Novartis’ Ilaris Fails to Meet Endpoints in COVID-19 Study

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Novartis’ Ilaris (canakinumab), an IL-1β inhibitor, came up short in a Phase III COVID-19 study, the company reported, following an interim analysis of data.

This morning, the Swiss pharma giant announced Ilaris plus standard of care did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus the standard of care. Ilaris also failed to meet the key secondary endpoint of reducing mortality in COVID-19 patients, Novartis said.

In the trial, the primary endpoint of survival without the need for mechanical ventilation was 88.8% for Ilaris plus standard of care compared to 85.7% for placebo and standard of care. The key secondary endpoint of COVID-19-related mortality up to four weeks was 4.9% for Ilaris and standard of care compared to 7.2% for placebo. Both the primary and key secondary endpoints trended in favor of canakinumab but did not reach statistical significance.

John Tsai, head of Global Drug Development and chief medical officer for Novartis, said that although the Phase III CAN-COVID trial failed to meet endpoints, it did improve the scientific understanding of COVID-19 and the role of interleukin-1β inhibition.

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