Novo's kidney disease drug fails to improve blood pressure in phase 3, spurring $816M loss

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来源: FierceBiotech

Novo Nordisk's asset failed to meet the main goal of a phase 3 trial evaluating patients with uncontrolled hypertension and advanced chronic kidney disease.

Novo Nordisk’s late-stage kidney disease drug has failed to evoke significant change in systolic blood pressure, a loss that will cost the Danish drugmaker more than $800 million.

The asset in question is ocedurenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that the pharma picked up from KBP Biosciences last year in a deal worth up to $1.3 billion.

Now, ocedurenone has failed to meet the main goal of a phase 3 trial for patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

The study, dubbed CLARION-CKD, enrolled 652 patients and was designed to run for 24 weeks. At a prespecified interim analysis, an independent data monitoring committee found that the trial didn’t meet its primary endpoint, which was change in systolic blood pressure from baseline by Week 12. In light of the miss, Novo is stopping the trial.

The Danish pharma used some of its weight loss drug windfall to purchase ocedurenone as a possible rival to Bayer’s CKD drug Kerendia. The FDA had approved that nsMRA in June 2021.

Bayer’s late-stage trials of Kerendia had focused on measures of renal and cardiovascular health, leading to the approval of the drug as a way to reduce the risk of kidney and heart problems in adults with CKD associated with Type 2 diabetes. Kerendia was also tied to a reduction in blood pressure.

Novo’s phase 3 failure will spur an impairment loss of 5.7 billion Danish kroner ($816.5 million) for the second quarter of this year, according to a June 26 company release. This will negatively impact the company’s expected operating profit growth by about 6 percentage points compared to the outlook shared in previous financial reports.

The pharma said it is currently evaluating the further development of ocedurenone in other therapeutic areas.

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