Two phase III trials of Dupixent in chronic rhinosinusitis meet primary endpoints-. Sanofi.

Two pivotal Phase III placebo-controlled trials evaluating Dupixent (dupilumab), from Sanofi, in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps ("CRSwNP") met all primary and secondary endpoints. 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). Dupixent also met all secondary endpoints in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms. In a pre-specified group of patients with comorbid asthma, Dupixent significantly improved lung function and asthma control (p < 0.0001 for all primary and secondary endpoints in both trials). Dupixent blocks the IL-4 and IL-13 signaling pathways.

The rates of adverse events were generally similar across Dupixent and placebo, and no new or unexpected side effects related to Dupixent were observed. The rates of conjunctivitis were: 1.4 percent Dupixent versus 0.8 percent placebo in SINUS-24; 2.7 percent Dupixent every two weeks and 2.0 percent Dupixent every two/four weeks versus 1.3 percent placebo in SINUS-52. Detailed results from these trials will be submitted for presentation at future medical meetings, and will form part of the companies' regulatory submissions.