The decision from the EC comes after the adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the (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.

See also  Torrent Pharmaceuticals gets rights to generic of Pfizer’s oral Covid-19 treatment

Currently, is enrolling participants in the phase 3 Align study in IgA nephropathy and the phase 2 AFFINITY study in proteinuric glomerular diseases.

Chinook Therapeutics gets orphan drug status from European Commission for atrasentan in primary IgA nephropathy

Chinook Therapeutics gets orphan drug status from European Commission for atrasentan in primary IgA nephropathy. Photo courtesy of Dimitris Vetsikas from Pixabay.

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.

See also  Tapestry to acquire rival fashion company Capri Holdings for $8.5bn

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.”


Discover more from Business-News-Today.com

Subscribe to get the latest posts sent to your email.

CATEGORIES
TAGS
Share This