Novo Concludes Phase III Kidney Disease Trial, Faces $800M Q2 Impairment

Novo Nordisk revealed on Wednesday that its Phase III trial for a potential treatment targeting hypertension and chronic kidney disease did not achieve its primary goal. Consequently, the Danish pharmaceutical company has decided to halt the study and expects to record a financial impairment of DKK 5.7 billion, equivalent to $818.9 million, in the second quarter of 2024.

The halted study, named the CLARION-CKD trial, was aimed at evaluating the drug ocedurenone, a mineralocorticoid receptor antagonist. This drug was acquired by Novo Nordisk from KBP Biosciences in a deal finalized in October 2023, which could have been valued at up to $1.3 billion. Prior to Novo's acquisition, ocedurenone had already been tested in nine studies and had demonstrated positive outcomes, particularly in a Phase IIb trial where it significantly improved systolic blood pressure.

However, during the Phase III trial, an interim analysis conducted by an independent monitoring committee found that the drug did not meet the primary endpoint, which was to show a change in systolic blood pressure from the baseline to week 12 of the trial. Following these findings, Novo Nordisk decided to discontinue the CLARION-CKD trial.

The company acknowledged that the impairment loss from discontinuing the trial is expected to negatively impact its operating profit growth for the year, estimated at around 6% at constant exchange rates. Meanwhile, Novo Nordisk is still considering the potential of ocedurenone for other medical uses.

Analysts from BMO Capital Markets described the outcome as a “modest negative” for Novo Nordisk. They suggested that investors might view this development as a minor setback and not as a significant detriment to broader revenue projections. The analysts also pointed out that such failures are uncommon for Novo Nordisk.

In their assessment, the analysts noted that while the failure of ocedurenone in treating chronic kidney disease is disappointing, especially for Novo’s broader strategy to expand its cardiovascular and emerging therapeutic areas, the drug’s anticipated revenue was relatively limited. They had projected a peak revenue contribution of $2.4 billion from ocedurenone before the trial’s discontinuation.

This setback occurs even as Novo Nordisk continues to achieve clinical milestones with its GLP-1 drug, semaglutide. In May 2024, a Phase III trial showed that semaglutide reduced the risk of death by 20% in type 2 diabetes patients with chronic kidney disease compared to a placebo. Additionally, semaglutide has recently been found to induce more significant weight loss in women than in men with a common type of heart failure.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!