GSK reports positive Phase III results of mepolizumab for COPD
GlaxoSmithKline (GSK) has reported positive results from two Phase III clinical trials of mepolizumab to treat patients with eosinophilic chronic obstructive pulmonary disease (COPD).
Mepolizumab is a monoclonal antibody being developed to target the signalling protein IL-5 and prevent its binding to a receptor on the surface of eosinophils.
The results indicated that use of 100mg of mepolizumab in combination with maximal guideline-recommended therapy has decreased COPD exacerbations by 18%-20%.
In the METREX and METREO trials, mepolizumab’s safety and efficacy as an add-on therapy were assessed in patients at high risk of exacerbations.
METREO additionally evaluated efficacy and safety of a 300mg dose of mepolizumab.
The multi-centre, randomised, placebo controlled, double blind, parallel group trials also aimed to identify patients who were most likely to respond to treatment with eosinophils as a biomarker.
A pre-specified meta-analysis indicated that the decrease in exacerbation rates increased with a rise in blood eosinophil counts, allowing identification of subjects most likely to respond to mepolizumab.
The Phase III trials involved subcutaneous (SC) mepolizumab injection every four weeks over a period of around 62 weeks, including a 52-week treatment period and eight week follow-up period.
GSK mepolizumab vice-president and medicine development lead Steve Yancey said: “We believe the data published today in the New England Journal of Medicine demonstrate the benefits of a personalised medicine approach in the treatment of COPD with mepolizumab, using blood eosinophils as a biomarker.
“Based on the clinically meaningful reductions in exacerbations shown in these studies, we plan to progress regulatory filings this year.”
GSK also reported positive results from the Phase III Salford Lung Study conducted over a duration of 12 months in 4,233 subjects with asthma.
The results showed that once-daily 92mcg / 22mcg or 184mcg / 22mcg of Relvar Ellipta was superior to standard-of-care in achieving improvement in asthma control.
Image: Chest X-ray of a COPD patient with lung bulla. Photo: courtesy of James Heilman via Wikimedia Commons.