AIRCULES: Lunsekimig Benefit Scales With Severity, With Njira Lugogo, MD

New subgroup data from the phase 2b AIRCULES trial show that lunsekimig, Sanofi's bispecific Nanobody targeting both thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), produced larger exacerbation reductions in patients with more severe or biomarker-high asthma, according to Njira Lugogo, MD, MS, clinical professor of medicine and director of the Michigan Medicine Asthma Program at the University of Michigan. Lugogo discussed the data, presented at the European Respiratory Society (ERS) Congress 2026 in Barcelona, Spain, held September 5 to 9, in an interview with HCPLive.

“I'm really excited about lunsekimig specifically because this is the first bispecific biologic that we have in asthma,” she said, noting that most existing biologics target a single pathway despite evidence of redundant, overlapping inflammatory mechanisms in severe disease.

AIRCULES previously met its primary and key secondary endpoints compared with placebo, with lunsekimig added to standard of care in adults with moderate-to-severe asthma across the full range of fractional exhaled nitric oxide (FeNO) and eosinophil values.1 Lugogo said the annualized exacerbation reduction was about 39% in the overall population, rising to 55% at the highest dose tested (300 mg every 4 weeks). The effect was more pronounced in prespecified subgroups: patients with a history of more than 3 exacerbations had nearly an 80% reduction, those with high baseline FeNO had a significant exacerbation reduction alongside a lung function improvement and met the minimal clinically important difference on the Asthma Control Questionnaire, and patients with eosinophil counts above 300 cells/µL also showed a more robust response than the overall population, including improved forced expiratory volume in 1 second.

Lugogo said the dual-target mechanism has a specific rationale beyond simply combining 2 pathways: blocking TSLP upstream may help offset the eosinophil increase sometimes seen with IL-13 blockade alone, while both pathways have independently been linked to mucus reduction and lung function improvement. She also pointed to lunsekimig's potential to address comorbid type 2 conditions, such as sinonasal disease and atopic dermatitis, beyond asthma itself, based in part on her own clinical experience using dual-biologic combinations in patients with overlapping disease. On safety, she said the novel Nanobody platform showed a low rate of anti-drug antibodies and treatment-emergent adverse events similar between placebo and treatment arms, with no signals prompting concern heading into phase 3.

Lugogo said the subgroup data are meant to inform which patients should be prioritized in the phase 3 program and to help settle on a single dose going forward. She framed the results within a broader unmet need: only about 35% of patients with severe asthma currently achieve remission, and she said dual-pathway blockade could help expand that proportion. An early-intervention study of lunsekimig in high-risk patients, AIRLYMPUS, is expected to read out results next year.

References

1. Sanofi. Sanofi's lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in asthma and CRSwNP. Published April 7, 2026.

2. ClinicalTrials.gov. A study of lunsekimig (SAR443765) in adult participants with moderate to severe asthma (AIRCULES). Identifier: NCT06102005.