Novartis reported that the first clinical trial in its Phase III PLATINUM programme for QMF149 has met primary and key secondary endpoints in people with inadequately controlled asthma.
Known as QUARTZ, the double-blind, randomised, multi-centre Phase III trial assessed the safety and efficacy of QMF149 in 802 participants.
QMF149 is an investigational, once-daily, fixed-dose combination of long-acting beta-agonist (LABA) indacaterol acetate and anti-inflammatory mometasone furoate.
Results showed that low doses of QMF149 led to statistically significant and clinically meaningful improvements in lung function and asthma control, when compared to an inhaled corticosteroid (ICS) monotherapy of mometasone furoate after 12 weeks of therapy in both adult and adolescent patients.
QMF149 and the ICS monotherapy were generally well-tolerated during the study, with the overall incidence of adverse events (AE) being lower in the QMF149 arm versus the mometasone furoate group.
The majority of AEs were found to be mild to moderate in severity, and were comparable between treatment groups.
Severe AEs were reported in seven patients in the QMF149 group, compared to 14 subjects treated with the monotherapy.
Novartis respiratory development unit head Linda Armstrong said: “Despite the number of available treatments, many patients' lives remain impacted by their asthma.
“The QMF149 results of the QUARTZ study complement the recently presented Phase II data of QVM149 at the 2019 American Thoracic Society Congress, showing the superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial programme.”
Novartis is currently developing QMF149 to treat inadequately controlled asthma. The European Medicines Agency (EMA) recently agreed to review the therapeutic.
Novartis exclusively licensed mometasone furoate from a Merck subsidiary for use in QMF149.