GSK plc on Monday announced a positive outcome in the phase III trial to treat chronic obstructive pulmonary disease (COPD). According to the company’s statement, the phase III clinical trial evaluating Nucala (mepolizumab) 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 company said in a statement.
The preliminary safety results are consistent with the known safety profile of Nucala. Further analysis of these data is ongoing, it added.
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, the company informed.
The mepolizumab programme 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.
COPD is the third leading cause of death worldwide with exacerbations accounting for the greatest proportion of the total COPD burden on the healthcare system. Patients with COPD have chronic inflammation leading to persistent respiratory symptoms such as breathlessness and a productive cough. The daily impact on patients’ lives can lead to anxiety and depression.
