Sanofi advances respiratory pipeline with new asthma data and COPD study plans

Paris, April 15, 2025 – Sanofi announced advancements in its respiratory pipeline, presenting preliminary Phase 2 results for amlitelimab in adults with moderate-to-severe asthma. While the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose, the medium dose showed nominal significance. The study indicated amlitelimab's efficacy in heterogeneous inflammatory asthma, potentially offering a breakthrough for underserved patients. Treatment led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose and a numerically greater reduction at the high dose by week 60. Secondary endpoints for lung function and asthma control also showed nominal significance. In a subgroup defined by biomarkers (eosinophils ≥300 cells/ml and elevated neutrophils), amlitelimab demonstrated nominally significant and clinically meaningful improvements, reducing exacerbations by over 70% and improving lung function and control at week 60. Sanofi is now planning a Phase 3 program for amlitelimab. Sanofi is also expanding the investigative use of lunsekimig to include chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis. Itepekimig will be further explored in chronic rhinosinusitis, COPD, and bronchiectasis, with Phase 3 COPD readouts expected in the second half of 2025 and Phase 2 bronchiectasis results in 2026. Amlitelimab targets OX40-Ligand and has a mechanism aiming to restore immune balance. The Phase 2 study involved dosing every four weeks initially, then every 12 weeks. The sustained effect through 60 weeks supports a quarterly maintenance schedule. The drug's safety profile remained consistent with previous studies, with no new safety signals identified.