QVM149 is a combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate, which was delivered with the dose-confirming BreezhalerIGB gas pipeline inhalation device during the mid-stage trials.
The investigational, once-daily, fixed dose combination asthma treatment was found to be superior to standard-of-care treatment salmeterol/fluticasone propionate and placebo by improving lung function in the participants.
In one of the studies, QVM149 also achieved improvements irrespective of time of administration, whether it was morning or evening, when compared to placebo.
In the phase 2 CQVM149B2208 trial held in 116 patients, the investigational asthma treatment achieved the primary endpoint by showing statistically significant improvements of peak forced expiratory volume in one second. This was in comparison to daily twice salmeterol/fluticasone propionate.
In the other phase 2 study, called CQVM149B2209 held in 37 patients, the investigational treatment gave consistent and substantial lung function benefits throughout the entire 24-hour dosing interval in adult patients with asthma, said Novartis.
The mid-stage trial met its primary endpoint as well by improving forced expiratory volume in one second for morning and evening administrations. This was in comparison to placebo for a period of 14 days.
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.
“These phase II studies’ results are a promising stride forward for this once daily combination. Together with a dose-confirming BreezhalerIGB gas pipeline inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve lives of those with uncontrolled asthma.”
Earlier this month, Novartis signed a deal with Japanese pharma giant Takeda to acquire its dry eye drug Xiidra (lifitegrast ophthalmic solution) 5% for $3.4bn (£2.69bn) along with an additional $1.9bn (£1.5bn) in potential milestone payments.
Xiidra has approvals for the treatment of signs and symptoms of dry eye disease in the US, Canada, Australia and other markets.