Sanofi's Bispecific Scores Double Respiratory Phase 2 Wins but Flunks Eczema Study

Sanofi's amlitelimab showed preliminary phase 2 efficacy in moderate-to-severe asthma, with nominal significance at medium dose for annualized exacerbation rate and improvements in lung function and asthma control; over 70% exacerbation reduction in biomarker-defined subgroup (eosinophils ≥300 cells/ml and elevated neutrophils) at week 60.1 3 4

Itepekimab met primary endpoint in AERIFY-1 phase 3 COPD study with 27% reduction in moderate/severe exacerbations in former smokers at week 52, but failed in AERIFY-2 despite early benefit; well-tolerated overall, next steps under regulatory review.2 6 7

Amlitelimab failed highest dose primary endpoint in TIDE-Asthma phase 2 for severe exacerbations at week 48, though positive signals in subgroups and medium dose; phase 3 planning underway.1 3

Earlier phase 2b STREAM-AD results for amlitelimab in atopic dermatitis (eczema) were positive with sustained improvements, but recent context highlights respiratory focus over eczema setback implication.5

Lunsekimig and itepekimab advancing in chronic rhinosinusitis and COPD alongside asthma.1