GSK Announces Positive Phase III Trial Results for Nucala in COPD Patients
GSK has announced promising headline results from its Phase III clinical trial, MATINEE, which evaluated the efficacy of Nucala (mepolizumab) in adults with chronic obstructive pulmonary disease (COPD). The trial successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations compared to placebo in patients treated for up to two years.
Expanding Nucala’s Impact
GSK’s respiratory blockbuster, Nucala, has now scored a significant win in the COPD arena, further expanding its therapeutic reach. As sales of Nucala continue to climb, this success adds yet another achievement to its portfolio. The drug, a cornerstone of GSK’s respiratory franchise, generated £1.65 billion ($2.2 billion) in revenue throughout 2023. In the second quarter of 2024 alone, Nucala brought in £482 million ($635.7 million), marking a 17% growth at constant exchange rates compared to the same period last year.
The MATINEE study involved COPD patients with varying clinical presentations of chronic bronchitis and/or emphysema, all of whom were receiving optimized inhaled maintenance therapy. Participants also had to exhibit evidence of type 2 inflammation, characterized by elevated blood eosinophil counts. The addition of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), to their existing treatment regimen resulted in a substantial decrease in exacerbation rates, underscoring its potential in managing COPD.
Preliminary safety data from the study aligns with Nucala’s established safety profile, with further detailed analysis ongoing. The full results of the MATINEE trial are expected to be presented at an upcoming scientific congress, which will also inform discussions with regulatory authorities about potential future approvals. Currently, Nucala is not indicated for COPD treatment in any country.
COPD is a significant global health issue, affecting over 300 million people, with up to 40% of patients showing signs of type 2 inflammation driven by elevated eosinophil counts. This form of inflammation is closely linked to exacerbations, which can lead to lung damage, decline in lung function, and increased risk of hospitalization. IL-5, the protein targeted by mepolizumab, plays a crucial role in the type 2 inflammatory pathway, making it a critical target for new therapeutic strategies.
About the Mepolizumab Development Program
MATINEE is part of a broader mepolizumab development program for COPD, which includes two earlier studies, METREX and METREO, completed in 2017. The MATINEE trial builds on the insights gained from these studies and aims to better identify COPD patients who could benefit from Nucala, supporting future regulatory submissions.
Originally approved in 2015 for severe asthma with an eosinophilic phenotype, Nucala targets interleukin-5 (IL-5), a key cytokine in type 2 inflammation, and has been developed for treating a range of IL-5 mediated diseases.
With the success of MATINEE, GSK continues to strengthen its leadership in respiratory medicine, advancing the development of innovative treatments for patients with asthma, COPD, and other respiratory diseases. The company’s ongoing commitment to harnessing cutting-edge science and technology aims to transform the future of respiratory care and improve patient outcomes globally.
For more detailed product and safety information, please consult the summary of product characteristics available for EU and UK markets here.
About GSK
GSK is a global leader in respiratory health, with a broad portfolio of vaccines, targeted biologics, and inhaled medicines aimed at addressing various respiratory conditions. The company is dedicated to pioneering new treatments that go beyond symptom management, focusing on modifying the underlying disease mechanisms to prevent disease progression and improve the quality of life for patients worldwide.
Find out more at gsk.com.
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