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GSK starts trial of Nucala to seek alternate indications

Asthma therapy drug to be used to target severe nasal polyposis

GSK

GlaxoSmithKline's quest to find indications for its severe asthma therapy Nucala has taken a new turn, with the company now targeting severe nasal polyposis.

Millions of people around the world are thought to have nasal polyps - teardrop-shaped swellings of the nasal lining that seem to be caused by chronic inflammation - and while they are often symptomless, in some people they can have a big impact on quality of life. At the moment they are treated with intranasal corticosteroids and surgery for severe cases.

Symptoms can include blocked and runny nose, loss of smell or taste, facial pain, snoring and obstructive sleep apnoea, and polyps increase the risk of infections and sinusitis. It is estimated that 20-40% of people with nasal polyps also have asthma.

Nucala (mepolizumab) is an interleukin-5 inhibitor that was approved for severe eosinophilic asthma in 2015 and is also in clinical trials for other diseases thought to be linked to elevated levels of eosinophil white cells - including chronic obstructive pulmonary disease (COPD), severe atopic dermatitis, hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis.

Last month, GSK reported mixed results for the drug in COPD patients, putting the prospects for that programme in doubt.

GSK reported sales of £59m ($76m) for Nucala in the first quarter of the year, more than double the same period of last year, but the company needs to rack up additional indications for the drug if it is to meet analysts' projections of $1bn-plus in peak sales.

The drug was the first in the IL-5 inhibitor class to reach the market but is now facing competition from Teva's Cinqaero (reslizumab), while the class could see a third entrant in the form of AstraZeneca's benralizumab later this year.

The new trial will compare a monthly subcutaneous dose of mepolizumab to placebo, given on top of standard of care over one year in 400 adult patients with recurrent severe bilateral nasal polyps. The main outcome measure will be the volume of polyps in the nasal passages, while a secondary endpoint will be the time to first surgery.

"This study … builds on our existing programmes to investigate mepolizumab in a range of eosinophilic diseases," said Steve Yancey, who is leading the development programme for mepolizumab at GSK.

"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."

Article by
Phil Taylor

28th June 2017

From: Research

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