Novartis has announced that its arthritis drug, canakinumab, failed to meet its primary endpoint in Phase III CAN-COVID trial on hospitalised patients with Covid-19 pneumonia and cytokine release syndrome (CRS).
Canakinumab is a monoclonal antibody that attaches to and neutralises interleukin-1 beta (IL-1β), inhibiting its action.
The biologic medicine is used for treating periodic fever syndromes, adult-onset Still’s disease (AOSD), and systemic juvenile idiopathic arthritis (SJIA).
The ongoing multi-centre, randomised, double-blind, placebo-controlled trial is evaluating the efficacy and safety of canakinumab plus standard of care (SoC) in patients.
The trial is being conducted in multiple centres across the US, Russia and Europe, on 454 patients who were hypoxic but do not need intubation or invasive mechanical ventilation.
At day 29, treatment with canakinumab plus SoC did not show a significantly greater chance of survival for patients without the need for invasive mechanical ventilation as compared with placebo, subsequently failing to meet the trial’s primary endpoint.
Furthermore, the key secondary endpoint of reducing the Covid-19-related death rate during the four weeks after treatment was not met.
Novartis Drug Development global head and chief medical officer 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.”
Last month, Novartis entered a partnership with Molecular Partners to develop two DARPin therapies designed for potential use against Covid-19.
In April, Novartis devised plans to conduct a Phase III trial of canakinumab for the treatment of patients suffering from Covid-19 pneumonia.