Phase 3 Study Results for Severe Eosinophilic Asthma Drug
GlaxoSmithKline announced results from a Phase 3 study of mepolizumab, an investigational IL-5 antagonist monoclonal antibody for the reduction in the frequency of exacerbations in patients with severe eosinophilic asthma.
The MEA115588 study was a 32-week double-blind, double dummy, placebo-controlled, parallel group, multicenter trial that evaluated the efficacy of two dose regimens of mepolizumab in patients with severe asthma (n=576), who had experienced frequent exacerbations despite treatment with high dose inhaled corticosteroids (ICS) plus at least one other controller medication. Patients remained on their current asthma maintenance therapy throughout the study and were randomized to receive either mepolizumab 75mg IV, 100mg SC, or placebo every four weeks.
The primary endpoint for this study was met with both mepolizumab treatment arms demonstrating statistically significant reductions in the frequency of clinically significant exacerbations of asthma compared to placebo (75mg IV, 47%, P<0.001; 100mg SC, 53%, P<0.001).
In addition, a second Phase 3 study (MEA115575) designed to evaluate the use of mepolizumab 100mg SC, every 4 weeks in comparison to placebo in reducing daily oral corticosteroid use while maintaining asthma control also met its primary endpoint. The study showed that patients on mepolizumab 100mg SC were able to achieve greater reductions in their maintenance oral corticosteroid dose during Weeks 20–24 compared to patients on placebo (P=0.008), while maintaining asthma control.
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