Dupixent shows Phase III promise for chronic rhinosinusitis patients

Two pivotal Phase III placebo-controlled trials evaluating Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP) met all primary and secondary endpoints.

The drug is marketed by French pharma major Sanofi (Euronext: SAN), which acquired rights to the biologic from its US developer Regeneron (Nasdaq: REGN). It is approved in numerous countries to treat dermatitis and generated sales of 176 million euros ($204 million) in the second quarter of this year, compared to 26 million euros in the like quarter of 2017.

On the co-primary endpoints for both trials at 24 weeks, patients treated with Dupixent 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 (placebo) (-1.25 and -1.34 for Dupixent compared to -0.38 and -0.45 for placebo, on a 0-3 scale ). Dupixent treated patients had  a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy).