AstraZeneca said that the 52-week Phase 3 ETHOS trial of its Breztri Aerosphere (formerly PT010) budesonide/glycopyrronium/formoterol fumarate MDI in more than 8,500 patients with moderate to very severe COPD and a history of exacerbations within the past year has met its primary endpoint.
The trial, which compared Breztri Aerosphere to Bevespi Aerosphere glycopyrronium/formoterol fumarate and PT009 budesonide/formoterol fumarate, demonstrated statistically significant reduction in moderate or severe exacerbations at both the standard dose of budesonide and at half the budesonide dose.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “Exacerbations are devastating events for patients and can lead to a permanent loss of lung function. The Phase 3 ETHOS trial builds on the Phase 3 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.”
According to the company, regulatory submissions for Breztri Aerosphere are under review in the US, EU, and China, and the MDI already been approved in Japan. PT010 was initially developed by Pearl Therapeutics which was acquired by AstraZeneca in 2013, and AstraZeneca said that approval of Breztri Aerosphere in the US would trigger a final milestone payment of $150 million in conjunction with that deal.
Read the AstraZeneca press release.
