Paris, France, April 7, 2026
Phase 2 Success Across Respiratory Indications
In a major advancement for respiratory disease therapeutics, Sanofi has announced that its investigational biologic lunsekimig successfully met primary and key secondary endpoints in multiple Phase 2 clinical trials, including moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The AIRCULES Phase 2b study demonstrated a statistically significant reduction in asthma exacerbations alongside meaningful improvements in lung function (FEV1), regardless of biomarker status, highlighting its broad therapeutic potential.
Similarly, the DUET Phase 2a study met its primary endpoint by significantly improving nasal polyp scores, along with key secondary endpoints such as nasal congestion and CT imaging outcomes, reinforcing its role in treating chronic inflammatory respiratory conditions. These results position lunsekimig as a promising next-generation biologic targeting multiple pathways in respiratory diseases.
Novel Dual-Target Mechanism Drives Clinical Efficacy
Lunsekimig is a first-in-class bispecific Nanobody® VHH, engineered to simultaneously inhibit TSLP (thymic stromal lymphopoietin) and IL-13, two critical drivers of type 2 inflammation implicated in asthma and related disorders. This dual-targeting mechanism offers a synergistic approach to reducing airway inflammation and tissue damage, addressing limitations of single-target therapies. Clinical data confirm that this mechanism translates into clinically meaningful outcomes, including reduced exacerbation rates and improved respiratory function.
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Importantly, the therapy demonstrated a favorable safety and tolerability profile across all studies, with no significant increase in serious adverse events compared to placebo. Common treatment-emergent adverse events included nasopharyngitis, upper respiratory infections, and injection site reactions, all consistent with expectations for biologic therapies. These findings validate lunsekimig’s potential as a disease-modifying therapy in chronic inflammatory diseases.
Mixed Results in Atopic Dermatitis but Positive Signals
While lunsekimig showed strong efficacy in respiratory indications, results from the VELVET Phase 2b study in moderate-to-severe atopic dermatitis were mixed. The study did not meet its primary endpoint (EASI score reduction); however, key secondary endpoints showed improvement, including higher rates of EASI-75 response and skin clearance (vIGA-AD 0/1).
These findings suggest that while the therapy may have limited efficacy as a primary treatment for atopic dermatitis, it still demonstrates biological activity and clinical potential in certain patient subgroups. The differentiated outcomes across indications highlight the importance of precision targeting and disease-specific mechanisms in immunology drug development, and may guide future clinical strategy and indication prioritization.
Advancing Toward Late-Stage Development
Building on these encouraging Phase 2 results, Sanofi is advancing lunsekimig into late-stage clinical development, including ongoing Phase 3 trials such as PERSEPHONE and THESEUS, as well as additional studies in high-risk asthma populations. With asthma affecting over 262 million people globally, and more than 50% of patients inadequately controlled on current therapies, the need for innovative, multi-target biologics remains significant.
Lunsekimig’s ability to address multiple inflammatory pathways simultaneously positions it as a potential best-in-class therapy in the competitive respiratory biologics market. As Sanofi continues to expand its immunology and inflammation pipeline, lunsekimig represents a critical asset with the potential to transform treatment paradigms and improve outcomes for patients with chronic respiratory diseases.
Source: Sanofi press release
