Sanofi says NOTUS data confirm positive Phase 3 BOREAS study

Sanofi said late-breaking data were presented from the NOTUS Phase 3 study evaluating the investigational use of Dupixent as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease on maximal standard-of-care inhaled therapy and evidence of type 2 inflammation. The NOTUS study confirmed the positive results demonstrated in the Phase 3 BOREAS study, with its data presented at a late-breaking session of the 2024 American Thoracic Society International Conference and simultaneously published in the New England Journal of Medicine, the company announced in a statement. The NOTUS study met its primary and key secondary endpoints. All patients were on background maximal standard-of-care inhaled therapy. Patients receiving Dupixent experienced the following, compared to placebo: 34% reduction in moderate or severe COPD exacerbations over 52 weeks, the primary endpoint; More than two times greater improvement in lung function from baseline at 12 weeks, with an improvement maintained at week 52, secondary endpoints; Numerically greater improvements in health-related quality of life from baseline at 52 weeks, a secondary endpoint, as defined by patient-reported outcomes in the St. George’s Respiratory Questionnaire. — Numerically greater reductions in respiratory symptom severity from baseline to 52 weeks, a secondary endpoint, as defined by PROs in Evaluating Respiratory Symptoms in COPD (E-RS).