Regeneron, Sanofi announce presentation of Dupixent Phase 3 data in CSU

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) will present data from the Phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent in biologic-naive patients with uncontrolled chronic spontaneous urticaria who receive background therapy with antihistamines. Results showed treatment with Dupixent significantly reduced itch and urticaria activity scores from baseline, and a higher proportion of patients achieved well-controlled disease status compared to placebo. The data are being shared in a late-breaking oral presentation at the American College of Allergy, Asthma & Immunology 2024 Annual Scientific Meeting in Boston, Massachusetts. Study C enrolled 151 children and adults who were randomized to receive Dupixent or placebo added to standard-of-care histamine-1 antihistamines. At 24 weeks, Dupixent demonstrated significant improvements compared to placebo on: Itch severity score; Urticaria activity score; Well-controlled disease status; Complete response. The safety results in Study C were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment emergent adverse events were 53% for both Dupixent and placebo. AEs more commonly observed with Dupixent compared to placebo included injection site reactions, accidental overdose and COVID-19 infection. Dupixent has been approved for CSU in Japan and the United Arab Emirates and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.