Sanofi Announces Mixed Results from Phase 3 Studies of Itepekimab for COPD Treatment

Reuters
2025.05.30 05:00
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Sanofi SA has reported mixed results from its phase 3 studies of itepekimab for treating chronic obstructive pulmonary disease (COPD) in former smokers. The AERIFY-1 study achieved its primary endpoint with a significant reduction in exacerbations, while the AERIFY-2 study did not meet its primary endpoint despite some earlier benefits. Itepekimab was well tolerated in both studies. Sanofi, in collaboration with Regeneron, is evaluating the data and plans to discuss results with regulatory authorities. The drug is also being assessed for other conditions, including chronic rhinosinusitis and bronchiectasis.

Sanofi SA has announced the results of its phase 3 studies evaluating itepekimab for the treatment of chronic obstructive pulmonary disease (COPD) in former smokers. The AERIFY-1 study met its primary endpoint by demonstrating a statistically significant reduction in moderate or severe exacerbations, offering a clinically meaningful benefit. However, the AERIFY-2 study did not meet its primary endpoint despite showing some benefits earlier in the trial. Itepekimab was generally well tolerated in both studies, with comparable rates of adverse events between the treatment and placebo groups. Sanofi, in collaboration with Regeneron, is currently assessing the data and plans to discuss the results with regulatory authorities to determine the next steps. Additionally, itepekimab is being evaluated for other conditions, including chronic rhinosinusitis with and without nasal polyps, and bronchiectasis.