Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

Dive Brief:

• Novo Nordisk will end a Phase 3 clinical trial of a hypertension drug it bought for up to $1.3 billion last year because treatment didn’t appear to be working, the company said Wednesday.
• The decision was based on an interim data analysis by study monitors, which revealed the drug, called ocedurenone, met the trial’s “futility criteria,” indicating treated participants didn’t experience a greater drop in blood pressure than those given placebo.
• The company will take an accounting charge of 5.7 billion Danish kroner, or about $817 million, on its second quarter earnings to offset the loss of valuation represented by ocedurenone. The charge will lower Novo’s operating profit guidance by 6 percentage points from the 22% to 30% it forecast in May.

Dive Insight:

Novo bought ocedurenone from Singapore-based KBP Biosciences, one of a string of acquisitions made as it seeks to put profits from its diabetes and obesity drugs Ozempic and Wegovy to work.

When Novo announced the deal, KBP had already begun a Phase 3 trial of ocedurenone in people with chronic kidney disease and hypertension that couldn’t be controlled with at least two medications. Results from a Phase 2 study of 162 people had shown ocedurenone lowered blood pressure in that population by 10 points more than a placebo.

The larger Phase 3 study, intended to confirm the earlier findings, enrolled 652. The decision to terminate the trial was based on an interim analysis investigators set up before it began, which involved measuring blood pressure after 12 weeks of treatment for a difference between study volunteers taking ocedurenone and those on placebo.

Had the drug shown signs of benefit at 12 weeks, the study would have evaluated blood pressure again between 48 and 52 weeks to determine how well it worked.

Novo said it is still evaluating next steps for ocedurenone in other indications. When the two companies agreed on the deal, Novo executives had said they intended to initiate Phase 3 trials in cardiovascular disease and other kidney disease settings.

People with chronic kidney disease and hypertension often take multiple drugs to lower blood pressure, including medicines called angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers or beta blockers. Ocedurenone is a type of diuretic called a mineralocorticoid receptor antagonist — a similar mechanism of action to Bayer’s recently approved Kerendia.