Sanofi and Regeneron's Phase 3 dupilumab sees positive top-line results.
M2 PHARMA-September 11, 2017-Sanofi and Regeneron's Phase 3 dupilumab sees positive top-line results
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Sanofi (EPA: SAN) and Regeneron's (NASDAQ: REGN) Phase 3 LIBERTY ASTHMA QUEST study investigating dupilumab in a wide population of patients with uncontrolled, persistent asthma has met its two primary endpoints, the companies announced on Monday.
When added to standard therapies, the drug reduced severe asthma attacks and improved lung function.
The Phase 3 trial involved 1,902 patients -- 1,795 adults and 107 adolescents -- and was conducted at 413 study sites across the globe. It was made up of four study groups, with patients treated with 200mg every other week with a loading dose of 400mg; 300mg every other week with a loading dose of 600mg; and two separate placebo groups. Patients were randomised 2:1 to active drug versus placebo.
At the end of the study (52 weeks) dupilumab reduced severe asthma attacks by 46% in the 300mg dose group, 60% in patients with 150 eosinophilic cells/microliter or greater, and 67% in patients with 300 eosinophilic cells/microliter or greater.
The companies plan to submit a Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) by the end of 2017.
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