AstraZeneca has reported positive top-line results from the Phase III PINNACLE 4 clinical trial of Bevespi Aerosphere to treat moderate to very severe chronic obstructive pulmonary disease (COPD).
The results showed statistically significant improvement in lung function compared with twice-daily placebo and monotherapy components, 14.4µg of glycopyrronium and 9.6µg of formoterol fumarate.
Bevespi Aerosphere is a fixed-dose dual bronchodilator comprising a combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA), and long-acting beta-2 adrenergic agonist (LABA) formoterol fumarate.
The PINNACLE 4 trial evaluated the safety and efficacy of twice-daily Bevespi Aerosphere administered through pressurised metered-dose inhaler (pMDI) in 1,756 subjects over 24 weeks in Asia, Europe and the US.
AstraZeneca Global Medicines Development Respiratory head Dr Colin Reisner said: “These positive results add to the strong established efficacy and safety profile of Bevespi Aerosphere in the treatment of patients with COPD.
“PINNACLE 4 will support our regulatory filings in Japan and China where respiratory diseases such as COPD remain a significant and growing public health burden with unmet treatment needs.”
The primary outcome of the Phase III trial was the change in morning pre-dose from baseline, while secondary outcomes were dyspnoea, health-related quality of life, time to onset and use of rescue medication.
It was observed that the safety and tolerability data for Bevespi Aerosphere in the PINNACLE 4 trial was consistent with the findings from previous trials.
The firm intends to carry out the regulatory filings for the drug in Japan and China next year.