September 6, 2024: UK pharmaceutical giant GSK (GSK.L) announced that its asthma medicine, Nucala (mepolizumab), has shown positive results in a late-stage clinical trial for patients suffering from chronic obstructive pulmonary disease (COPD).
Nucala’s efficacy in COPD treatment
The Phase III MATINEE trial demonstrated that patients treated with Nucala, in conjunction with an inhaled maintenance therapy, experienced a statistically significant reduction in the annualized rate of moderate or severe exacerbations compared to those receiving a placebo.
The trial involved 806 COPD patients who were monitored for up to 104 weeks. The results showed that Nucala was effective in reducing COPD, a condition that affects over 300 million individuals globally and is often referred to as “smoker’s lungs” due to its prevalence among cigarette smokers.
Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a cytokine involved in the regulation of eosinophils—white blood cells that can cause inflammation in the lungs when present in excessive amounts. The study found that up to 40% of COPD patients exhibit type 2 inflammation, characterized by elevated eosinophil counts, which can lead to frequent exacerbations and worsening lung function.
New treatment options
COPD is a progressive disease that leads to chronic inflammation, resulting in persistent respiratory symptoms such as breathlessness and chronic cough. COPD can lead to severe health complications, including hospitalization and increased mortality rates. Current treatment options are limited.
Steve Yancey, Vice President and Medicine Development Lead for mepolizumab at GSK, emphasized the importance of these findings, stating, “The reduction in moderate and severe exacerbations observed is clinically relevant given the need for a new treatment approach in these difficult-to-treat patients.”
Future prospects
Nucala was initially approved in 2015 for severe asthma and has since seen robust sales growth, contributing nearly 6% to GSK’s total revenue in 2023, with sales reaching £1.7 billion. The positive results from the MATINEE trial could lead to regulatory submissions for Nucala’s use in COPD, expanding its market potential and providing new hope for patients suffering from this debilitating condition.
GSK plans to present the full results of the MATINEE trial at an upcoming scientific congress. The company hopes that its Phase III MATINEE trial of Nucala will hasten FDA approval. The company filed for approval of Nucala in 2018, but it was denied, with the agency saying it needed more evidence of efficacy.
In a similar development, Sanofi’s asthma drug after a phase III trial showed “significant improvements in lung function, quality of life” and uncontrolled chronic obstructive pulmonary disease respiratory symptoms.
It is the first drug to demonstrate a “clinically meaningful” reduction, of 30%, in exacerbations compared to the placebo and improve lung function, according to a company statement.
