KBP Biosciences is seeking to regain control of its heart drug ocedurenone from Novo Nordisk after a troubled $1.3 billion agreement and subsequent allegations of fraud.
According to a source familiar with the matter, the Singapore-based biotech has brought in external experts to reassess the drug’s clinical potential, even after it failed a phase 3 trial in 2024. The company is reportedly considering running another late-stage study, possibly targeting a narrower patient population and working with the U.S. Food and Drug Administration on a more focused indication than the broader group of chronic kidney disease patients with uncontrolled hypertension evaluated in the Clarion-CKD trial.
Before pursuing that path, however, KBP would need to regain the asset from Novo Nordisk and secure additional funding for a new phase 3 program, both of which are complicated by an ongoing arbitration dispute between the two companies in New York.
In a statement on Tuesday, KBP Biosciences declined to comment on the legal case but said it remains committed to defending its position and asserting its rights. The company also maintained that ocedurenone could provide meaningful clinical benefit to millions of patients with hypertension who lack adequate treatment options and that the drug retains significant societal value.
The biotech added that it would be open to collaborating with Novo Nordisk if the Danish drugmaker opts to resume clinical development. Novo, for its part, declined to comment on the legal proceedings.
Novo Nordisk discontinued development of ocedurenone in November 2024, a little while after the Clarion-CKD trial failed to meet its primary endpoint of reducing systolic blood pressure. The company recorded an impairment charge of nearly $820 million, effectively assigning no commercial value to the drug after having acquired it in 2023 for more than $800 million upfront plus an additional $500 million in potential milestones.
However, court filings indicated that a subsequent analysis, conducted after addressing concerns in the statistical evaluation, showed the trial met only one of its two predefined futility criteria. In the new analysis, ocedurenone lowered systolic blood pressure by 4.3 mmHg compared to the placebo, just missing the 5 mmHg limit for futility but still showing a significant result with a p-value of 0.002.
Although the study protocol required only a single endpoint to trigger a futility determination, KBP Biosciences has said that Novo Nordisk acted prematurely in discontinuing the entire program, overlooking what it believes to be the remaining potential of ocedurenone.
From Novo Nordisk’s perspective, however, data from a site in Bulgaria appeared to heavily influence both the earlier positive phase 2 results that paved the way for the $1.3 billion deal and a seemingly favorable signal within the otherwise unsuccessful Clarion-CKD trial. The company has accused KBP of deliberately failing to disclose this information in order to secure the acquisition, while KBP Biosciences maintains that Novo just did not conduct sufficient due diligence before moving forward with the deal.
What Went Wrong in Earlier Trials
The journey has not been easy for KBP Biosciences. Initial trials of the cardiovascular drug failed to meet key endpoints, raising concerns across the Biosciences sector. However, deeper analysis revealed potential benefits in specific patient subgroups, offering a renewed Biosciences opportunity.
New Clinical and Regulatory Approach
KBP Biosciences is now adopting a more targeted approach. By focusing on patient populations that showed favorable responses, the Biosciences firm aims to improve trial outcomes. Additionally, updated regulatory strategies could help accelerate approvals within the competitive Biosciences landscape.
If successful, this move could significantly impact the cardiovascular segment of the Biosciences market. With heart disease remaining a leading global health issue, a revived therapy could position KBP Biosciences as a key player in the Biosciences industry once again.
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