By VETTAPHARMA reporter – Derek Roche: Sanofi announced that its investigational therapy lunsekimig met primary and key secondary endpoints in multiple Phase 2 studies across respiratory diseases, including asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
The AIRCULES Phase 2b study (NCT06102005) achieved its primary and key secondary endpoints in moderate-to-severe asthma, demonstrating statistically significant and clinically meaningful reductions in exacerbations along with improvements in lung function, measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV₁).
In parallel, the DUET Phase 2a study (NCT06454240) in CRSwNP met its primary endpoint of change in nasal polyp score from baseline, as well as key secondary endpoints including improvements in nasal congestion/obstruction score and Lund-Mackay CT (LMK-CT) score at Week 24, all compared to placebo.
However, the VELVET Phase 2b study in moderate-to-severe atopic dermatitis did not meet its primary endpoint, highlighting variability in response across indications.
Lunsekimig is a novel bispecific Nanobody® VHH, composed of five linked antibody fragments, designed to simultaneously target TSLP and IL-13, two key drivers of inflammation associated with asthma and related diseases.
Across all studies, lunsekimig demonstrated an acceptable safety profile and was well tolerated, reinforcing its potential as a next-generation therapy targeting multiple inflammatory pathways.
A senior R&D executive at Sanofi noted that the results support the dual-targeting mechanism of lunsekimig and its potential to address multiple aspects of respiratory disease management through a single therapeutic approach.
