GlaxoSmithKline maps a route to regulators with positive PhIII asthma data

GlaxoSmithKline says it nailed the primary endpoint in a Phase III study of its injectable IL-5 drug mepolizumab, beating out a placebo with statistically significant results for severe eosinophilic asthma and setting the stage for the first regulatory filings for the drug.

The pharma giant ($GSK) says that the mepolizumab arm in the trial scored well on the frequency of clinically significant exacerbations of asthma compared to placebo in the study. A second Phase III study (MEA115575) evaluating the use of an injection of 100 mg of mepolizumab below the skin every four weeks in comparison to placebo met the primary endpoint on reducing daily oral corticosteroid use while maintaining asthma control. As is often the case with Phase III studies, Glaxo plans to release more data at an upcoming scientific conference.

"We are really pleased to have generated further positive data on mepolizumab, consistent with the findings from our earlier exacerbation study," noted Dave Allen, the head of GSK's respiratory R&D unit, in a statement. "We now have two studies showing a reduction in exacerbations in a specific group of patients with a severe form of asthma who continue to exacerbate despite treatment with high doses of their current maintenance therapies. This is very positive news for patients. For GSK it is exciting that this is the first non-inhaled treatment for severe asthma and we will be progressing towards global filings at the end of the year."

Back in 2012, GSK reported that in a 621-patient mid-stage study, the injected candidate experienced half as many clinically significant attacks as those taking a placebo. GSK has had considerable success building up its respiratory drug portfolio over the past two years.

Glaxo has an ambitious development plan for this therapy. Just a few days ago the company announced plans to start a late-stage study of the drug in patients suffering from eosinophilic granulomatosis with polyangiitis (EGPA), which triggers an inflammatory response in small blood vessel walls, with an impact on multiple organs. The rare disease affects only about 4,300 patients in the U.S. and several European nations.

- here's the release from GlaxoSmithKline