12th Mar 2014 17:41
LONDON (Alliance News) - GlaxoSmithKline PLC Wednesday said a pivotal phase III study of mepolizumab, an investigational IL-5 antagonist monoclonal antibody, has met its primary endpoint of reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma.
The study evaluated the efficacy of two dose regimens of mepolizumab in the treatment of patients with severe eosinophilic asthma.
The firm said patients remained on their current asthma maintenance therapy throughout the study and were randomised to receive either mepolizumab 75mg intravenous,100mg subcutaneous, or placebo every four weeks.
"For the primary end point, both mepolizumab treatment arms showed statistically significant reductions in the frequency of clinically significant exacerbations of asthma compared to placebo," it added.
The most common reported adverse events across all treatment groups were nasopharyngitis, headache, upper respiratory tract infection and asthma.
In addition, a second phase III study 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 , while maintaining asthma control.
The most common reported adverse events in the two treatment groups were headache nasopharyngitis, bronchitis, sinusitis, fatigue and asthma, the company said.
The stock closed at 1,662.66 pence Wednesday, down 11.34 pence or 0.7%.
By Anthony Tshibangu; [email protected]; @AnthonyAllNews
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