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ARTICLE | Clinical News

GSK's mepolizumab meets in two Phase III asthma trials

March 13, 2014 1:02 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reported data on Wednesday from two Phase III trials evaluating Bosatria mepolizumab ( SB-240563) as adjunctive treatment for severe uncontrolled refractory asthma. In the MEA115588 trial, IV mepolizumab or subcutaneous mepolizumab given every four weeks for 32 weeks each met the primary endpoint of reducing the frequency of clinically significant asthma exacerbations vs. placebo (p<0.001 for both). The double-blind, international trial enrolled 576 patients with severe eosinophilic asthma and frequent exacerbations despite treatment with high-dose inhaled corticosteroids and one or more other controller medication.

In the MEA115575 trial, subcutaneous mepolizumab given every four weeks for up to 20 weeks met the primary endpoint of a greater reduction from baseline in maintenance oral corticosteroid dose during weeks 20-24 while maintaining asthma control vs. placebo (p=0.008). The double-blind, international trial enrolled 135 patients with severe eosinophilic asthma on regular treatment with oral corticosteroids, high-dose inhaled corticosteroids and an additional controller medication. ...