Regeneron and Sanofi announced that their Phase 3 study of dupilumab met its primary endpoints of reducing severe asthma attacks and improving lung function when added to standard therapies in patients with uncontrolled, persistent asthma.
Dupilumab is a fully human monoclonal antibody designed to simultaneously inhibit overactive signaling of IL-4 and IL-13 cytokines and was approved earlier this year to treat moderate-to-severe atopic dermatitis. The QUEST study enrolled 1,902 asthma patients who were randomized to four groups: 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.
Results showed that at 52 weeks severe asthma attacks in the 300mg dose group were reduced by 46% in the overall population and by 60% and 67% among those patients with ≥150 eosinophilic cells/microliter and ≥300 eosinophilic cells/microliter, respectively (P<0.001).
Mean improvement in lung function in the 300mg group, assessed by forced expiratory volume over one second (FEV1), was 130mL (9%) in the overall population, 210mL (11%) in patients with ≥150 eosinophilic cells/microliter, and 240mL (18%) in patients with ≥300 eosinophilic cells/microliter (P<0.001 for all groups) at 12 weeks.
“We believe that therapies like dupilumab, which focus on specific molecular pathways such as the Th2 pathway associated with multiple chronic allergic diseases, are important targets for further investigations,” said Elias Zerhouni MD, President of Global R&D, Sanofi. “We will work diligently with health authorities to bring this new application of dupilumab to the patients who most need it.”
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
For more information visit Regeneron.com.