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Sanofi And Regeneron To Consult Regulators After Mixed Phase 3 COPD Results For Itepekimab, As AERIFY-1 Meets Primary Endpoint And AERIFY-2 Falls Short

Benzinga·05/30/2025 06:03:27
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  • AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit
  • AERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite a benefit seen earlier in the study
  • Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2
  • Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate next steps