Novartis has unveiled data from three late-stage studies which show that its chronic obstructive pulmonary disease drug QVA149, developed with the UK's Vectura, met all primary endpoints.
The first Phase III trial, SHINE, looked at a once-daily dose of QVA149, which is a combination of Novartis' own Onbrez Breezhaler (indacaterol), a long-acting beta 2-agonist (LABA) and NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA). Data from the 2,100-patient trial showed the combo's superiority compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD.
The BRIGHT study showed that patients had a significantly better exercise endurance versus placebo, while the ENLIGHTEN trial demonstrated that QVA149 was well tolerated and had a safety and tolerability profile similar to placebo.
These three trials are part of the IGNITE programme which comprises ten studies in total and the first seven are expected to complete this year. Included in the programme is a head-to-head trial versus GlaxoSmithKline's market-leading Seretide (salmeterol and fluticasone), which is also expected to complete during the second quarter of 2012 and will be incorporated into regulatory filings.
Observers are excited about QVA149, as it could be the first once-daily LAMA/LABA combo to come to market for COPD.