GSK runs to PhIII with upbeat data on drug for severe asthma

GlaxoSmithKline ($GSK) generated positive results from a mid-stage trial for its experimental drug in patients with an uncommon form of asthma, giving the London drug giant confidence in advancing the program to Phase III development before the end of the year, Reuters reported. And early success of the antibody drug mepolizumab fuels Glaxo's efforts to roll ahead with multiple next-generation respiratory treatments.

The company already boasts the largest respiratory business in the world, the news service reports, led by mega-blockbuster sales of Advair. Not expected to be as big of a hit, mepolizumab blocks interleukin-5 to stymie the numbers of troublesome white blood cells called eosinophils that are implicated in about 4% of asthma cases. The candidate could provide GSK with a new product to treat these tricky cases of the breathing disorder, and it could beef up its leading status in the respiratory field, even if the market for the form of asthma isn't huge.

In the 621-patient study, those on GSK's injected candidate experienced half as many clinically significant attacks as those on placebo, Reuters reported. The results are disclosed today in The Lancet, coming out as the company gears up for the last of three phases of human testing typically required to seek market approval of a drug. Last month GSK and partner Theravance ($THRX) raced ahead with submissions for approval of their potential COPD/asthma drug in the U.S. and Europe.

Asthma could be the right market for mepolizumab, for which GSK scrapped development in 2009 for a rare blood disorder called hypereosinophilic syndrome after EU regulators asked for more data.

"It seems to be a safe and effective treatment option for patients with eosinophilic asthma that is associated with frequent flare-ups, and may reduce the need for conventional treatment with oral corticosteroids that can have serious side effects including osteoporosis, high blood pressure and impaired growth in children," Ian Pavord from Britain's University Hospitals of Leicester National Health Service Trust, who led a mid-stage study of the medicine, said, as quoted by Reuters.

- check out the Reuters article