Novartis’ IND/MF drug achieves endpoints in Phase III study

Allie Nawrat 31 May 2019 (Last Updated May 31st, 2019 11:39)

Swiss drug maker Novartis has announced its investigational, combination asthma drug QMF149 met both its primary and secondary endpoints in the Phase III QUARTZ trial.

Novartis’ IND/MF drug achieves endpoints in Phase III study
QMF149 combines a long-acting beta antagonist with an anti-inflammatory drug. Credit: FSP Vintage Collection.

Swiss drug maker Novartis has announced its investigational, combination asthma drug QMF149 met both its primary and secondary endpoints in the Phase III QUARTZ trial.

QMF149 is a once-daily, low dose combination treatment containing indacaterol acetate (ICD), a long-acting beta agonist, and mometasone furoate (MF), an anti-inflammatory.

In the QUARTZ trial, which is part of Novartis’ PLATINUM development programme, QMF149 was compared to MF alone in patients with inadequately controlled asthma on a low dose of anti-inflammatory drugs. QMF149 was administered using the Breezhaler device, while the control was administered through the Twisthaler device.

QMF149 demonstrated a statistically significant improvement in lung function measured by FEV1, or forced expiratory volume, and in asthma control as measured by a seven-point asthma control questionnaire (ACQ-7) after 12 weeks of treatment.

These results were confirmed by improvements in evening peak expiratory flow for the QMF149 group, compared to MF alone, as well as by ACQ-7 responder analysis.

Both QMF149 and MF were well tolerated, but the incidence of adverse events was slightly lower for the IND/MF group; 32.3% versus 38.3% respectively

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 superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.”

QVM149 is a triple combination therapy of ICD, MF and glycopyrronium bromide also being investigated in the PLATINUM programme.

Regulatory submissions for both QMF149 and QVM149 have been sent to the European Medicines Agency.