Sosei Group has announced that the QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, has met its primary endpoint of reducing exacerbations in COPD patients, compared to glycopyrronium bromide.
The multi-centre, randomised, double-blind study demonstrated that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations, compared to patients treated with QD glycopyrronium 50mcg.
The moderate-to-severe exacerbation rate was numerically lower in patients on QVA149 compared to open-label (OL) tiotropium 18mcg.
Sosei CEO Shinichi Tamura said the study demonstrated a meaningful reduction in exacerbations in COPD patients.
"We look forward to more detailed data from both glycopyrronium bromide (NVA237) and QVA149 at the upcoming European Respiratory Society meeting in Vienna in early September with the first filings for QVA149 expected in Europe and Japan by the end of this year," Tamura said.
The parallel-group, active controlled study reported that QVA149 was statistically more effective in reducing the overall rate of all exacerbations, compared to glycopyrronium 50mcg and OL tiotropium 18mcg.
A similar adverse event profile of QVA149 and glycopyrronium 50mcg and OL tiotropium 18mcg was reported.
The company expects the results of SPARK, the final study intended for initial regulatory filings of QVA149 in Europe and Japan, in the fourth quarter of 2012.