Disappointing Phase III trial results for AZ’s Bevespi

Chronic obstructive pulmonary disease is a progressive disease that leads to the obstruction of the airways, and breathlessness. AZ’s Bevespi (glycopyrronium/formoterol fumarate), a twice daily long-acting muscarinic agonist (LAMA)/long-acting beta agonist (LABA) combination is already approved in the US and Canada for the treatment of COPD, but is yet to be approved in the EU.

In the 24 week phase III AERISTO trial involving over one thousand COPD patients, AZ’s Bevespi did not fare well against GSK’s once daily combination Anoro (umeclidinium/vilanterol). It demonstrated non-inferiority on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1, missing two of the main endpoints of the study. Colin Reisner, head of respiratory medicines development at AZ, said these phase III trial results are “inconsistent with previous data” of Bevespi and said that AZ will be looking closely at the data to work out why.