Sanofi and Regeneron weigh mixed trial results for itepekimab

30 May 2025

US biotech Regeneron (Nasdaq: REGN) and French drugmaker Sanofi (Euronext: SAN) are reviewing next steps for their experimental COPD therapy itepekimab following contrasting outcomes from two Phase III studies. The companies plan to discuss the results with regulatory agencies before determining the future of the interleukin (IL)-33 inhibitor.

The AERIFY-1 trial met its primary endpoint, showing a 27% reduction in moderate or severe exacerbations among former smokers treated with itepekimab every two weeks compared to placebo.

However, the parallel AERIFY-2 study did not achieve the same success. Reductions in exacerbation rates at 52 weeks - 2% and 12% for the respective dosing groups - were not statistically significant.

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