GSK announces positive results from phase III trial of Nucala in COPD
London: GSK plc has 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.
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First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.
