Novartis COVID-19 mAb fails to meet clinical trial endpoints

By The Science Advisory Board staff writers

Novartis has released new data from an interim analysis of its randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of canakinumab (Ilaris), a monoclonal antibody (mAb) in hospitalized patients with COVID-19.

The CAN-COVID trial failed to meet its primary endpoint showing that treatment with Ilaris plus standard of care did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation. The trial also did not meet the second endpoint of reducing the COVID-19-related death rate during the four-week period after treatment.

"Though the CAN-COVID trial did not show the patient benefit we were hoping for, it helps improve the scientific understanding of COVID-19 and the role of interleukin-1β inhibition," said Dr. John Tsai, head of global drug development and chief medical officer for Novartis.

Ilaris binds to and neutralizes interleukin-1 beta (IL-1β), blocking its action. As well as being studied in severe COVID-19, Ilaris is also being investigated for the treatment of a number of other diseases involving inflammation, including non-small cell lung cancer.

The company reports that they will submit the interim analysis to a peer-reviewed journal in the coming weeks.


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