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news.GlaxoSmithKline and Theravance have reported the start of large Phase IIb asthma dose-optimization studies with both the lead inhaled corticosteroid GW685698 and the lead long-acting beta agonist GW642444 assets in the 'Horizon' program to develop a next-generation combination product.
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These studies will enroll in excess of 2,400 patients recruited globally. The GW642444 long-acting beta agonist (LABA) Phase IIb dose-optimization study will enroll approximately 600 patients with persistent asthma who are receiving inhaled steroids.
The GW685698 inhaled corticosteroid (ICS) Phase IIb studies will be undertaken in three separate studies in mild, moderate and severe asthma patients with a total enrollment of 1,800 patients. All studies will be carried out using a new inhaler device.
Darrell Baker, senior vice president of GlaxoSmithKline respiratory medicines development center, said: “The program is progressing well and we are delighted to have two very strong assets to progress into our large Phase IIb studies. Our goal will be to offer patients the benefit of a once-daily medication to address a significant unmet patient need.”