GSK plc (LON: GSK, NYSE: GSK), a leading UK-based pharmaceutical company, has announced positive results from a Phase III trial for its auto-immune therapy Nucala (mepolizumab) in treating chronic obstructive pulmonary disorder (COPD). The MATINEE trial demonstrated that GSK’s interleukin-5 (IL-5) inhibitor met the primary endpoint, showing a significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations compared to placebo, with trial data extending up to two years.
The study targeted COPD patients with chronic bronchitis and/or emphysema who were undergoing optimized inhaled maintenance therapy. Participants were selected based on evidence of type 2 inflammation, indicated by elevated blood eosinophil counts. The addition of Nucala to inhaled maintenance therapy resulted in a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations over a treatment period of up to 104 weeks. The full results from the MATINEE trial are set to be presented at an upcoming scientific congress.
Nucala, initially approved in the US in 2015 for severe asthma with an eosinophilic phenotype, has since expanded its respiratory therapy indications to include Churg-Strauss syndrome, severe eosinophilic asthma, and chronic rhinosinusitis with nasal polyps. The drug generated USD 2.2 billion in revenue in 2023. GSK plans to use the latest data to engage in approval discussions with regulatory authorities. Competing drugs in the market include AstraZeneca’s IL-5-targeted Fasenra (benralizumab) and Sanofi’s IL-4/IL-13 targeted Dupixent (dupilumab).- Flcube.com
