GSK Reports Positive Late-Stage Results for Nucala in COPD

GSK has reported promising outcomes from a late-stage trial of its severe asthma medication, Nucala (mepolizumab), in treating chronic obstructive pulmonary disease (COPD). The phase 3 MATINEE study included adults diagnosed with chronic bronchitis, emphysema, or both, who were already on optimized inhaled maintenance therapy.

Participants in the MATINEE trial also needed to show evidence of type 2 inflammation, identified by elevated blood eosinophil counts. They were randomly assigned to receive either Nucala or a placebo for a period ranging from one to two years. The primary goal of the trial was achieved, as Nucala combined with inhaled maintenance therapy significantly reduced the annualized rate of moderate or severe exacerbations compared to the placebo. The initial safety results were aligned with the known safety profile of Nucala, although further data analysis is still in progress.

COPD is a chronic respiratory condition affecting more than 300 million people globally, leading to a progressive decline in lung function. Around 40% of COPD patients experience type 2 inflammation, which contributes to exacerbations. Nucala aims to inhibit interleukin-5, a crucial protein in type 2 inflammation. Initially approved in 2015 for treating severe asthma in patients with an eosinophilic phenotype, Nucala has since been approved for other conditions such as chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. However, it is not yet approved for COPD.

GSK plans to present the complete results of the MATINEE study at a forthcoming scientific conference, which will also guide ongoing discussions with regulatory authorities.

This announcement follows GSK's recent disclosure of positive results from two advanced-stage studies of another biologic, depemokimab, in severe asthma patients. The SWIFT-1 and SWIFT-2 trials both achieved their main goals, demonstrating a reduction in the annualized rate of clinically significant exacerbations over one year for patients treated with depemokimab compared to a placebo. Another study is currently examining depemokimab in severe asthma patients transitioning from Nucala or AstraZeneca’s Fasenra (benralizumab).

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