Sanofi’s Lunsekimig Cuts Asthma Exacerbations, Improves CRSwNP Scores, Misses Eczema Goal
Phase IIb asthma trial showed reduced exacerbations and improved FEV1, and Phase IIa CRSwNP study delivered nasal polyp and congestion gains, but Phase IIb VELVET atopic dermatitis study failed its EASI endpoint. The TSLP/IL-13 bispecific Nanobody was tolerated and is entering Phase II high-risk asthma and Phase III COPD studies.
1. Respiratory Trials Exceeded Primary Endpoints
Lunsekimig met its primary and key secondary endpoints in the Phase IIb AIRCULES asthma trial by significantly reducing exacerbations and boosting pre-bronchodilator FEV1, and in the Phase IIa DUET CRSwNP study by improving nasal polyp and congestion scores relative to placebo over 24 weeks.
2. Atopic Dermatitis Study Missed Primary Endpoint
In the Phase IIb VELVET trial, lunsekimig did not achieve the targeted change in EASI score for moderate-to-severe atopic dermatitis, although it recorded improvements in skin clearance measures such as EASI-75 and vIGA-AD 0/1 as secondary endpoints.
3. Ongoing Development and Mechanism
The bispecific Nanobody, designed to simultaneously block TSLP and IL-13, was generally tolerated and is advancing into the Phase II AIRLYMPUS study in high-risk asthma as well as the Phase III PERSEPHONE and THESEUS trials in COPD, supporting its potential as a Dupixent successor.