A Phase 3 clinical trial, LIBERTY ASTHMA VENTURE, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NYSE:SNY) DUPIXENT (dupilumab) in adults and adolescents with severe steroid-dependent asthma met its primary endpoint and key secondary endpoints.
At week 24, dupilumab plus standard therapies statistically significantly reduced the use of maintenance oral corticosteroids by an average of 70% and a median of 100% compared 42% and 50%, respectively, for placebo (p<0.0001). In patients with baseline eosinophil counts at least 300 cells/microliter, the reductions were 80% and 100%, respectively, compared to placebo’s 43% and 50% (p=0.0001).
At week 24, patients receiving dupilumab experienced 59% fewer asthma attacks than placebo (overall population) while those with eosinophil counts at least 300 cells/microliter experienced 71% fewer attacks. Treatment with dupilumab also resulted in a 15% improvement in lung function in the overall population and a 25% improvement in patients with elevated eosinophil counts (at least 300 cells/microliter).
Dupilumab’s safety profile was consistent with earlier studies.
A U.S. marketing application is on tap this quarter. DUPIXENT is currently approved in the U.S. and EU for moderate-to-severe atopic dermatitis.