AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg) has hit its primary endpoint in the Phase III ETHOS trial, the company has announced.
The drug – formerly known as PT010 – was analysed in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), and demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg).
In a key secondary endpoint, Breztri Aerosphere also showed a statistically-significant 52% reduction in the rate of moderate or severe COPD exacerbations compared with Bevespi Aerosphere in a patient population that was not required to have had an exacerbation in the previous 12 months.
The safety and tolerability of the triple combo was consistent with the known profiles of the dual comparators and in the trial, all combination therapies were administered in a pressurised metered-dose inhaler (pMDI) using Aerosphere delivery technology.
Exacerbations are “devastating events for patients and can lead to a permanent loss of lung function”, explained Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
He continued, “The Phase III ETHOS trial builds on the Phase III KRONOS data which together show Breztri Aerosphere’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months. We look forward to sharing these results with health authorities as soon as possible.”
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and is predicted to be the third leading cause of death by 2020.