Novo Nordisk said Wednesday morning a small molecule that it recently bought for up to $1.3 billion has failed a Phase 3 trial in chronic kidney disease.
The Danish drugmaker said it will take an impairment loss of about DKK 5.7 billion (approximately $816 million) in the second quarter of this year as a result of the drug’s flop in the late-stage CLARION-CKD study.
Last October, Novo Nordisk acquired the drug candidate, dubbed ocedurenone, from Singapore-based KBP Biosciences, which conducted the Phase 3. The large trial tested the tablet in about 650 adults with chronic kidney disease and uncontrolled hypertension, according to the US federal trials database.
A win would have given Novo a shot at competing with Bayer’s Kerendia, which snagged an approval for chronic kidney disease in July 2021. Both are non-steroidal mineralocorticoid receptor antagonists.
Novo said after a prespecified interim analysis, an independent data monitoring committee concluded that the trial would not pass muster on the primary endpoint of changes in systolic blood pressure. That led the drugmaker to decide to stop the trial.
The pharma giant, one of the largest in the world thanks to its popular obesity and diabetes franchise, said it will evaluate further development of the drug in other indications.
At the time of the deal last fall, Novo said it planned to test the drug in additional late-stage trials in other cardiovascular and kidney disease indications, saying the deal could serve as a launchpad to expand the company into “other serious chronic diseases, including through novel drug modalities.”