GlaxoSmithKline commences study of hypereosinophilic syndrome therapy

GlaxoSmithKline has announced the commencement of a new study assessing the interleukin 5 antagonist mepolizumab in the treatment of severe hypereosinophilic syndrome (HES).

The 32-week study will randomise between 80 and 120 patients to evaluate the effects of mepolizumab compared to placebo, when added to the standard of care. The proportion of patients who experience a worsening of symptoms requiring escalation in therapy will be measured.

Secondary endpoints aim to demonstrate supportive evidence for the benefit of mepolizumab compared with placebo, including the time to an initial HES flare, the proportion of patients who experience a flare between week 20 and week 32, and fatigue severity.

The drug is currently approved in the EU for use as an add-on treatment for severe asthma with an eosinophilic phenotype. Data from this new study will be used to support future regulatory filings.

Steve Yancey, vice-president and medicine development leader for mepolizumab at GlaxoSmithKline, said: "The start of our phase III study is an important development in our work to explore whether mepolizumab could provide a potential alternative treatment option in this patient population."

HES is a group of inflammatory disorders affecting approximately 20,000 patients globally, characterised by a persistent and marked overproduction of a type of white blood cell, leading to inflammation and organ damage.

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