Sanofi: Lunsekimig Drug Candidate Passes Two Key Trials
Sanofi announces that its drug candidate lunsekimig has met its primary and key secondary endpoints in two Phase 2 studies for moderate to severe asthma and chronic rhinosinusitis with nasal polyps. The company notes that the compound was well tolerated across the trials.
Significant Results in AIRCULES and DUET Studies
In the Phase 2b AIRCULES study, lunsekimig demonstrated a statistically significant and clinically relevant reduction in asthma exacerbations and an improvement in lung function in adult patients with moderate to severe asthma despite standard treatment. Concurrently, the Phase 2a DUET study showed that lunsekimig met its primary endpoint regarding the change in nasal polyp score, as well as its key secondary endpoints measuring patient-reported nasal congestion and obstruction and changes in computed tomography scores, all compared to placebo at week 24.
Lunsekimig's Mechanism and Ongoing Studies
Lunsekimig is a pentavalent VHH Nanobody® designed to simultaneously block thymic stromal lymphopoietin and interleukin-13, two distinct inflammatory factors contributing to tissue damage in asthma and related diseases. A separate exploratory Phase 2b study named VELVET, focusing on moderate to severe atopic dermatitis, did not meet its primary endpoint; however, improvements were observed in key secondary endpoints. Lunsekimig continues its clinical development in the Phase 2 AIRLYMPUS study on high-risk asthma, as well as in the Phase 3 PERSEPHONE and THESEUS studies. Its safety and efficacy have not been evaluated by any regulatory authority.