GlaxoSmithKline has reported positive late-stage data showing the benefit of its biologic Nucala (mepolizumab) in patients with nasal polyps in patient requiring further surgeries for the condition.
The pivotal SYNAPSE study met both co-primary endpoints, with the drug, when added to standard of care, demonstrating statistically significant improvements in both the size of nasal polyps and in nasal obstruction compared to placebo added to standard of care.
According to the data, the difference in median change from baseline for the total endoscopic nasal polyps score was -0.73, while the difference in median change from baseline for nasal obstruction visual analogue scale score was -3.14.
The results show that Nucala “represents a promising alternative for patients who are caught in a cycle of surgeriesm,” noted Claus Bachert, Professor and chief of Clinics ENT Department at Ghent University, “Each surgery carries risks and can disable the patient for several weeks,” he added.
GSK says this is the first time an anti-IL5 biologic has reported positive Phase III data for nasal polyps, adding to the range of eosinophil-driven diseases in which Nucala has efficacy data.