Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment - Seite 2

Additionally, compared with salmeterol/fluticasone propionate 50/500 Mu g twice a day, both high and medium doses of IND/GLY/MF met the secondary endpoint with statistically significant improvements (p<0.001) in FEV₁AUC (FEV₁ area under the curve) across both time intervals of FEV₁AUC_5min-1h and FEV₁AUC_{5min-23h45min}[1].

"These results demonstrate that this novel combination offering dual bronchodilation plus an inhaled corticosteroid can provide further lung function benefits to patients with asthma beyond established therapies," said Dr Henrik Watz, Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research.

In study CQVM149B2209 (ClinicalTrials.gov Identifier: NCT03108027), once-daily IND/GLY/MF provided consistent and substantial lung function benefits over the entire 24-hour dosing interval in adult patients with asthma, irrespective of dosing time (morning or evening). The study met the primary endpoint by demonstrating the improved FEV₁ for both morning and evening administrations of IND/GLY/MF versus placebo over 14 days, with mean differences of 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) respectively[2].

The safety data from both studies suggest that IND/GLY/MF has a favorable safety and tolerability profile. The adverse events observed in the IND/GLY/MF groups were comparable to placebo (CQVM149B2209)[2] and salmeterol/fluticasone propionate (CQVM149B2208) [1], with no serious adverse events reported in any treatment period in both studies.

While phase III trials are ongoing, Novartis plans to present more data and analyses at future medical conferences to address the clinical and regulatory path forward for IND/GLY/MF delivered by Breezhaler.

"Despite the availability of numerous asthma treatments, more than one-third of asthma patients remain uncontrolled and continue to experience symptoms and/or exacerbations," said Linda Armstrong, MD, Respiratory Development Unit Head. "These phase II studies' results are a promising stride forward for this once daily combination. Together with a dose-confirming Breezhaler inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve lives of those with uncontrolled asthma."