DENMARK —Novo Nordisk has revealed that the CLARION-CKD phase 3 study has failed, resulting in a DKK 5.7 billion (US$816 million) loss due to the failure of ocedurenone, a potential therapeutic candidate.

Ocedurenone is a third-generation nonsteroidal mineralocorticoid receptor antagonist (MRA) with a distinct pharmacokinetic (PK) profile distinguished by a lengthy half-life and high mineralocorticoid receptor (MR) affinity.

Ocedurenone was being tested for treating uncontrolled hypertension in people with advanced chronic kidney disease (CKD).

The CLARION-CKD trial was a multicenter, double-blind, placebo-controlled, randomized phase 3 investigation to determine the efficacy of ocedurenone.

This large-scale experiment enrolled more than 600 patients at over 150 sites, using the same inclusion criteria as the successful phase 2b BLOCK-CKD study.

According to Novo Nordisk, the BLOCK-CKD study previously met its primary endpoint with clinical and statistical significance, raising hopes for similar results in the phase 3 trial.

Novo Nordisk purchased ocedurenone from KBP Biosciences PTE., Ltd. for US$1.3 billion in 2023, and KBP Biosciences conducted the CLARION-CKD trial.

The trial design included a predefined interim analysis after all participants had completed 12 weeks of treatment.

Based on this interim analysis, an independent data monitoring committee determined that the trial met the specified futility criteria.

This result indicated that the trial did not meet its primary endpoint of a change in systolic blood pressure from baseline to week twelve.

As a result, Novo Nordisk has chosen to stop the CLARION-CKD study, resulting in an impairment loss of about DKK 5.7 billion (US$816 million)  for the intangible asset ocedurenone in the second quarter of 2024.

This financial setback is expected to negatively impact the company’s operational profit growth at constant exchange rates (CER) in 2024 by 6 percentage points.

 This impact is in comparison to the operational profit outlook provided in Novo Nordisk’s financial report for the period January 1, 2024 to March 31, 2024 (Company Announcement No 35/2024).

Despite this setback, Novo Nordisk is committed to expanding its research and development efforts in other areas.

The corporation has underlined that innovation and scientific exploration continue to remain at the centre of its approach.

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