Incyte says Phase III Jakafi trial misses endpoint for COVID-1-associated ARDS

Marking a second disappointment for Incyte (Nasdaq: INCY) in the novel coronavirus setting, the company announced results from the Phase III DEVENT study evaluating the efficacy and safety of Jakafi (ruxolitinib) 5mg and 15mg plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.

Incyte’s shares closed down 2.4% at $78.25 on Thursday.

While results indicate a trend towards an improvement in mortality in the overall study population (N=211), the DEVENT study did not meet its primary endpoint - mortality due to any cause through day 29 - adjusted for ARDS severity between the two treatment arms versus placebo (55.2% versus 74.3% [Odds Ratio (OR): 0.42 (95% CI: 0.171-1.023)], P=0.0280 in the 5mg arm and 51.8% vs 69.6% [OR: 0.46 (95% CI: 0.201-1.028)], P=0.0292 in the 15mg arm).