Sanofi's COPD Drug Itepekimab Meets Primary Endpoint in One of Two Phase 3 Studies

Paris and Tarrytown, NY – Sanofi reported on Friday that its investigational drug, itepekimab, successfully met the primary endpoint in one of two Phase 3 studies assessing its efficacy in former smokers with chronic obstructive pulmonary disease (COPD).

The AERIFY-1 study demonstrated a statistically significant reduction in moderate or severe exacerbations over 52 weeks compared to placebo. The reduction was 27 percent, which the company described as a clinically meaningful benefit. Sanofi and partner Regeneron are now assessing the data to discuss the next steps with regulatory authorities.

However, the AERIFY-2 study, the second Phase 3 trial, did not meet the same primary endpoint, although initial results indicated a benefit. In both studies, itepekimab was generally well tolerated when added to standard-of-care therapy, administered every two or four weeks.

The observed number of exacerbations was lower than prospectively anticipated in both trials, which reduced their statistical power. The enrollment period, largely overlapping with the COVID-19 pandemic, may have contributed to the overall lower exacerbation rates.

Sanofi and Regeneron are thoroughly reviewing the findings. The companies remain committed to seeking new treatment options for COPD patients, particularly those experiencing continued exacerbations despite maximal therapy. Itepekimab is also being investigated for other conditions, including chronic rhinosinusitis with nasal polyps.