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Positive phase 3 data released on investigational mepolizumab

Pivotal phase 3 study data on an investigational interleukin-5 antagonist monoclonal antibody indicates the agent met its primary endpoint in reducing the frequency of exacerbations in patients with severe eosinophilic asthma, according to a company press release.

The efficacy of mepolizumab (GlaxoSmithKline) was examined in two phase 3 studies, according to the release.

The first study, MEA115588, evaluated the efficacy of two dose regimens of mepolizumab for patients with severe eosinophilic asthma. Patients remained on their current asthma maintenance therapy throughout the study and were randomly assigned 75 mg intravenous mepolizumab, 100 mg subcutaneous mepolizumab, or placebo every 4 weeks.

Both treatment arms demonstrated reductions in the frequency of clinically significant exacerbations of asthma compared with placebo (75 mg, 47%; 100 mg, 53%, P<.001 for both).

In the second study, MEA115575, researchers investigated the use of 100 mg subcutaneous mepolizumab every 4 weeks compared with placebo in reducing daily oral corticosteroid use while maintaining asthma control. Data indicated that patients assigned mepolizumab reduced their need for oral corticosteroid doses during weeks 20 to 24, compared with patients on placebo (P=.008), while controlling their asthma.

The most common adverse events were nasopharyngitis, headache, upper respiratory tract infection and asthma.

Full study data will be presented at a future scientific meeting, the release said.