AstraZeneca (AZN -3.8%) announces positive results from a Phase 3 clinical trial, ETHOS, evaluating Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The data were presented virtually at the American Thoracic Society Scientific Symposium, Clinical Trials in Pulmonary Medicine and published in the New England Journal of Medicine.
Treatment with the inhalable triplet therapy resulted in a statistically significant reduction in exacerbations compared to two dual-combo therapies.
Specifically, patients receiving Breztri Aerosphere experienced 24% fewer exacerbations compared to Bevespi Aerosphere (glycopyrronium/formoterol fumarate) which showed 13% fewer exacerbations compared to PT009 (budesonide/formoterol fumarate). The doublet therapies were comparators.
Breztri Aerosphere demonstrated a 46% reduction in the risk of all-cause mortality versus Bevespi Aerosphere, a key secondary endpoint.
The triplet therapy is currently approved for COPD in Japan and China. Marketing applications in the U.S. and Europe are currently under review.
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