GlaxoSmithKline is eyeing another indication for its Nucala (mepolizumab) biologic drug after a phase 3 trial in inflammation caused by nasal polyps hit its targets, bringing it into competition with Sanofi’s big-selling Dupixent.
The development also heats up a class rivalry with Teva and AstraZeneca, whose Il-5 drugs Cinqair (reslizumab) and Fasenra (benralizumab) are not approved in this disease.
This is the first time a biologic in this class has reported positive phase 3 data in chronic rhinosinusitis with nasal polyps (CRSwNP), GSK noted.
SYNAPSE is the first study to test the benefit of biologic treatment for patients, who all had a history of previous surgery and were in need of another op due to severe symptoms and increased size of their polyps.
GSK said the study of more than 400 patients met both co-primary endpoints, with Nucala added to standard of care, demonstrating statistically significant improvements in both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52, compared to placebo added to standard of care.
The drug also significantly reduced the likelihood of nasal surgery over the course of the study, meeting a secondary endpoint.
Claus Bachert, MD, Professor and Chief of Clinics ENT Department at Ghent University said: “The impact of CRSwNP on patients is substantial, but often underestimated.
“Treatment options are currently limited. These results show mepolizumab represents a promising alternative for patients who are caught in a cycle of surgeries. Each surgery carries risks and can disable the patient for several weeks.”
The safety results in the study were consistent with the known profile of mepolizumab, GSK said, adding that it plans regulatory filings this year in the potential new indication.
CRSwNP is a chronic inflammatory disease of the nasal passage linings or sinuses leading to soft tissue growth known as nasal polyps in the upper nasal cavity and is characterised by elevated levels of eosinophils.
A first in class drug approved by the FDA in 2015, Nucala binds to IL-5 receptors on the surface of white blood cells known as eosinophils, which are overstimulated in several inflammatory diseases including CRSwNP.
Since then AZ and Teva have bought rivals to market, but if approved in CRSwNP Nucala will take on Sanofi’s Dupixent (dupilumab) which has a different mechanism of action and was FDA-approved in CRSwNP last year.