Novo Ends Phase III Kidney Disease Trial, Incurs More Than $800M Q2 Impairment Loss

2024-06-27

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Pictured: Exterior of Novo Nordisk's location in Mainz, Germany/iStock, Victor Golmer Novo Nordisk announced Wednesday that a Phase III trial of its hypertension and chronic kidney disease candidate failed to hit the primary endpoint, with the Danish drugmaker deciding to discontinue the study and incur an impairment loss of DKK 5.7 billion ($818.9 million) in the second quarter of 2024. The late-stage CLARION-CKD trial was investigating ocedurenone, a mineralocorticoid receptor antagonist, which Novo acquired from KBP Biosciences in October 2023 in a deal potentially worth $1.3 billion. When Novo purchased the drug, it had previously gone through nine studies and met its primary endpoint in a Phase IIb trial, showing a statistically significant improvement in systolic blood pressure. However, during the Phase III trial’s interim analysis, an independent monitoring committee identified that the trial did not meet its primary endpoint of a change in systolic blood pressure from baseline to week 12. As a result, Novo has decided to discontinue the CLARION-CKD trial. Novo said that the resulting Q2 impairment loss will have an estimated negative impact of around 6% on its operating growth profit at constant exchange rates this year. As for ocedurenone, the company said further development for other indications is currently being evaluated. BMO Capital Markets analysts in a note to investors said that the news was a “modest negative” for Novo and they expect investors to see the news as “only a minor setback” and a “minor contributor to broader revenue expectations.” The analysts also chalked up the Phase III failure as a “rare miss” for Novo. “While ocedurenone’s failure in [chronic kidney disease] is frustrating for broader plans to expand Novo’s cardiovascular and emerging therapeutics portfolio, we estimate total ocedurenone revenue potential only contributing a peak of $2.4B before today’s announcement,” the analysts wrote. Novo’s trial failure with ocedurenone comes as the Danish drugmaker continues to find clinical success with its blockbuster GLP-1 drug. In May 2024, semaglutide in a Phase III study lowered the risk of death by 20% in type 2 diabetes patients with chronic kidney disease compared to a placebo. Semaglutide was also recently found to induce a greater amount of weight loss in women than in men who have a common type of heart failure. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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