Novartis’ arthritis drug canakinumab failed to hit its primary endpoint of improving survival for COVID-19 patients without the need for invasive mechanical ventilation, the Swiss pharma company announced today.
Novartis had been studying the drug in hospitalised patients with COVID-19 pneumonia and cytokine release syndrome (CRS).
The trial failed to show that treatment with canakinumab plus standard of care demonstrated a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with standard of care at day 29.
Canakinumab, which Novartis already sells under the brand name Ilaris, is a once-monthly biologic used to treat systemic juvenile idiopathic arthritis and active Still’s disease.
It is a monoclonal antibody designed to bind to and neutralise interleukin-1 beta (IL-1β). Excessive production of IL-1β plays a significant role in certain inflammatory diseases and immune responses.
A number of pharma companies had been aiming to repurpose their interleukin-6 inhibitors, normally used to treat autoimmune diseases, for the treatment of COVID-19.
Developers theorised that these drugs could have an impact on CRS, a form of systemic inflammatory response that can occur as a complication of some diseases and infections.
This includes Roche’s Actemra (tocilizumab) and Sanofi and Regeneron’s Kevzara (sarilumab), with both drugs entering clinical trials evaluating their efficacy in severely ill COVID-19 patients.
However, neither drug was successful. Actemra did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia in July, although researches did observe a positive trend in the time it took to discharge patients from hospital following treatment with the IL-6 inhibitor.
Kevzara was also unable to prevent death or help patients come off ventilation among mechanically ventilated patients. Again, researchers did observe a trend towards reduced mortality in the critical patient group, although this was not seen in the severe patient arm.
The fight against COVID-19 doesn’t stop with canakinumab for Novartis – in October, the company announced a collaboration with Molecular Partners for access to two anti-COVID-19 antivirals.
According to the Swiss pharma, the candidates – MP0420 and MP0423 – have the potential to prevent and treat COVID-19, with the further possibility of being manufactured at scale and could be able to bypass cold storage.
Novartis is also still conducting a phase 3 trial of its JAK1/2 inhibitor Jakavi (ruxolitinib) in COVID-19, with preliminary results from this study expect by the end of the year.
“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 3 trial of ruxolitinib,” said John Tsai, head of global drug development and chief medical officer for Novartis.