Sanofi (SNY) announced that its investigational therapy Lunsekimig met both primary and key secondary endpoints in two Phase 2 studies targeting chronic respiratory conditions, underscoring its potential as a novel treatment option.
The AIRCULES Phase 2b study evaluated Lunsekimig in adults with moderate-to-severe asthma. Results showed a statistically significant reduction in asthma exacerbations and meaningful improvements in lung function compared to placebo.
Asthma affects more than 260 million people worldwide, and despite available therapies, over half of patients still struggle with uncontrolled symptoms.
The DUET Phase 2a study tested Lunsekimig in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The therapy achieved its primary endpoint, including improvements in nasal congestion score, nasal polyp score, and Lund-Mackay Computed Tomography (LMK-CT) score at Week 24, all compared to placebo. CRSwNP is a persistent inflammatory condition often associated with asthma, causing congestion, facial pressure, and loss of smell.
Lunsekimig is pentavalent Nanobody VHH designed to simultaneously block two inflammatory drivers-TSLP and IL-13- which contribute to tissue damage in asthma and related diseases. By targeting both pathways, the therapy may offer additive benefits over existing treatments. Across the studies, Lunsekimig was well tolerated, with treatment-emergent adverse events (TEAEs) comparable to placebo.
Sanofi noted that while the exploratory VELVET Phase 2b study in atopic dermatitis did not meet its primary endpoint, improvements were observed in secondary measures such as EASI-75 (skin clearance).
The company plans to present detailed results at upcoming medical congresses. Lunsekimig continues in development with additional Phase 2 and Phase 3 studies, including the PERSEPHONE trial, which is designed to evaluate Lunsekimig in patients with moderate-to-severe asthma, focusing on exacerbation rates and lung function outcomes. The THESEUS trial will assess Lunsekimig in patients with CRSwNP, measuring improvements in nasal polyp size, congestion, and quality of life but it has not yet been evaluated by regulatory authorities.
SNY has traded between $43.32 and $55.73 over the past year. The stock closed Monday's trading at $47.60, down 0.61%. In pre-market trading the stock is at $47.77, up 0.36%.
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