Breakthrough in COPD treatment

French Sanofi SA’s second Phase III trial of duplimab demonstrated a 34% reduction in exacerbations and significant lung function improvements.

Sanofi’s duplimab (Dupixent^®) showcased notable efficacy in reducing exacerbations and enhancing lung function in its second positive Phase III trial, affirming its potential as the first approved biologic for chronic obstructive pulmonary disease (COPD). The second investigational Phase III trial revealed a 34% reduction in exacerbations compared to placebo for patients with moderate-to-severe COPD and type 2 inflammation, aligning with the landmark first Phase III trial. Rapid lung function improvements were observed with  duplimab at 12 weeks, maintained through 52 weeks. Sanofi SA and Regeneron Pharmaceuticals Inc. plan to submit these promising findings to the FDA by year-end, aiming to expedite Dupixent’s availability for patients experiencing uncontrolled COPD, where no new treatments have emerged in over a decade.

“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two Phase III trials, and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” explains Naimish Patel, M.D., Head of Global Development, Immunology, and Inflammation at Sanofi. The FDA granted Breakthrough Therapy designation to Dupixent earlier in the year, further emphasising its significance in managing uncontrolled COPD associated with exacerbations and eosinophilic phenotype.

The trial involved 935 adults and demonstrated Dupixent’s superior performance over placebo, revealing a substantial reduction in exacerbations and significant lung function improvements. Safety outcomes align with Dupixent’s known profile, and detailed trial results are slated for presentation at scientific forums. Dupixent, already approved for various indications, has shown promising results in COPD, potentially benefiting patients globally. Its development programme continues to explore its potential across multiple chronic diseases driven by type 2 inflammation, aiming to offer new treatment avenues for those in need. “Our second programme in COPD, itepekimab, continues with data expected in 2025. If positive, Dupixent and itepekimab could emerge as treatments for approximately 80% of those suffering from moderate-to-severe COPD with recurrent exacerbations,” said Patel.