The new phase 2 data for an investigational once-daily, fixed dose combination currently in development for the treatment of inadequately controlled asthma was presented at the 2019 Annual International Congress of the American Thoracic Society (ATS) in Dallas.
Data from a pair of phase 2 clinical studies showed the investigational combination treatment of indacaterol acetate, glycopyrronium bromide, and mometasone furoate (IND/GLY/MF, Novartis),demonstrated superiority in improving lung function in patients with asthma when compared with salmeterol/fluticasone propionate and placebo.
The investigational therapy also demonstrated improvements versus placebo irrespective of administration time of morning or evening, in 1 study, which was presented at the 2019 Annual International Congress of the American Thoracic Society (ATS) in Dallas.
In the phase 2 CQVM149B2208 study, both once-daily doses of IND/GLY/MF (150/50/160 Mu g, high-dose ICS; 150/50/80 Mu g, medium-dose ICS), delivered with Novartis’ dose-confirming Breezhaler inhalation device, 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< .001).
Additionally, compared with salmeterol/fluticasone propionate twice a day, both high and medium doses of IND/GLY/MF met the secondary endpoint with statistically significant improvements (P <.001) in FEV1AUC (FEV1 area under the curve) across both time intervals of FEV1AUC5min-1h and FEV1AUC5min-23h45min.
In study CQVM149B2209, 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 during any treatment period in both studies.
While phase 3 trials are ongoing, Novartis announced plans to present more data and analyses at future medical conferences to address the clinical and regulatory path forward for IND/GLY/MF.
Asthma affects an estimated of 358 million people worldwide. The condition can cause a significant personal, health, and financial burden when not adequately controlled, according to Novartis.
Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment [news release]. Basel, Switzerland; May 22, 2019: Novartis. https://www.novartis.com/news/media-releases/novartis-phase-ii-data-new-inhaled-combination-treatment-qvm149-demonstrates-significant-improvements-over-current-standard-care-inhaled-treatment. Accessed May 22, 2019.