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GSK, Theravance Begin Phase II COPD Trial

GlaxoSmithKline and Theravance have initiated a Phase IIb study to evaluate the efficacy and safety of GSK961081 (‘081), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline and Theravance have initiated a Phase IIb study to evaluate the efficacy and safety of GSK961081 (‘081), in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The ‘081 compound is an investigational drug within the inhaled bifunctional muscarinic antagonist-beta2 agonist (MABA) program that Theravance licensed to GSK in 2005 under a strategic alliance.

Approximately 425 patients with moderate/severe COPD will be randomized in a multi-center, double-blind and double dummy, placebo and active-controlled, study with ‘081.

Darrell Baker, senior vice president of Respiratory & Immuno-Inflammation, Medicines Development Centre at GSK, said, “We are excited with the progress that we are making with this molecule, which has the potential to be an important new treatment option for patients living with COPD.”

Mathai Mammen, senior vice president of Research & Early Clinical Development of Theravance, said, “This MABA compound was developed through Theravance’s research of secondary binding clefts on both the beta2 and muscarinic receptors.”

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