GlaxoSmithKline and Theravance, have started large Phase 2b asthma dose-optimization studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon' program to develop a next-generation combination product.

GSK had enrolled patients with mild to severe asthma in the '698 Phase 2b clinical program on 21st December 2007 and patients with persistent asthma in the '444 Phase 2b clinical program on 29th December 2007. These clinical programs will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD program with '444 is also on schedule to commence in 1H 2008.

These studies will enroll in excess of 2,400 patients recruited globally. The '444 LABA Phase 2b dose-optimization study will enroll approximately 600 patients with persistent asthma who are receiving inhaled steroids. The '698 ICS Phase 2b 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. In parallel, enabling studies involving '444 and '698 given in combination will be undertaken prior to commencing large-scale Phase 3 combination studies.

In a recently completed Phase 2 study, '698 demonstrated once-a-day efficacy in patients with moderate asthma, with significant improvements in lung function in excess of 200mL seen within the first two weeks of dosing and maintained throughout the remainder of the 8 weeks treatment period, without any adverse effect on adrenal function (a marker of systemic steroid effect).

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction.