Investigational Inhalational Therapy Shows Benefits Over Standard Asthma Treatment in Study

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 FEV₁AUC_5min-1h and FEV₁AUC_{5min-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.

Reference

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.