Regeneron, Sanofi announces presentation of Phase 3 trial of Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced the presentation of positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 trial evaluating the investigational use of Dupixent in adults and children aged 6 years and older with allergic fungal rhinosinusitis, AFRS. The trial demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion and nasal polyps compared to placebo. These are the Phase 3 results specifically in AFRS and will be shared today at the American College of Allergy, Asthma and Immunology, ACAAI, 2025 Annual Scientific Meeting. Primary Endpoint: Sinus opacification scores improved by 50.0% in the Dupixent group versus 9.8% in the placebo group at 52 weeks; a significant reduction in sinus opacification scores was also observed at 24 weeks. Secondary Endpoints: Patient-reported nasal congestion/obstruction improved by 66.7% in the Dupixent group versus 25.3% in the placebo group at 24 weeks, with continued improvement at 52 weeks to 80.6% in the Dupixent group compared to 11.1% in the placebo group. Nasal polyp size reduced by 60.8% in the Dupixent group compared to 15.2% in the placebo group at 24 weeks, with continued reduction of 62.5% in the Dupixent group compared to 3.6% in the placebo group up to 52 weeks. 92% lower risk of systemic corticosteroid use and/or in need of surgery in the Dupixent group compared to placebo over 52 weeks.