Sanofi Advances Respiratory Pipeline with Amlitelimab, Lunsekimig, and Itepekimab
PARIS,15TH APRIL, 2025 – Sanofi today announced key advancements in its respiratory pipeline, highlighting positive phase 2 data for amlitelimab in asthma and expanding clinical development for lunsekimig and itepekimab into new indications, including COPD and chronic rhinosinusitis.
Amlitelimab has shown clinically meaningful reductions in asthma exacerbations, improved lung function, and a better degree of asthma control in patients who have been biomarker-defined as having elevated eosinophils and neutrophil counts.
Though the primary endpoint at the highest dose was not met, mid and low doses showed nominal significance, supporting a potential long-term, durable outcome of amlitelimab as an asthma therapy. A phase 3 program is being planned.
Amlitelimab targeting OX40-Ligand to restore immune balance showed sustained efficacy through 60 weeks, during which no new safety signals emerged and with less frequent dosing. The most frequently experienced adverse effects were mild and non-serious in nature.
Currently under evaluation in asthma, COPD, and chronic rhinosinusitis at Sanofi is lunsekimig, a dual-targeting nanobody against IL13 and TSLP. A phase II/III study in COPD is set for 2025, with more readouts scheduled in 2026.
Itepekimab, which has been co-developed with Regeneron, is still active in three phase 3 trials in COPD and is now set to enter further phase 2/3 studies for both CRSwNP and bronchiectasis, with data promises through 2026.
“We are pleased by the significant progress we have made with our pipeline across respiratory indications. In asthma, amlitelimab shows potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation”.
Dr. Houman Ashrafian, Sanofi’s Head for R&D, said.
“If the preliminary effect we have seen is confirmed in phase 3 studies, amlitelimab could become a differentiated treatment option in asthma. These data validate our strategy to advance innovative science and provide new solutions for patients with challenging-to-treat respiratory diseases,”
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