AstraZeneca has announced mixed top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
In the trial, Bevespi Aerosphere (glycopyrronium/formoterol fumarate) showed non-inferiority to umeclidinium/vilanterol (GSK’s Anoro Ellipta) on peak forced expiratory volume in one second (FEV1), but failed to demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.
“The efficacy and safety of Bevespi Aerosphere has been established by the Phase III PINNACLE trial programme involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data,” said Dr Colin Reisner, head of respiratory, Global Medicines Development, commenting on the findings.
“A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting,” he added.
Bevespi Aerosphere is a fixed-dose dual bronchodilator combining glycopyrronium, a long-acting muscarinic agonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA).
The therapy is approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD, and is also currently under review in Europe with a regulatory decision anticipated in the second half of this year.
Move to Cambridge delayed
Meanwhile, according to various media reports, AZ is unlikely to move into its new site in Cambridge, UK, until 2020, due to changing contractors.
“Following a transition period, we will be able to communicate an update as to when we can commence occupation of the facility. At the moment, this points to the first half of 2020," Reuters reported a spokesperson as saying.
The company initially planned to move in in 2016, which was then put back to the end of 2017. Last year it said the cost of its new headquarters and research site would likely overshoot $500 million.