GSK announces positive results for Nucala in COPD treatment

Image of a male and female doctor consulting over an x-ray of lungs.

A phase III clinical trial has found that Nucala (mepolizumab) has met the primary endpoint with a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations compared to a placebo in patients with COPD.

GSK, the manufacturer of Nucala, said in a news release that the MATINEE trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema who were receiving optimized, inhaled maintenance therapy. They were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count.

MATINEE was a multi-center, randomized, placebo-controlled, double-blind, parallel group study that included 806 patients with COPD.

The trial met its primary endpoint with the addition of Nucala inhaled maintenance therapy. The company said the results showed “a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations versus placebo with patients treated for up to 104 weeks.”

The development of Nucala as a treatment for COPD is comprised of three clinical trials. The first two, METREX and METREO, were completed in 2017. GSK said the third trial, MATINEE, was designed to supplement the other two, building on learnings from the previous studies and research into IL-5 — a key messenger protein in type 2 inflammation — to identify the patients who could benefit most from the Nucala treatment.

The company will present the full results of the MATINEE study at a later congress and will continue discussions with regulatory authorities. Nucala is currently not approved for treating COPD anywhere in the world.

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