Novartis' asthma combo tops standard of care in phase 3

Novartis headquarters
After 12 weeks of treatment, the Novartis combo beat the steroid at increasing lung function, as measured by the amount of air a person can exhale in one second after taking a deep breath. (Novartis)

Novartis’ asthma treatment combining a long-acting beta agonist (LABA) with an inhaled corticosteroid improved lung function better than the corticosteroid alone, phase 3 data show. The study tested the combo, dubbed QMF149, in more than 800 patients who still had asthma symptoms despite taking medication to control them. 

QMF149 combines the corticosteroid mometasone furoate—commonly used to control asthma—with the LABA indacaterol acetate and is delivered using Novartis’ Breezhaler device. Before the trial started, all of the patients took low-dose corticosteroids for at least a month, followed by fluticasone proprionate—one half of GlaxoSmithKline’s blockbuster Advair. About half of the 802 patients received QMF149 daily, while the other half were treated with mometasone furoate alone. 

After 12 weeks of treatment, the combo beat the steroid at increasing lung function, as measured by FEV1, the amount of air a person can exhale in one second after taking a deep breath. QMF149 also outperformed the steroid at improving patients’ asthma control, according to a questionnaire that considers symptoms, use of a rescue inhaler and FEV1. 

"I am very pleased with the results of the QUARTZ study looking at the efficacy and safety of the fixed dose combination of indacaterol and mometasone furoate," Dr. Oliver Kornmann of the University Hospital Mainz in Germany said in a statement. "Fixed-dose combination inhalers may offer advantages to people with asthma by simplifying complex inhaler regimens, especially when they can be dosed once daily which can therefore further reduce the burden of the disease." 

RELATED: Novartis' asthma triplet beats GSK's Advair in phase 2 trial 

Combining LABAs with corticosteroids to treat asthma isn’t a new idea—after all, it’s what made Advair so successful. Advair now faces generic competition, but Novartis could still get a piece of the pie if it can deliver a product that outdoes it. And just last week, the Big Pharma reported data that showed it just might. 

Novartis is developing another asthma combo based on QMF149. This triplet, known as QVM149, adds a long-acting muscarinic antagonist to QMF-149's corticosteroid-LABA backbone. In a phase 2 study presented at the 2019 annual international congress of the American Thoracic Society, two once-daily doses of QVM149 beat Advair at improving lung function in patients with uncontrolled asthma. 

The company also reported data from a second trial that assessed whether the effect of QVM149 changes depending on the time of day the drug is given. QVM149 bested placebo regardless of whether it was administered in the morning or evening.