GSK’s asthma drug Nucala (mepolizumab) has met the primary endpoint in a Phase III trial treating patients with chronic obstructive pulmonary disease (COPD).
Data from the MATINEE study showed that when added to inhaled maintenance therapy, patients had a reduced annualised rate of moderate or severe exacerbations when compared to placebo.
GSK did not disclose further data, saying only there was a “statistically significant and clinically meaningful reduction” between the two treatment groups up to two years. The drugmaker added that further analysis of the data is ongoing, with preliminary safety results consistent with Nucala’s known safety profile.
The late-stage trial (NCT04133909) involved 806 patients aged 40 years and older with COPD – the name given to a group of lung conditions that cause breathing difficulties. The disease affects more than 300 million people globally, with middle-aged and older adults who smoke representing the main patient group.
The multi-centre, randomised, placebo-controlled, double-blind, parallel-group study was conducted at sites across the Americas, Europe, Asia, and others, according to theClinicalTrials.gov listing. Nucala was administered as an add-on therapy via subcutaneous injection once every four weeks.
According to its full-year 2023 earnings, GSK said it expects regulatory submission for Nucala’s use in COPD in the EU and Canada in 2025. A GSK spokesperson did not confirm a specific timeframe to Pharmaceutical Technology.
Nucala is an interleukin-5 (IL-5) antagonist monoclonal antibody approved for the treatment of asthma, with additional indications in chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).
The drug, which was first approved in 2015, generated £1.6bn ($2.1bn) in revenue in 2023 for GSK, up 18% from the year before.
It is predicted to see peak sales of $2.35bn in 2026, according to analysis by GlobalData’s Pharma Intelligence Center.
A big hitter recently joined the COPD space, when the European Medicines Agency (EMA) approved Sanofi‘s Dupixent (dupilumab) for the disease in July this year. The drug became the first targeted therapy for adults with uncontrolled COPD, characterised by raised blood eosinophils. Similar to Nucala, Dupixent is also used to treat asthma, of which it holds significant market dominance – full-year sales for the drug in 2023 generated $11.59bn, up 33% from the year before.
