Novartis has reported that Phase II data for the new inhaled combination treatment IND/GLY/MF (QVM149) demonstrated significant improvements over existing standard-of-care inhaled treatment.
The new data for QVM149, an investigational, once-daily, fixed-dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide, and mometasone furoate, was delivered with the Breezhaler inhalation device.
Novartis noted that QVM149 was superior to the comparators, salmeterol / fluticasone propionate and placebo, in two Phase II clinical trials. Separately, an improvement was seen in lung function in patients with asthma.
In one study, the treatment also demonstrated improvements versus placebo irrespective of administration time of morning or evening.
In the Phase II CQVM149B2208 study, both once-daily doses met the primary endpoint with significant improvements of peak forced expiratory volume in 1 second (FEV1) versus twice daily salmeterol / fluticasone propionate with mean differences of 172ml and 159ml.
Compared with salmeterol / fluticasone propionate 50/500 mu g twice a day, both high and medium doses of QVM149 also met the secondary endpoint with statistically significant improvements.
Novartis Respiratory Development Unit head Linda Armstrong said: “Despite the availability of numerous asthma treatments, more than one-third of asthma patients remain uncontrolled and continue to experience symptoms and / or exacerbations.
“Together with a dose-confirming Breezhaler inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve the lives of those with uncontrolled asthma.”
In the CQVM149B2209 study, the treatment provided consistent and substantial lung function benefits for 24 hours over the entire dosing interval in adult patients with asthma.
The study demonstrated the improved FEV1 for the morning and evening administrations of QVM149 compared to placebo over 14 days and met the primary endpoint.
Based on the safety data from both studies, it has been found that the treatment has a favourable safety and tolerability profile.