Phase 3 Trial Update of QVA149 for COPD

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Sosei and Novartis announced that the first three Phase 3 studies of QVA149 (indacaterol 110mcg/glycopyrronium bromide 50mcg) in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are part of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD. IGNITE is an international patient registration program in COPD comprising 10 studies in total.

SHINE was a 26-week, multicenter, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with moderate to severe COPD assessing efficacy in terms of trough FEV1. SHINE met the primary endpoint by demonstrating the superiority in trough FEV1 (P<0.001) of once-daily QVA149 compared to once-daily indacaterol (Arcapta; Novartis) or once-daily NVA237 (glycopyrronium bromide) in patients with moderate to severe COPD. In addition, QVA149 showed superiority in trough FEV1 (P<0.001) compared to placebo and open-label tiotropium (18mcg).

BRIGHT was a three-week, randomized, blinded, double-dummy, multi-center, placebo controlled, three-period crossover pivotal trial of 85 patients with moderate or severe COPD to assess the effect on exercise tolerance of QVA149. The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo (P=0.006).

ENLIGHTEN was a 52-week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate or severe COPD to assess the safety and tolerability of QVA149. ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.

QVA149 is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237).

For more information visit www.sosei.com.

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