Novo nixes trial of blood pressure drug it bought in $1.3B deal – BioPharma Dive

Posted: Published on July 1st, 2024

This post was added by Dr Simmons

Dive Brief:

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 couldnt 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 drug called a nonsteroidal mineralocorticoid receptor antagonist a similar mechanism of action to Bayers recently approved Kerendia.

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Novo nixes trial of blood pressure drug it bought in $1.3B deal - BioPharma Dive

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