Friday, GSK plc (NYSE:GSK) released the headline results of the MATINEE Phase 3 trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD), or smoker's lungs.
The trial recruited COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema who were receiving optimized inhaled maintenance therapy.
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Participants were also required to have evidence of type 2 inflammation characterized 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 annualized 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 characterized by raised blood eosinophil count, which drives exacerbations.
The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities.
Nucala is already approved as an add-on, prescription maintenance treatment for patients six and older with severe eosinophilic asthma.
Nucala is currently not indicated for COPD anywhere in the world.
The drug contributed 6% to GSK's 2023 sales, with revenue of 1.65 billion pounds, up 18% at CER year over year.
In June, the FDA approved Verona Pharma plc's (NASDAQ:VRNA) Ohtuvayre (ensifentrine) for the maintenance treatment of COPD in adult patients.
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
Price Action: GSK stock is up 0.86% at $43.50 during the premarket session at last check Friday.
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