Novo Nordisk has said it will take a DKr5.7bn ($816m) hit after its acquired drug ocedurenone flopped in the Phase III trial.
The Phase III CLARION-CKD trial (NCT04968184) failed to meet its primary endpoint in patients with uncontrolled hypertension and moderate or severe (stage 3b/4) chronic kidney disease (CKD).
The drug was acquired by the Danish pharma giant from KBP Biosciences last year in a $1.3bn deal. At the time of the acquisition, KBP Biosciences was already conducting the Phase III study.
The company said that following the trial data, it recognises an impairment loss of $816m related to ocedurenone in Q2 2024.
The trial design included a prespecified interim analysis by an independent data monitoring committee after 12 weeks of treatment. The analysis showed that the trial had not met its primary endpoint of change in systolic blood pressure (SBP), leading Novo to terminate the study.
The trial was estimated to enrol approximately 600 patients from 150 sites in the US, Europe, and Asia, with the first patient dosed at the end of 2021.
Novo had also announced plans to investigate the candidate in other cardiovascular and kidney disease indications in the coming years. Novo has announced it is now evaluating the further development of ocedurenone.
Kajal Jaddoo, senior pharma analyst at GlobalData, said: “CKD clinical trials have very broad and complex primary endpoints that need to be met. Several promising CKD drug candidates failed to meet their endpoints in late-stage trials in recent years, which is a huge economic burden to pharmaceutical companies pursuing kidney disease drug discovery and a huge disappointment to patients.
“Trial issues may cause pharmaceutical companies to switch their investments to more profitable disease areas, which will have a negative impact on the production of new CKD medications on the global market.”
Ocedurenone is a non-steroidal, mineralocorticoid receptor antagonist that blocks the binding of aldosterone. Aldosterone binds to mineralocorticoid receptors in both epithelial and non-epithelial tissues, as well as increases blood pressure and kidney disease through induction of sodium reabsorption and possibly other mechanisms.
The Phase IIb trial (NCT03574363) of the candidate, also run by KBP Biosciences ahead of the acquisition, met its primary endpoint with ocedurenone demonstrating a clinically meaningful and statistically significant improvement in SBP in the same patient population.
Novo Nordisk has a market cap of $499bn, according to GlobalData’s Pharmaceutical Intelligence Center.
GlobalData is the parent company of the Clinical Trials Arena.
