GSK's Nucala delivers positive outcomes in published trial results

(Sharecast News) - GSK announced on Thursday that its monoclonal antibody 'Nucala', or mepolizumab, delivered a statistically significant and clinically meaningful reduction in exacerbations for patients with chronic obstructive pulmonary disease (COPD), according to final results from the phase three MATINEE trial published in the New England Journal of Medicine. The FTSE 100 pharmaceuticals giant said the data supported ongoing regulatory submissions, with a decision from the US FDA expected by 7 May.

It said the trial met its primary endpoint, showing a 21% reduction in the annualised rate of moderate-to-severe COPD exacerbations versus placebo in a broad patient population with type two inflammation.

In a post-hoc analysis of patients with chronic bronchitis only, mepolizumab delivered a 31% reduction.

The study also demonstrated a 35% decrease in the annualised rate of exacerbations that led to emergency department visits or hospitalisations, a key secondary endpoint.

GSK said the MATINEE study included patients across the COPD spectrum, including those with chronic bronchitis, emphysema or both, and was conducted over a period of up to 104 weeks.

Mepolizumab was administered monthly, with benefits observed consistently across multiple exacerbation-related outcomes.

While high response rates were reported in patient-reported outcomes, there was no significant difference compared to placebo on the St George's Respiratory Questionnaire, COPD Assessment Test, or the Evaluating Respiratory Symptoms tool.

The safety profile of mepolizumab was comparable to placebo, with adverse events occurring in 74% of the treatment group versus 77% in placebo, and similar incidence of Covid-19 infection and disease worsening in both arms.

Nucala is not currently approved for COPD treatment in any jurisdiction, but regulatory reviews were underway in the US, China and the European Union.

Hospitalisation due to COPD remained a major clinical and economic burden globally, and GSK noted that mepolizumab is the only biologic to show hospitalisation reduction in a phase three COPD trial to date.

"Today's MATINEE results show that mepolizumab can help prevent exacerbations, including those leading to emergency department visits and/or hospitalisation," said Kaivan Khavandi, GSK's senior vice-president and global head of respiratory, immunology and inflammation research and development.

"These exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms and increased mortality.

"For decades, we have and will continue to push the boundaries of innovation to prevent disease progression and make a meaningful impact on the lives of people affected by COPD."

At 1049 BST, shares in GSK were down 1.21% at 1,465.5p.

Reporting by Josh White for Sharecast.com.