GlaxoSmithKline has announced the commencement of a phase III clinical trial assessing the safety and efficacy of its interleukin 5 antagonist therapy mepolizumab.
The SYNAPSE trial will evaluate the effectiveness of subcutaneous mepolizumab administered using a pre-filled syringe every four weeks for 52 weeks, in addition to the current standard of care, in 400 adult patients with recurrent severe bilateral nasal polyps.
“GlaxoSmithKline has commenced a phase III clinical trial assessing the drug mepolizumab as a treatment for severe bilateral nasal polyps.“
This chronic inflammatory disease of the sinuses leads to soft tissue growth in the upper nasal cavity, impacting a patient's quality of life due to nasal obstruction, loss of smell, facial pain and nasal discharge.
Currently, this condition is generally treated with corticosteroids or surgery to remove the polyp tissue, but because polyps have a strong tendency to recur, patients often require repeat surgery.
Steve Yancey, vice-president and medicine development leader for mepolizumab at GlaxoSmithKline, said: "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."
Mepolizumab has been developed for the treatment of diseases driven by inflammation caused by eosinophils. It is currently approved for the treatment of severe eosinophilic asthma and is sold under the brand name Nucala.
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