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GSK starts phase III study on mepo

27 June 2017 15:00

GlaxoSmithKline has announced that the Company has started a phase III study with mepolizumab, an interleukin 5 (IL-5) antagonist, in patients with severe bilateral nasal polyps.

It said the study will assess the efficacy and safety of subcutaneous mepolizumab 100mg compared to placebo, administered using a pre-filled syringe every 4 weeks for 52 weeks, on top of standard of care in 400 adult patients with recurrent severe bilateral nasal polyps.

The co-primary endpoint of the study is the change from baseline in the total nasal polyps score (sum of left and right nostril score) assessed by endoscopy at week 52 and nasal obstruction, as measured using the visual analogue scale (VAS) symptom score during the four weeks prior to week 52.

The key secondary endpoint is the time to first actual surgery for nasal polyps by week 52. The study is anticipated to complete in 2019.

Steve Yancey, Vice President and Medicine Development Leader for mepolizumab, said:

"We are pleased to start this study which builds on our existing programmes to investigate mepolizumab in a range of eosinophilic diseases. In general, nasal polyps may be considered a benign disease but in severe cases it can have a significant impact on a patient's day-to-day living. Our aim is to see whether mepolizumab can improve symptoms, reduce nasal polyp size and reduce the need for surgery in these patients despite optimal medical management."

At 3:00pm: (LON:GSK) GlaxoSmithKline PLC share price was -13.75p at 1697.25p

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