Incyte Announces Results of Phase 3 RUXCOVID Study of Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Cytokine Storm

Excerpt from the Press Release:

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi^®), a JAK1/JAK2 inhibitor, plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared to SoC treatment alone (12.0% vs. 11.8% [OR: 0.91 [95% CI: 0.48-1.73], P=0.769, respectively)¹.

In addition, there was no clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery, defined as the first day a patient met the criteria for category 0 (Uninfected – No clinical or virological evidence of infection), 1 (Ambulatory – No limitation of activities), or 2 (Ambulatory – Limitation of activities) on the 9-point ordinal scale¹. Ruxolitinib was generally well tolerated and no significant safety concerns were identified¹. A comprehensive analysis including safety data is ongoing. The results of this study do not affect other ongoing non-COVID-19 related ruxolitinib clinical trials or approved uses of ruxolitinib.

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