Novo Nordisk, after mulling the implications of a phase 3 fail, has given up on a late-stage kidney drug acquired in a $1.3 billion deal.
The Danish pharma bought the nonsteroidal mineralocorticoid receptor antagonist, called ocedurenone, from KBP Biosciences a year ago. The thinking was that the drug could be a possible rival to Bayer’s approved chronic kidney disease (CKD) drug Kerendia.
But those ambitions went up in flames in July when a prespecified interim analysis of a phase 3 trial in hypertension and advanced CKD showed the trial had missed its primary endpoint of triggering a significant change in systolic blood pressure, leading Novo to halt the study. That clinical failure came with a financial hit for the Big Pharma to the tune of an $816.5 million impairment loss.
At the time, Novo said it was evaluating whether ocedurenone showed potential in other therapeutic areas. The company had previously alluded to plans to launch phase 3 trials in “additional cardiovascular and kidney disease indications in the coming years.”
But, after analyzing “detailed trial data,” Novo has now decided to terminate the program completely, it confirmed in its third-quarter earnings release this morning.
With ocedurenone gone, the only CKD program still listed in Novo’s pipeline is semaglutide—the main ingredient behind Rybelsus, Ozempic and Wegovy—which has secured success this year in a phase 3 study in reducing the risk of kidney disease progression in patients with Type 2 diabetes.