Regeneron, Sanofi report Dupixent trial meets primary and secondary endpoints

Regeneron (REGN) and Sanofi (SNY) announced the primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease, or COPD, and evidence of type 2 inflammation. Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction in moderate or severe acute exacerbations of COPD over 52 weeks, while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms. In the BOREAS trial, 939 adults who were current or former smokers aged 40 to 80 years were randomized to receive Dupixent or placebo added to maximal standard-of-care inhaled therapy. Patients receiving Dupixent experienced: 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks, the primary endpoint. Improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo, with the benefit versus placebo sustained through week 52, both of which were key secondary endpoints. Dupixent met all endpoints tested in the hierarchy, including improvement in patient-reported health-related quality of life as measured by the St. George’s Respiratory Questionnaire and reduction in the severity of respiratory symptoms of COPD as measured by Evaluation Respiratory Symptoms: COPD Scale. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events were 77% for Dupixent and 76% for placebo. AEs more commonly observed with Dupixent compared to placebo included headache, diarrhea and back pain. AEs more commonly observed with placebo compared to Dupixent included upper respiratory tract infection, hypertension and COVID-19. AEs leading to deaths were balanced between the two arms. Detailed efficacy and safety results from this trial will be presented in a future scientific forum. The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33, or IL-33. Itepekimab received Fast Track Designation from the FDA in January 2023 for the treatment of COPD in patients who do not currently smoke. Data from this program is expected in 2025. The safety and efficacy of Dupixent and itepekimab in COPD have not been fully evaluated by any regulatory authority.