Novartis’ canakinumab fails to meet primary endpoint in CAN-COVID trial

CAN-COVID is a randomised, double-blind and placebo-controlled study designed to evaluate the efficacy and safety of canakinumab plus standard of care (SoC) in hospitalised patients with Covid-19 pneumonia and cytokine release syndrome (CRS).

The interim analysis of the ongoing trial has demonstrated that that treatment with canakinumab plus standard of care (SoC) did not show a significantly greater chance of survival for patients without the requirement for invasive mechanical ventilation compared with placebo plus SoC up to day 29.

Novartis trial has also failed to achieve its crucial secondary endpoint of decreasing the Covid-19-related death rate during the fourth-week period after treatment.

The primary endpoint of survival without the requirement for mechanical ventilation was 88.8% for canakinumab plus SoC versus 85.7% for placebo plus SoC, while the key secondary endpoint of Covid-19-realted mortality up to four weeks was 4.9% for canakinumab plus SoC versus 7.2% for placebo plus SoC.

Novartis had recruited 454 patients at multiple centres across the US, Russia and Europe. With full results expected in early 2021, the trial is ongoing and continues for up to day 127.

Canakinumab, a monoclonal antibody, binds to and neutralises interleukin-1 beta (IL-1β) to block its action.

It is approved under the trade name Ilaris in around 60 countries, including the US, Europe and others. Canakinumab is designated for rare conditions, including periodic fever syndromes, adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA).

In April this year, Novartis first announced plans to begin a phase III clinical study to evaluate canakinumab, an interleukin (IL)-1β blocker, in patients with Covid-19 pneumonia.

Novartis global drug development head and chief medical officer Dr John Tsai said: “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.

“There’s still an urgent need for effective ways to combat Covid-19 and we will continue to apply our best scientific minds in support of the global pandemic response, including a Phase III trial of ruxolitinib.”