Novartis Announces Positive Phase II Results for QVM149, a Novel Triple Combination Therapy Demonstrating Superior Lung Function Improvement Over Standard of Care in Asthma Patients

Today, Novartis announced that QVM149, a combination therapy developed by the company, significantly improved lung function in patients with asthma in a Phase 2 clinical trial, outperforming common standard therapies. The therapy is currently being evaluated in Phase 3 clinical trials and is expected to deliver top-line results this year.

Asthma affects the lives of 358 million people worldwide. If symptoms are not controlled, it will bring serious personal, health, and economic burdens to patients. Although various asthma therapies have been approved, more than one-third of asthma patients still have uncontrolled symptoms.

QVM149, developed by Novartis, is a fixed-dose combination product comprising three active ingredients: a long-acting muscarinic antagonist (glycopyrronium bromide), a long-acting β2-adrenergic agonist (indacaterol), and an inhaled corticosteroid (mometasone furoate). According to Dr. Vas Narasimhan, CEO of Novartis, this drug is a potential blockbuster candidate that Novartis plans to launch in 2020.

In a randomized, double-blind, active-controlled Phase 2 clinical trial, patients with moderate-to-severe asthma received either different doses of QVM149 or the standard therapy—salmeterol/fluticasone propionate combination. The trial results demonstrated that QVM149 met the primary endpoint compared with the active control group, significantly improving forced expiratory volume in one second (FEV1). Compared with the active control, two different doses of QVM149 increased FEV1 by 172 mL and 159 mL, respectively (p<0.001).

“These results indicate that the innovative combination of two bronchodilators and an inhaled corticosteroid can further improve lung function in asthma patients beyond existing therapies,” said Dr. Henrik Watz from the German Center for Lung Research.

“Despite the availability of numerous asthma therapies, symptoms remain uncontrolled in more than one-third of patients with asthma,” said Dr. Linda Armstrong, Head of Respiratory Development at Novartis. “The data from these Phase 2 clinical studies represent a significant advance in the development of this innovative combination. If approved, it could improve the lives of patients whose asthma symptoms are not yet adequately controlled.”

References:

[1] Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment. Retrieved May 22, 2019, from https://www.globenewswire.com/news-release/2019/05/22/1840512/0/en/Novartis-phase-II-data-for-new-inhaled-combination-treatment-QVM149-demonstrates-significant-improvements-over-current-standard-of-care-inhaled-treatment.html

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