PARIS (dpa-AFX) - French drug giant Sanofi SA (SNYNF, SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Monday that the pivotal Phase 3 LIBERTY ASTHMA QUEST study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints.
The companies noted that investigational dupilumab, when added to standard therapies, reduced severe asthma attacks and improved lung function.
The companies plan to submit a Supplemental Biologics License Application or sBLA to the U.S. Food and Drug Administration by the end of this year.
The QUEST pivotal Phase 3 trial enrolled 1,902 patients including 1,795 adults and 107 adolescents across 413 study sites worldwide. The four study groups included patients treated with 200 mg every other week with a loading dose of 400 mg, 300 mg every other week with a loading dose of 600 mg, and two separate placebo groups.
The two primary endpoints of the study were the annualized rate of severe exacerbation events at 52 weeks and the absolute change from baseline in a standard measure of lung function known as pre-bronchodilator forced expiratory volume over one second at 12 weeks.
The overall rates of adverse events, deaths, infections, conjunctivitis, herpes and discontinuations were comparable between the dupilumab and placebo groups.
George Yancopoulos, President and Chief Scientific Officer of Regeneron, said, 'Dupilumab has now demonstrated positive late-stage results in two serious allergic diseases -- asthma and atopic dermatitis -- with robust efficacy and an extensive safety database. These results continue to support our hypothesis that the IL4/IL13 pathway is a critical driver of allergic disease, and weremain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases.'
Detailed results from this study will be submitted for presentation at a future medical congress.
In March 2017, the FDA approved Dupixent (dupilumab) in the U.S. for the treatment of moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies.
Copyright RTT News/dpa-AFX