Novo's Kidney Drug Fails Phase 3, Causes $816M Loss

Novo Nordisk's late-stage trial for its kidney disease drug ocedurenone has ended in disappointment. The drug, which the Danish pharmaceutical giant acquired from KBP Biosciences for up to $1.3 billion last year, failed to achieve its primary objective in a phase 3 trial aimed at patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

Ocedurenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), was being tested in a study named CLARION-CKD. This trial included 652 patients and spanned 24 weeks. However, an interim analysis by an independent data monitoring committee revealed that the trial did not meet its primary endpoint. Specifically, the drug did not lead to a significant change in systolic blood pressure from baseline by Week 12. Consequently, Novo Nordisk has decided to halt the trial.

Novo Nordisk had hoped that ocedurenone would become a significant competitor to Bayer’s CKD drug Kerendia. Approved by the FDA in June 2021, Kerendia is also an nsMRA and has shown promise in improving both renal and cardiovascular health. Bayer's clinical trials demonstrated that Kerendia could reduce the risk of kidney and heart issues in adults with CKD related to Type 2 diabetes, and it was also associated with lower blood pressure levels.

The failure of the phase 3 trial will have substantial financial repercussions for Novo Nordisk. The company announced that this setback would lead to an impairment loss of 5.7 billion Danish kroner (approximately $816.5 million) for the second quarter of the year. This financial hit will diminish the company’s anticipated operating profit growth by about 6 percentage points, as compared to previous forecasts shared in their financial reports.

Despite this setback, Novo Nordisk is not entirely abandoning ocedurenone. The company stated that it is currently assessing other potential therapeutic areas where the drug might still prove effective.

This failure marks a significant setback for Novo Nordisk, which had leveraged some of its revenue from weight loss drugs to invest in ocedurenone. This investment was aimed at expanding their portfolio and establishing a foothold in the competitive market for CKD treatments.

In summary, Novo Nordisk's attempt to develop a new treatment for patients with uncontrolled hypertension and advanced CKD has not succeeded. The failure of the phase 3 trial for ocedurenone means a substantial financial loss and a re-evaluation of the drug's future applications. Nonetheless, the company remains hopeful as it explores other therapeutic opportunities for the drug.