GSK Reports Positive Phase III Results for Nucala in COPD

LONDON, UK I September 06, 2024 I GSK plc (LSE/NYSE: GSK) has announced encouraging results from its MATINEE phase III clinical trial, which evaluated Nucala (mepolizumab) in adults with chronic obstructive pulmonary disease (COPD). Mepolizumab is a monoclonal antibody that targets interleukin-5 (IL-5), a key protein involved in type 2 inflammation. The study focused on COPD patients suffering from chronic bronchitis and/or emphysema, all of whom were receiving optimized inhaled maintenance therapy and exhibited elevated blood eosinophil counts indicative of type 2 inflammation.

The MATINEE trial achieved its primary endpoint, demonstrating that adding Nucala to standard maintenance therapy significantly reduced the annual rate of moderate to severe exacerbations over a period of up to 104 weeks compared to a placebo group. These findings hold both statistical and clinical significance. Initial safety analysis suggests that the safety profile of Nucala remains consistent with what is already known about the drug. Further data evaluation is ongoing.

Chronic obstructive pulmonary disease affects over 300 million people globally. Roughly 40% of these patients show signs of type 2 inflammation, which leads to frequent and severe exacerbations. Interleukin-5 plays a central role in this type of inflammation. Recurrent episodes of exacerbation can cause substantial lung damage, a decline in lung function, increased hospitalizations, and ultimately higher mortality rates, creating a detrimental cycle of deteriorating physical health and quality of life.

The full data from the MATINEE trial will be shared at an upcoming scientific conference and will contribute to ongoing regulatory discussions. As of now, Nucala is not approved for the treatment of COPD in any part of the world.

The mepolizumab development program for COPD includes three clinical trials: METREX, METREO, and MATINEE. The first two trials, METREX and METREO, were completed in 2017. MATINEE was designed to build on the insights from these earlier studies and further investigate the benefits of mepolizumab in identifying COPD patients who could benefit the most from this treatment. The aim is to support future regulatory submissions and potential approvals.

MATINEE is a multi-center, randomized, placebo-controlled, double-blind, parallel-group study. It sought to confirm the benefits of mepolizumab in reducing moderate or severe exacerbations in 806 COPD patients. These participants were randomized to receive either mepolizumab or a placebo, in addition to their optimized maintenance therapy, for a minimum of 52 weeks and up to 104 weeks.

Nucala, initially approved in 2015 for treating severe asthma with an eosinophilic phenotype in the US, targets and binds to IL-5. It has been developed for treating various IL-5 mediated diseases associated with type 2 inflammation.

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally, with exacerbations contributing significantly to the healthcare burden. Patients with COPD often endure chronic inflammation, leading to persistent respiratory symptoms such as breathlessness and a productive cough, which can severely impact daily life and mental health. Exacerbations result in acute worsening of symptoms, hospitalization, irreversible lung damage, or even death. Despite standard treatments, many patients continue to experience exacerbations, underscoring the need for targeted therapies addressing the underlying biology of the disease.

IL-5 is crucial in type 2 inflammation, influencing the growth, maturation, activation, and survival of eosinophils, which are key in the pathogenesis of type 2 inflammatory diseases. It also impacts other cell types involved in inflammation, lung remodeling, and disease progression.

GSK is committed to advancing respiratory medicine through innovative treatments aimed at improving outcomes and quality of life for patients with respiratory diseases worldwide. The company's robust respiratory portfolio and pipeline include vaccines, targeted biologics, and inhaled medicines, focusing on addressing disease dysfunction and progression.

GSK is a global biopharmaceutical leader dedicated to uniting science, technology, and talent to combat diseases effectively.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!