Novo Nordisk has agreed to acquire ocedurenone for uncontrolled hypertension from KBP Biosciences for up to USD 1.3 billion.
“Hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death,” says Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “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.”
Ocedurenone is an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that is currently being examined in the phase 3 trial CLARION-CKD in patients with uncontrolled hypertension and advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments.
To date, ocedurenone has been investigated in nine clinical trials including the BLOCK-CKD Phase 2b trial. The BLOCK-CKD trial met its primary endpoint with ocedurenone demonstrating a clinically meaningful and statistically significant improvement in systolic blood pressure (SBP) from baseline to day 84 in patients with stage 3b/4 CKD and uncontrolled hypertension. There were no reports of severe hyperkalemia or acute kidney injury with ocedurenone in the trial1.
The CLARION-CKD phase 3 trial has been initiated in the US, Europe and Asia with the first patient dosed at the end of 2021 and will continue as planned with a total of more than 600 patients expected to be randomised by more than 150 sites. Novo Nordisk expects to initiate phase 3 trials in additional cardiovascular and kidney disease indications in the coming years, aiming to maximise the full potential of ocedurenone.
Photo of Martin Holst Lange: Novo Nordisk