Novo Halts $1.3B Blood Pressure Drug Trial

Novo Nordisk has decided to discontinue its Phase 3 clinical trial for the hypertension medication ocedurenone, which it acquired for up to $1.3 billion last year. This decision follows an interim analysis by study monitors that indicated the drug did not demonstrate better efficacy in lowering blood pressure compared to a placebo.

The interim analysis led to the conclusion that ocedurenone met the trial's futility criteria, meaning the treatment did not result in a significant reduction in blood pressure among participants. As a result of this outcome, Novo Nordisk will record an accounting charge of approximately $817 million (5.7 billion Danish kroner) in its second-quarter earnings. This charge is expected to reduce Novo's operating profit guidance by 6 percentage points from the previously forecasted range of 22% to 30%.

Novo Nordisk had purchased ocedurenone from Singapore-based KBP Biosciences, as part of a series of acquisitions aimed at utilizing profits from its successful diabetes and obesity drugs, Ozempic and Wegovy. At the time of the acquisition, KBP had already initiated a Phase 3 trial of ocedurenone in patients with chronic kidney disease and hypertension that could not be controlled with at least two other medications. Results from a Phase 2 study involving 162 participants had shown that ocedurenone could lower blood pressure by 10 points more than a placebo in this patient population.

The larger Phase 3 study, which sought to confirm these earlier findings, included 652 participants. The decision to end the trial was based on a pre-planned interim analysis that assessed blood pressure differences after 12 weeks of treatment between those receiving ocedurenone and those on placebo. If the interim results had indicated potential benefits, the study would have continued to evaluate blood pressure at 48 to 52 weeks to further determine the drug's efficacy.

Despite halting the trial, Novo Nordisk is still considering next steps for ocedurenone in other medical indications. When the acquisition deal was first announced, Novo executives had expressed intentions to initiate Phase 3 trials for ocedurenone in cardiovascular disease and other kidney disease contexts.

Patients with chronic kidney disease and hypertension often require a combination of medications to manage their condition. These can include angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, or beta blockers. Ocedurenone is classified as a mineralocorticoid receptor antagonist, a type of diuretic which operates through a similar mechanism of action as Bayer's recently approved drug, Kerendia.

Novo Nordisk's decision to discontinue the trial underscores the challenges pharmaceutical companies face in bringing new treatments to market, particularly in complex conditions like hypertension and chronic kidney disease. The company's plans to explore other potential uses for ocedurenone indicate a continued commitment to addressing unmet needs in these areas.

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!