Lunsekimig’s Phase IIb asthma data strengthen its case as a differentiated next-generation biologic, with dose-dependent reductions in exacerbations and improvements in lung function supporting progression into Phase III. The results could sharpen Sanofi’s strategy to defend its respiratory franchise ahead of Dupixent’s patent expiry, while intensifying competition in an increasingly crowded asthma biologics market, says GlobalData, a leading intelligence and productivity platform.

Lunsekimig, a bispecific Nanobody (VHH) that targets both thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), is used as an add-on therapy in adults with moderate to severe asthma.

Sanofi presented detailed efficacy and safety data from the Phase IIb AIRCULES trial at the 2026 European Respiratory Society (ERS) International Congress.

Zaid Mahmood, Healthcare Analyst at GlobalData, comments: “The data presented at ERS 2026 confirmed dose-dependent efficacy alongside a clean safety profile, giving Sanofi a clear basis to advance lunsekimig into Phase III development.”

Lunsekimig met its primary endpoint across all three regimens, with the annualized asthma exacerbation rate (AAER) over 48 weeks falling progressively across the dose range (60mg q4w 300mg q4w, 300mg q8w). However, only the highest 300mg q4w regimen reached statistical significance. Lung function followed the same pattern, with pre-bronchodilator FEV1 improving at week 48 across all arms and most markedly at the highest dose. The drug was generally well tolerated, with severe treatment-emergent adverse events comparable to or lower than placebo.

Mahmood adds: “A 55.3% reduction in exacerbations at the highest dose is a compelling outcome, and the consistent dose-response observed across all three regimens gives Sanofi a well-supported basis for selecting a lead dose for Phase III.”

These results are expected to support Sanofi’s move into a larger Phase III trial, central to defending its immunology franchise ahead of the 2031 loss of exclusivity for Dupixent (dupilumab), which generated over $17 billion globally in 2025 across eight different indications.

Mahmood continues: “Following the discontinuation of itepekimab in COPD after mixed Phase III results, and the earlier discontinuation of amlitelimab in asthma, lunsekimig is now Sanofi’s leading respiratory pipeline asset.”

The asthma biologics market remains highly competitive, with six agents approved across five mechanisms of action. However, lunsekimig’s direct competitors are Dupixent, which dominates in type 2-high asthma, and AstraZeneca/Amgen’s Tezspire (tezepelumab), the only other biomarker-agnostic option, against both of which lunsekimig’s efficacy will likely be judged.

Mahmood concludes: “The key opinion leaders interviewed by GlobalData are especially enthusiastic about the drug’s bispecific approach, especially if used in combination with other targeting biologics. Data from AIRCULES gives Sanofi a solid strategy to defend its position in the asthma market ahead of Dupixent’s patent expiry.”