GSK’s Asthma drug meets primary goal in Phase III Trial

UK—British drugmaker GSK has announced that its asthma drug, Nucala (mepolizumab), has achieved the primary goal in a Phase III clinical trial for treating patients with chronic obstructive pulmonary disease (COPD), commonly referred to as “smoker’s lungs.”

Nucala, a monoclonal antibody that targets interleukin-5 (IL-5), plays a pivotal role in controlling type 2 inflammation, which is often characterised by elevated blood eosinophil levels.

This type of inflammation affects approximately 40% of COPD patients and is a major driver of disease exacerbations.

Unchecked, recurrent exacerbations can lead to permanent lung damage, a decline in lung function, and an increased risk of hospitalization.

Ultimately, this contributes to a cycle of deteriorating physical health, worsening symptoms, lower quality of life, and higher mortality rates.

This update follows the results of the MATINEE Phase III trial, which revealed that when Nucala was added to inhaled maintenance therapy, it significantly reduced the annualised rate of moderate or severe exacerbations in patients compared to a placebo.

Although GSK did not release detailed data, it highlighted a “statistically significant and clinically meaningful reduction” in exacerbations between the two groups over the two-year trial period.

The company further noted that ongoing analysis is conducted, while initial safety results align with Nucala’s established safety profile.

The Phase III trial (NCT04133909) enrolled 806 patients aged 40 and older who had COPD, a group of lung conditions that impair breathing and primarily affect middle-aged and older adults, particularly those with a history of smoking.

According to the ClinicalTrials.gov database, the multi-centre, randomised, placebo-controlled, double-blind trial was conducted across various regions, including the Americas, Europe, and Asia.

In the study, Nucala was administered via subcutaneous injection every four weeks as an add-on therapy.

COPD remains a global health challenge, affecting over 300 million people worldwide.

Although Nucala was initially approved in 2015 for the treatment of severe asthma with an eosinophilic phenotype in the United States, it is not currently indicated for COPD in any country.

However, the full results from the MATINEE trial are expected to be presented at an upcoming scientific conference and will contribute to discussions with regulatory bodies.

Regarding market performance, Nucala generated £1.6 billion (US$2.1 billion) in revenue for GSK in 2023, marking an 18% increase from the previous year.

GlobalData’s Pharma Intelligence Center Analysts predict the drug’s peak sales will reach US$2.35 billion by 2026.

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