GSK severe asthma drug progresses to Phase III
pharmafile | August 20, 2012 | News story | Research and Development, Sales and Marketing | Advair, GSK, Phase II, asthma, phase III
GlaxoSmithKline’s severe asthma drug mepolizumab has impressed in a mid-stage study, meaning it can now progress into Phase III testing.
The Phase IIb DREAM study was testing mepolizumab in patients with severe eosinophilic asthma, a condition where organs are damaged by the over-production of white blood cells.
The year-long study, which involved 621 patients, found the number of clinically significant exacerbations in patients on GSK’s drug – that is defined as episodes requiring oral corticosteroids or a hospital visit – was around half compared to placebo.
The drug is a once-monthly injectable monoclonal antibody that works against interleukin 5. But mepolizumab has seemingly not been a high priority for GSK as it has been in Phase II trials since 1998.
This is because only 4% of asthmatics have the disease, meaning it will most likely not be a major seller for the firm.
The results were published in The Lancet this week in which the journal concludes that the drug: “Is an effective and well tolerated treatment that reduces the risk of asthma exacerbations in patients with severe eosinophilic asthma”.
Ian Pavord from Britain’s University Hospitals of Leicester NHS Trust, who led a mid-stage study of the medicine, said: “It seems to be a safe and effective treatment option for patients with eosinophilic asthma that is associated with frequent flare-ups.”
He added that it could also reduce the need for conventional treatment with oral corticosteroids, a good thing in his opinion as these can have serious side effects including osteoporosis, high blood pressure and impaired growth in children.
It will now progress into Phase III studies by the end of the year. If approved, the drug will be competing with Novartis’ ageing monoclonal antibody Xolair (omalizumab), which is also approved for the more severe types of asthma, and made $478 million last year.
Teva’s Cinquil is the most advanced antibody in development for this disease, with Phase III data expected to emerge possibly by the end of 2012 – AstraZeneca’s benralizumab may also report its Phase II data later this year.
GSK will hope that the drug could go some way to offsetting the upcoming patent loss of its asthma and COPD drug Seretide/Advair, which made £5 billion last year, making it the firm’s biggest seller.
The firm is planning a follow up to this drug with its Relovair treatment, which GSK and partner Theravance filed with European and US regulators for COPD last month.
But recent Phase III trials failed to show that Relovair was better than Advair, casting some doubt on its sales potential.
Ben Adams
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