Sanofi Expands Respiratory Pipeline With Encouraging Amlitelimab Results And New COPD Trials

Sanofi has released encouraging early results from its respiratory pipeline, particularly for amlitelimab in moderate-to-severe asthma. In the Phase 2 TIDE-Asthma study, amlitelimab showed clinically meaningful reductions in asthma exacerbations, especially at the medium dose, although the primary endpoint at the highest dose was not met. The treatment improved lung function and asthma control, particularly in biomarker-defined subgroups (eosinophils ≥300 cells/mL and elevated neutrophils), where exacerbations dropped by over 70%. These outcomes suggest amlitelimab may be a breakthrough option for patients with heterogeneous inflammatory asthma, and a Phase 3 trial is being planned.

Houman Ashrafian, an Executive Vice President and Head of Research & Development said, “We are pleased by the significant progress we have made with our pipeline across respiratory indications. Amlitelimab shows potential as an effective, long-acting medicine for asthma, including in patients with moderate-to-severe heterogene inflammation. 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.”

Amlitelimab works through a non-depleting mechanism targeting OX40-Ligand to restore immune balance. Patients received treatment every four weeks for six months and then every twelve weeks, highlighting its potential for quarterly maintenance dosing. Across 60 weeks, the safety profile remained consistent, with no new safety signals. Adverse events were mild to moderate and comparable to placebo, the most common being COVID-19, bronchitis, sinusitis, and headaches. Complete data will be shared at an upcoming medical meeting.

Sanofi also provided updates on other pipeline assets. Lunsekimig, with Phase 2 studies ongoing in asthma and planned expansion into COPD in 2025, is being explored across inflammatory spectrums. Itepekimab, co-developed with Regeneron, is progressing through multiple late-stage studies in COPD and chronic rhinosinusitis with and without nasal polyps, and the results are expected by late 2025 or 2026.