Theseus Pharmaceuticals Inc (THRX)

[surf1944]

:58AM GSK and Theravance (THRX) announced the results of Phase III studies of investigational LAMA/LABA; for the first treatment comparison showed a statistically significant improvement (GSK) 45.58 : GlaxoSmithKline (GSK) and Theravance (THRX) announced the results of four pivotal phase III studies of investigational LAMA/LABA involving over 4,000 patients with chronic obstructive pulmonary disease. These four studies include two 24-week efficacy studies that compared the combination LAMA/LABA, its components and placebo and two 24-week active comparator studies that compared the combination with the LAMA tiotropium, a widely prescribed maintenance bronchodilator for COPD. The second 24-week, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of UMEC/VI 62.5/25mcg and 125/25mcg with UMEC 125mcg and tiotropium 18mcg. This study randomised 872 patients. The pre-specified primary endpoint was trough FEV1 at the end of the treatment period. For the first treatment comparison, UMEC/VI 125/25mcg showed a statistically significant improvement of 74mL compared with tiotropium. For the second comparison, UMEC/VI 125/25mcg showed a numerical but not statistically significant improvement compared with UMEC 125mcg. UMEC/VI 62.5/25mcg showed a numerical difference from tiotropium of 60mL and a numerical difference from UMEC 125mcg of 22mL in trough FEV1.