AstraZeneca has announced positive top-line results from the phase III AMPLIFY trial for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (either aclidinium bromide or formoterol). In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.

Dr. Sanjay Sethi, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine at University at Buffalo, The State University of New York, USA and the lead investigator of the trial, said: “These results demonstrate the improvement in lung function achieved by the combination of aclidinium and formoterol compared to single LAMA bronchodilators tiotropium and aclidinium, with comparable safety.”

The efficacy, safety and tolerability profiles for aclidinium bromide and formoterol were consistent with current experience. A full evaluation of the AMPLIFY data is ongoing and further results will be presented at a forthcoming medical meeting. AstraZeneca is expected to submit an NDA during H1 2018 to the US Food and Drug Administration (FDA) for Duaklir, based on the AMPLIFY data.

Steve Lewington, Global Medicine Leader, Respiratory, AstraZeneca said: “The AMPLIFY study top-line results provide further clinical evidence of Duaklir's efficacy and support making this LAMA/LABA combination treatment option available to COPD patients in the US.”

In April 2017 AstraZeneca entered a strategic collaboration with Circassia Pharmaceuticals plc (Circassia) for the development and commercialisation of Tudorza and Duaklir in the US. Under the terms of the collaboration, Circassia was granted the rights to Duaklir in the US. Circassia is also leading the promotion of Tudorza in the US and was conferred an option to gain full commercial rights in the future.