Ocedurenone is currently being evaluated in the phase 3 CLARION-CKD trial in patients with uncontrolled hypertension and advanced chronic kidney disease

Novo Nordisk

Novo Nordisk’s finished products assembly pack. (Credit: Novo Nordisk A/S)

Novo Nordisk has agreed to acquire ocedurenone, a drug for uncontrolled hypertension with potential application in cardiovascular and kidney disease, from US-based KBP Biosciences for up to $1.3bn.

Ocedurenone is an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist (nsMRA).

It is currently being evaluated in the phase 3 CLARION-CKD trial in patients with uncontrolled hypertension and advanced chronic kidney disease (CKD).

Novo Nordisk executive vice president and development head Martin Lange said: “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating uncontrolled hypertension and could help address a major unmet medical need in people living with cardiovascular disease and chronic kidney disease.”

To date, the hypertension drug has been assessed in nine clinical trials, including the BLOCK-CKD phase 2b trial.

It met its primary endpoint with ocedurenone showing a statistically significant and clinically meaningful improvement in systolic blood pressure (SBP) from baseline to day 84 in patients with stage 3b/4 CKD and uncontrolled hypertension.

Over 600 patients are anticipated to be randomly assigned by more than 150 locations in the CLARION-CKD late-stage trial.

It was launched in the US, Europe, and Asia with the first patient dosed at the end of 2021.

To maximise the potential of ocedurenone, Novo Nordisk anticipates starting phase 3 trials in the upcoming years for other cardiovascular and kidney disease indications.

KBP Biosciences founder and chairman Zhenhua Huang said: “We are delighted to pass the ocedurenone torch to Novo Nordisk, a global leader in the management of chronic diseases.

“We believe this transition could unlock the full potential of ocedurenone and benefit more patients with cardiovascular and kidney disease worldwide.”

The transaction is anticipated to close by the end of 2023, subject to receipt of all necessary regulatory clearances and other customary circumstances.

The deal will not affect Novo Nordisk’s existing share buyback programme or its previously disclosed operational profit outlook for 2023. The acquisition will be paid for by financial reserves held by Novo Nordisk.

Goodwin Procter represented KBP Biosciences and Covington & Burling represented Novo Nordisk in the transaction.