GSK and Theravance announce completion of the Phase III programme for once-daily LAMA/LABA in COPD

GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the completion of the phase III programme of an investigational LAMA/LABA involving approximately 6,000 patients with chronic obstructive pulmonary disease (COPD).

LAMA/LABA is a combination of two investigational bronchodilator molecules – GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA™ inhaler. UMEC/VI is a once-daily investigational medicine currently under development for the maintenance treatment of COPD.

On 2 July 2012, GSK and Theravance announced the completion of four pivotal studies for UMEC/VI. The pivotal programme for UMEC/VI also includes a 52-week safety study, which is now complete. Two non-pivotal 12-week crossover exercise studies will also be included in the registrational package as they are now also complete. These recently completed studies support GSK’s plans to commence global regulatory submissions for UMEC/VI from the end of 2012.

The full results of all these studies, together with additional data from phase IIb dose-ranging studies of UMEC, will be presented at future scientific meetings.

About the LAMA/LABA Studies

The 52-week parallel group safety study evaluated the long-term safety and tolerability of UMEC 125mcg alone and the combination UMEC/VI 125/25mcg compared to placebo in approximately 500 patients. The two replicate 12‑week crossover exercise studies of approximately 300 patients each, evaluated the lung function and exercise endurance time of UMEC/VI 125/25mcg and 62.5/25mcg, UMEC 125mcg and 62.5mcg, and VI 25mcg compared to placebo. The co-primary endpoints of these studies were 3‑hour post-dose exercise endurance time and trough FEV1.

Other respiratory development programmes

The data from these studies will also contribute to the future regulatory submissions for GSK’s UMEC monotherapy, with global filings commencing in 2013.

UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR™ and BREO™), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK’s investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.