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GSK plc announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD).
The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema, who were receiving optimised inhaled maintenance therapy. Participants were also required to have evidence of type 2 inflammation characterised by raised blood eosinophil count. MATINEE met its primary endpoint with the addition of Nucala to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.
The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing.
COPD affects more than 300 million people globally with up to 40% of patients exhibiting type 2 inflammation characterised by raised blood eosinophil count, that drives exacerbations. IL-5 is a key messenger protein (cytokine) in type 2 inflammation. Recurrent exacerbations lead to damage to the lungs, progressive lung function decline and risk of hospitalisation. This can result in a vicious cycle of deterioration in overall physical health, which leads to worsening of symptoms and quality of life, and increased mortality.
The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities. Nucala is currently not indicated for COPD anywhere in the world.
About the mepolizumab development programme for COPD
The mepolizumab program in COPD is comprised of three clinical trials. The first two studies, METREX and METREO, completed in 2017. MATINEE was designed to supplement METREX and METREO, building on our learnings from these studies and IL-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication. MATINEE is a multi-centre, randomised, placebo controlled, double-blind, parallel group study. The trial is designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in 806 COPD participants who were randomised to receive mepolizumab, or a placebo, as an add on to their optimised maintenance COPD therapy for at least 52 weeks and up to a maximum of 104 weeks.
