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

Novartis International AG / Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• New inhaled combination for asthma treatment (indacaterol acetate, glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior to the standard of care (long-acting beta-agonist/inhaled corticosteroid - LABA/ICS) in terms of lung function in a phase II study
   

In another phase II study, IND/GLY/MF was superior to placebo in lung function improvement irrespective of administration time of morning or evening
 

The combination of IND/GLY/MF is in development as a once-daily inhaled treatment for asthma, delivering the comprehensive bronchodilation of indacaterol/glycopyrronium and the established efficacy of mometasone via the dose-confirming Breezhaler
 

IND/GLY/MF demonstrated a favorable safety and tolerability profile in both phase II studies

Basel, May 22, 2019 - Novartis announced today that new phase II data for IND/GLY/MF (QVM149), 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)[1] and placebo[2], 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[2].

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)[1].