Sanofi announced on Apr. 7 that its bispecific antibody lunsekimig showed positive results in mid-stage clinical trials for asthma and chronic rhinosinusitis with nasal polyps, but did not meet the main goal in a separate trial for atopic dermatitis.
The news is significant as Sanofi has positioned lunsekimig as a central part of its future pipeline, projecting potential sales between $2.15 billion and $5.4 billion for the drug. The company is seeking to regain investor confidence by highlighting several possible blockbuster drugs.
In the Phase 2b AIRCULES study, lunsekimig was added to standard care in adults with moderate-to-severe asthma and achieved its primary endpoint by significantly reducing exacerbations and improving lung function. The Phase 2a DUET trial also met its goals, showing improvement in both the size of nasal polyps at week 24 and patient-reported symptoms such as congestion and obstruction.
However, lunsekimig did not succeed in improving the severity of atopic dermatitis—the most common form of eczema—in the Phase 2b VELVET study. While there were improvements on a secondary measure involving disease clearance rates among patients, analysts from Leerink Partners said "We were not surprised by the disappointment of the atopic derm trial as we had low expectations given the limited evidence of synergistic biology in this indication." Efficacy data comparing lunsekimig to competitors have not yet been provided; Sanofi plans to share more details at an upcoming medical meeting.
Sanofi executives previously described running an eczema trial with this drug as a "measured risk," noting that while IL-13's role is established in this condition, TSLP remains experimental. Across all studies so far, serious adverse event rates were similar between those taking lunsekimig and placebo groups.
Looking ahead, Sanofi continues to test lunsekimig in additional trials including AIRLYMPUS for high-risk asthma and late-stage studies PERSEPHONE and THESEUS targeting chronic obstructive pulmonary disease.
