GSK and Theravance report positive results from Phase IIb asthma trial

Wed. December 03, 2008; Posted: 09:23 PM

Dec 03, 2008 (Datamonitor via COMTEX) -- GSK | Quote | Chart | News | PowerRating -- GlaxoSmithKline and Theravance, a biopharmaceutical company, have announced positive results from the Phase IIb study of the novel, long-acting beta agonist GW642444 in patients with moderate to severe asthma.

The study, which was designed to evaluate the efficacy of five doses of GW642444 ('444) administered once-daily for four weeks, showed dose dependent improvements in lung function. All but the two lowest doses of '444 produced statistically significant improvements (p < 0.05) in forced expiratory volume in one second (FEV1) measured 23-24 hours after the last dose in a large study population of asthmatics already being treated with inhaled corticosteroids and short acting beta agonist rescue medication as needed.

Further evidence of once-daily efficacy was observed in a number of secondary endpoints including improvements in peak expiratory flow both in the morning and evening, and the percentage of symptom-free days and rescue-free days.

Use of rescue medication was significantly lower in patients receiving the three highest doses of '444, compared to patients on placebo. Onset of action was dose-dependent with the bronchodilator effect being sustained over 24 hours. Furthermore, improvements in lung function 24 hours after the first dose were maintained throughout the 28 day treatment period, the company said.

Throughout the four week study period '444 was well tolerated at all doses and the frequency of adverse events was comparable to placebo. These data show that in asthma, '444 demonstrated statistically significant once-daily bronchodilation versus placebo and was well tolerated.

Rick Winningham, CEO of Theravance, said: "The goal of the collaboration with GlaxoSmithKline (GSK) is to develop a novel, once-a-day inhaled combination medicine comprised of a long-acting beta agonist and a corticosteroid to bring relief to patients with asthma and chronic obstructive pulmonary disease."

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For full details on GlaxoSmithKline (GSK) click here. GlaxoSmithKline (GSK) has Short Term PowerRatings of 6. Details on GlaxoSmithKline (GSK) Short Term PowerRatings is available at This Link.

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