Press Release: Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD

Core Insights - Sanofi has made significant advancements in its respiratory pipeline, particularly with the drug amlitelimab for asthma, showing promising preliminary phase 2 results [1][2][3] Group 1: Amlitelimab in Asthma - The TIDE-Asthma phase 2 study revealed that while the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose, there were nominally significant reductions in asthma exacerbations at medium and low doses [2] - Amlitelimab demonstrated a more than 70% reduction in exacerbations in a biomarker-defined patient subgroup, indicating its potential to address unmet needs in asthma treatment [2][3] - The treatment regimen involved administration every four weeks for the first 24 weeks, followed by every 12 weeks, supporting a quarterly maintenance dosing schedule [3][11] Group 2: Future Clinical Studies - A phase 3 program for amlitelimab is currently being planned, with full results from the TIDE-Asthma study to be presented at an upcoming medical meeting [2][4] - Sanofi is also exploring lunsekimig in chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis, with phase 2 study results anticipated in 2026 [5][6] - Itepekimab is expanding its clinical studies into chronic rhinosinusitis and bronchiectasis, with phase 3 readouts expected in H2 2025 [7][9][8] Group 3: Mechanism of Action and Safety Profile - Amlitelimab operates through a unique non-depleting mechanism targeting OX40-Ligand, aiming to restore immune balance with infrequent dosing [3][10] - The safety profile of amlitelimab was consistent with previous studies, with no new safety signals identified, and treatment emergent adverse effects were similar between amlitelimab and placebo groups [3][11]