Pictured: Exterior of Novo Nordisk's location in Mainz, Germany/iStock, Victor Golmer

图为：诺和诺德位于德国美因茨/维克托·戈尔默（Victor Golmer）伊斯托克（iStock）的外景

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..

诺和诺德周三宣布，其高血压和慢性肾脏病候选人的III期试验未能达到主要终点，这家丹麦制药商决定停止该研究，并在2024年第二季度造成57亿丹麦克朗（8.189亿美元）的减值损失。。

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.

晚期CLARION-CKD试验正在研究ocedurenone，一种盐皮质激素受体拮抗剂，2023年10月Novo从KBP Biosciences收购，这笔交易可能价值13亿美元。当Novo购买该药物时，它之前已经进行了9项研究，并在IIb期试验中达到了主要终点，显示收缩压有统计学意义上的显着改善。

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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.

然而，在III期试验的中期分析中，一个独立的监测委员会发现，该试验没有达到收缩压从基线到第12周变化的主要终点。因此，Novo决定停止CLARION-CKD试验。

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.

Novo表示，由此产生的第二季度减值损失预计将对其今年以恒定汇率计算的营业增长利润产生约6%的负面影响。至于ocedurenone，该公司表示，目前正在评估其他适应症的进一步发展。

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..

BMO资本市场分析师在给投资者的一份报告中表示，这一消息对Novo来说是一个“温和的负面消息”，他们预计投资者会将这一消息视为“只是一个轻微的挫折”，“对更广泛的收入预期贡献很小”。分析师们还将第三阶段的失败称为Novo的“罕见失误”。。

“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.

分析师写道：“虽然ocedurenone在[慢性肾脏疾病]方面的失败令扩大Novo心血管和新兴治疗组合的更广泛计划感到沮丧，但我们估计，在今天宣布之前，ocedurenone的总收入潜力仅贡献了24亿美元的峰值。”。

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..

Novo使用ocedurenone的试验失败之际，这家丹麦制药商继续发现其重磅炸弹GLP-1药物在临床上取得了成功。2024年5月，semaglutide在一项III期研究中，与安慰剂相比，患有慢性肾病的2型糖尿病患者的死亡风险降低了20%。最近还发现，与患有常见类型心力衰竭的男性相比，Semaglutide可使女性体重减轻更多。。

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

泰勒·帕肯（Tyler Patchen）是BioSpace的一名全职作家。你可以通过tyler.patchen@biospace.com.在LinkedIn上关注他。