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news.GlaxoSmithKline (GSK) and Theravance have started treatment with GSK961081 ('081) in a multi-centre, randomised, double-blind and double dummy, placebo and active-controlled, eight-arm, parallel-group study Phase IIb study to evaluate efficacy and safety in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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‘081 is a single molecule functioning as both a muscarinic antagonist and a beta2 receptor agonist (MABA).
‘081 is an investigational compound within the inhaled bifunctional muscarinic antagonist-beta2 agonist (MABA) programme that was licensed to GSK from Theravance in 2005 under the terms of the companies’ strategic alliance agreement.
The overall aim of this Phase IIb study is to evaluate the safety and efficacy of ‘081 administered both once daily, QD and twice daily, BID, over a 28 day period to allow the selection of a well tolerated and efficacious dose and dosing interval to take forward into Phase III development.
Theravance Research & Early Clinical Development SVP Mathai Mammen said this MABA compound was developed through Theravance’s research of secondary binding clefts on both the beta2 and muscarinic receptors.