Phase II data annonuced for once-daily, fixed dose combination asthma treatment

Novartis announced that new phase II data for IND/GLY/MF (QVM 149), an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate, delivered with the dose-confirming Breezhaler inhalation device, was presented at the 2019 annual international congress of the American Thoracic Society (ATS).

In two phase II clinical studies, IND/GLY/MF was superior to the comparators, salmeterol/fluticasone propionate (a standard-of-care treatment) and placebo, separately by demonstrating improvement in lung function in patients with asthma. In one study, IND/GLY/MF also demonstrated improvements versus placebo irrespective of administration time of morning or evening. In the phase II CQVM149B2208 study (ClinicalTrials.gov Identifier: NCT03063086) , both once-daily doses of IND/GLY/MF (150/50/160 Mu g, high-dose ICS; 150/50/80 Mu g, medium-dose ICS) met the primary endpoint with statistically significant improvements of peak FEV1 (forced expiratory volume in 1 second) versus twice daily salmeterol/fluticasone propionate (50/500 Mu g, high-dose ICS) with mean differences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively (p<0.001). 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 FEV1AUC5min-1h and FEV1AUC5min-23h45min.

In the 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.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) and salmeterol/fluticasone propionate (CQVM149B2208) , 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.