Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.”
Sanofi’s lunsekimig, a bispecific the French pharma has placed at the center of its future pipeline and growth strategy, improved symptoms of asthma and rhinosinusitis in a pair of mid-stage trials. But the therapy was not as successful in a separate trial for atopic dermatitis, the most common form of eczema, failing to improve the severity of the skin disorder.
Lunsekimig is one of the nine assets Sanofi has included in future sales projections that could reach between $2.15 billion and $5.4 billion each.
Analysts from Leerink Partners brushed off the eczema failure, as questions about the drug’s ability to target the condition had already been raised.
“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,” they wrote Tuesday morning.
Sanofi’s expansive clinical program for the asset includes the Phase 2b AIRCULES study that added lunsekimig to standard of care in adults with moderate-to-severe asthma across the range of FeNO (fractional exhaled nitric oxide) and eosinophil values. The Phase 2a DUET trial compared lunsekimig to placebo in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
In AIRCULES, lunsekimig achieved the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in exacerbations of asthma and improving lung function.
DUET, meanwhile, was also successful, with the drug at week 24 meeting the main goal of change in the size of nasal polyps and the secondary goal of a change in patient-reported nasal congestion and obstruction.
Sanofi heralded the results as proof that lunsekimig can address multiple aspects of respiratory disease management, according to a Tuesday statement.
But the drug failed to meet its primary goal of improving the severity of atopic dermatitis in the Phase 2b VELVET study, though there were improvements on a secondary endpoint, the proportion of patients who achieved 75% or more clearance of their disease.
Leerink noted that efficacy data were not provided for any of the trials, so a comparison to competitors could not be made. Sanofi promised to reveal more at an upcoming medical meeting.
Sanofi has faced questions about the potential of lunsekimig, which targets thymic stromal lymphopoietin (TSLP) and IL-13, to have an impact in atopic dermatitis. Executives admitted at the J.P. Morgan Healthcare Conference earlier this year that running the trial was a “measured risk.” While IL-13 has long been established in the condition, TSLP is still experimental, although Sanofi has said that data from other molecules support exploration.
Lunsekimig was generally well tolerated across the studies, with serious adverse event rates similar across the drug group and placebo comparators.
Sanofi is also running the Phase 2 AIRLYMPUS study of lunsekimig in high-risk asthma, as well as late-stage trials, PERSEPHONE and THESEUS, in chronic obstructive pulmonary disease.
