On Wednesday, Novo Nordisk A/S (NYSE:NVO) announced that the CLARION-CKD phase 3 trial failed to meet its primary endpoint.
CLARION-CKD was a multicenter, double-blind, placebo-controlled, randomized phase 3 study of ocedurenone for uncontrolled hypertension in patients with advanced chronic kidney disease (CKD).
CLARION-CKD follows the same inclusion criteria as the phase 2b BLOCK-CKD study, which achieved its primary endpoint with clinical and statistical significance. More than 600 patients were randomized for the CLARION-CKD trial.
Novo Nordisk acquired ocedurenone from KBP Biosciences PTE., Ltd. in 2023. KBP Biosciences conducted the phase 3 lead indication trial CLARION-CKD, which investigated ocedurenone in patients with uncontrolled hypertension and advanced chronic kidney disease.
The trial design included a prespecified interim analysis after all participants had completed 12 weeks of treatment.
Based on the interim analysis, an independent data monitoring committee concluded that the trial met the prespecified futility criteria—meaning that it did not meet its primary endpoint of change in systolic blood pressure from baseline to week 12. As a result, Novo Nordisk has decided to stop the CLARION-CKD trial.
The company will recognize an impairment loss of around 5.7 billion Danish kroner (around $817 million) related to the intangible asset ocedurenone in the second quarter of 2024.
This corresponds to an estimated negative impact of around six percentage points on operating profit growth at CER in 2024 compared to the operating profit outlook communicated in the financial report for the period 1 January 2024 to 31 March 2024.
Further development of ocedurenone in other indications is now being evaluated.
Ocedurenone is a third-generation, non-steroidal, mineralocorticoid receptor antagonist.
https://finance.yahoo.com/news/novo-nordisk-halts-stage-study-181012341.html
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