Novo sheds kidney drug licensed for $1.3bn a year ago

 Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.

The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.

In its announcement of the deal, Novo said it was an important deal to advance its strategy of "expanding from our core in diabetes into other serious chronic diseases."

The deal was signed when there were high hopes for the results of an ongoing phase 3 trial – CLARION-CKD – which was testing ocedurenone as a treatment for uncontrolled hypertension in patients with advanced CKD.

Prospects were dashed earlier this year, however, when the study missed its primary endpoint, with the drug failing to achieve a significant reduction in blood pressure.

At the time, Novo said it was evaluating oceduronone's potential in other indications, having previously suggested it was considering additional phase 3 trials in other cardiovascular and kidney disease settings.

News of the demise of ocedurenone came in the company's third-quarter results update, in which it said that, "based on the interim analysis in June, Novo Nordisk has further analysed detailed trial data and decided to terminate further development of ocedurenone." It took a DKK 5.7 billion ($822 million) write-off charge in the period in connection with the decision.

Uncontrolled hypertension is a leading risk factor for cardiovascular events, heart failure, CKD, and premature death, so ocedurenone could have slotted perfectly alongside Novo's semaglutide-based products, which are approved for diabetes, obesity, and cardiovascular risk reduction.

Earlier this year, the company also reported positive results from the FLOW trial of semaglutide in patients with type 2 diabetes and CKD, showing that it slashed the risk of major cardiovascular events by 18% and all-cause mortality by 20%, which it said set up regulatory filings in the US and Europe before the end of this year.

While a disappointment, the announcement came alongside a buoyant set of financial results for Novo, with third-quarter sales of semaglutide-based obesity therapy Wegovy rising 79% to nearly $2.5 billion after a worrying slowdown in the second quarter.

https://pharmaphorum.com/news/novo-sheds-kidney-drug-licensed-13bn-year-ago