Novo Nordisk's Phase III Ocedurenone Flop Costs $816M

Novo Nordisk will incur a substantial financial setback amounting to DKr5.7bn ($816 million) after its drug candidate ocedurenone failed to achieve its primary endpoint in a Phase III trial. The CLARION-CKD trial (NCT04968184) aimed to treat patients suffering from uncontrolled hypertension and moderate or severe chronic kidney disease (CKD), specifically stages 3b and 4. However, the trial results were disappointing, leading to the termination of the study.

The Danish pharmaceutical giant had acquired ocedurenone from KBP Biosciences in a $1.3 billion deal in 2023. At the time of the acquisition, KBP Biosciences was already conducting the Phase III trial. Following the unsuccessful trial results, Novo Nordisk is set to recognize an impairment loss of $816 million related to the drug in the second quarter of 2024.

The trial's design included a pre-planned interim analysis conducted by an independent data monitoring committee after 12 weeks of treatment. This analysis revealed that the trial had not achieved its primary endpoint, which was a change in systolic blood pressure (SBP). As a result, Novo Nordisk decided to halt the study.

The trial aimed to enroll around 600 participants from 150 sites across the United States, Europe, and Asia, with the first patient being dosed at the end of 2021. Despite the setback, Novo Nordisk had previously announced intentions to explore the potential of ocedurenone for other cardiovascular and kidney disease indications in future studies.

Kajal Jaddoo, a senior pharma analyst at GlobalData, commented on the complexity and challenges associated with CKD clinical trials. She noted that these trials have broad and intricate primary endpoints, leading to the failure of several promising drug candidates in late-stage trials in recent years. This trend not only imposes a significant economic burden on pharmaceutical companies but also disappoints patients awaiting new CKD treatments.

Jaddoo further explained that the difficulties in CKD drug development might prompt pharmaceutical companies to redirect their investments towards more lucrative disease areas. This shift could negatively impact the production of new CKD medications on the global market.

Ocedurenone is a non-steroidal, mineralocorticoid receptor antagonist. It works by blocking aldosterone from binding to mineralocorticoid receptors in both epithelial and non-epithelial tissues. Aldosterone binding is known to increase blood pressure and exacerbate kidney disease through mechanisms such as sodium reabsorption.

Before its acquisition by Novo Nordisk, KBP Biosciences had conducted a Phase IIb trial (NCT03574363) for ocedurenone, which met its primary endpoint. The drug demonstrated a clinically meaningful and statistically significant improvement in systolic blood pressure among the same patient population.

Novo Nordisk, with a market capitalization of $499 billion as per GlobalData’s Pharmaceutical Intelligence Center, will now reevaluate the future development of ocedurenone in light of the recent trial failure.

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