GSK PLC (LSE:GSK, NYSE:GSK) announced positive results from a Phase III clinical trial, MATINEE, evaluating Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD).
The trial met its primary endpoint by demonstrating a statistically significant reduction in the annualized rate of moderate to severe exacerbations in patients treated with Nucala compared to a placebo.
The MATINEE trial recruited patients with chronic bronchitis or emphysema, receiving optimized inhaled maintenance therapy.
Patients also had elevated blood eosinophil counts, a biomarker of type 2 inflammation, which is linked to COPD exacerbations.
Patients in the study were treated for up to 104 weeks, and the preliminary safety results were consistent with the existing safety profile of Nucala.
Full results from the MATINEE trial will be presented at an upcoming scientific congress, and will support discussions with regulatory authorities.
Currently, Nucala is not approved for use in COPD in any country.