Incyte has announced that the Phase III RUXCOVID study of JAK1 / JAK2 inhibitor ruxolitinib (Jakafi) for treating patients aged 12 years and above with Covid-19-associated cytokine storm did not meet its primary endpoint.
Cytokine storm is a severe immune overreaction due to viral infection. It can lead to serious complications such as pneumonia and acute respiratory distress syndrome (ARDS).
Incyte sponsored the study in the US while Novartis funded those outside of the country.
The global, randomised, double-blind, placebo-controlled, 29-day, multi-centre study analysed the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy in patients with Covid-19-associated cytokine storm compared to placebo plus SoC therapy.
The trial enrolled 432 patients worldwide who were randomised 2:1 to receive oral ruxolitinib 5mg twice daily or placebo for a total of 14 days along with SoC.
If clinical signs or symptoms did not improve or worsen, and the potential benefit outweighed the potential risks after 14 days of treatment, patients could receive an additional study therapy for 14 days.
Initial results showed no reduction in the number of patients receiving ruxolitinib plus SoC who experienced severe complications, including death, respiratory failure needing mechanical ventilation or admission to the intensive care unit (ICU) care, by day 29 versus SoC treatment alone.
Moreover, no clinically significant benefit of the treatment was observed among secondary and exploratory endpoints, including mortality rate by day 29 and time to recovery.
Incyte chief medical officer Steven Stein said: “Given the urgent nature of the Covid-19 pandemic and the need for treatments for patients hospitalised with severe Covid-19-associated cytokine storm, the results of the RUXCOVID study are disappointing.
“However, we hope that these findings will contribute to the scientific understanding of this complex disease and to the collective efforts of the biopharma industry to find solutions that improve outcomes for patients with Covid-19.”
In April, Incyte started a Phase III trial of ruxolitinib to treat cytokine storm caused by the Covid-19 coronavirus infection.