Sanofi and Regeneron have unveiled top-line data showing that two late-stage studies of Dupixent in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP) met all their primary and secondary endpoints.
On the co-primary endpoints for both trials at 24 weeks, patients treated with Dupixent (dupilumab) added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to 15% and 19% improvement with nasal spray alone.
Data also showed that Dupixent-treated patients had a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo.
The firms said all secondary endpoints were met, including showing a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms.
Also of note, in a pre-specified group of patients with comorbid asthma, Dupixent significantly improved lung function and asthma control.
“Dupixent has now demonstrated significant late-stage efficacy in three Type 2 or allergic inflammatory diseases, indicating that IL-4 and IL-13 are required drivers of Type 2 or allergic inflammation in general. With these data, Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma,” said George Yancopoulos, president and chief scientific officer of Regeneron.
“We look forward to US regulatory action on our moderate-to-severe asthma application later this month, and are continuing our development program in additional Type 2 or allergic inflammatory diseases with high unmet need including pediatric asthma, pediatric and adolescent atopic dermatitis, eosinophilic esophagitis, and food and environmental allergies.”
CRSwNP is a chronic disease in which Type 2 or allergic inflammation causes polyps that obstruct the sinus and nasal passages, leading to severe congestion, nasal discharge, facial pain or pressure, and reduced sense of smell and taste.