Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a Danish pharmaceutical company, has announced that its pipeline candidate ocedurenone has failed in a Phase III trial for chronic kidney disease (CKD). The drug did not meet the primary endpoint in the CLARION-CKD study, leading to the cancellation of its development for CKD. The company is currently evaluating whether to continue trials for other indications.
According to a press release, the setback will result in an impairment loss of approximately DKK 5.7 billion (USD 817 million), which will be reflected in the forthcoming financial report. Novo Nordisk estimates this will have a negative impact of 6 percentage points on the operating profit growth for 2024.
Ocedurenone, a third-generation non-steroidal mineralocorticoid receptor antagonist (MRA), was designed with a unique pharmacokinetic profile, offering a relatively long half-life and high mineralocorticoid receptor (MR) affinity compared to existing drugs. The trial involved 652 patients, but an interim analysis at the 12-week mark indicated that the drug met the trial’s “futility criteria,” signifying that there was no significant difference in blood pressure reduction between the drug and placebo groups.
Novo Nordisk acquired ocedurenone from Singapore-based KBP Biosciences PTE Ltd in October 2023 when the molecule was already in the CLARION-CKD trial. The acquisition was valued up to USD 1.3 billion, with specific terms undisclosed. At that time, Novo Nordisk planned to initiate Phase III trials for cardiovascular disease and other kidney disease settings. However, the company has stated that further development of ocedurenone for these other indications is now under evaluation.- Flcube.com
