Incyte and Novartis announced a Phase III study of Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, failed to hit endpoints as a treatment for patients 12 and up with COVID-19 associated cytokine storm.
This morning, the two companies said treatment with the JAK inhibitor plus standard-of-care (SoC) in the late-stage RUXCOVID study did not prevent complications in patients with COVID-19 associated cytokine storm. There was no reduction in severe complications, including the need for mechanical ventilation and death. In the trial, the proportion of patients who died, or required mechanical ventilation due to respiratory failure or ICU care by Day 29, was 12% for Jakafi and SoC compared to 11.8% for placebo plus SoC.
Additionally, Novartis and Incyte said Jakafi and standard-of-care treatment failed to show a clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery.
Incyte and Novartis initiated their Jakafi study in the spring, when COVID-19 was running rampant across parts of Europe and Asia, and was also in its early days of outbreak in the United States. The companies said they intend to conduct a comprehensive analysis of the Phase III RUXCOVID study.
John Tsai, Novartis’ CMO and Global Head of Drug Development, also expressed his disappointment in the study’s failure.