Top-line results from the AstraZeneca’s Phase III AMPLIFY trial for Duaklir 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, the company said Thursday. In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.
Dr. Sanjay Sethi, the lead investigator of the trial, said that the results showed 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 plans to submit an NDA during the first half of 2018 to the US Food and Drug Administration (FDA) for Duaklir, based on the AMPLIFY data.
Steve Lewington, Global Medicine Leader, Respiratory, AstraZeneca said that the AMPLIFY results give more 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.
Image: A sign is seen at an AstraZeneca site in Macclesfield, central England April 28, 2014. REUTERS/Darren Staples