Phase III AMPLIFY trial of Duaklir Genuair (aclidinium bromide/formoterol) positive as a treatment for COPD.- AstraZeneca + Circassia Pharma.

AstraZeneca announced positive top-line results from the Phase III AMPLIFY trial for Duaklir Genuair (aclidinium bromide/formoterol 400�g/12�g 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 18�g once-daily. In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18�g once-daily. 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.

About AMPLIFY- AMPLIFY is a 24-week treatment, multicentre, randomised, double-blind, double dummy, parallel-group trial to assess the efficacy and safety of aclidinium bromide/formoterol 400�g/12�g twice-daily compared to its component parts (aclidinium bromide 400�g twice-daily or formoterol fumarate 12�g twice-daily) and once-daily tiotropium 18�g in moderate to very severe stable COPD patients.The primary outcome measures were to demonstrate; 1.a change from base-line morning pre-dose (trough) FEV1 for aclidinium bromide/formoterol 400�g/12�g versus formoterol 12�g at week 24. 2. a change from base-line in morning one-hour post-dose FEV1 for aclidinium bromide/formoterol 400�g/12�g versus aclidinium bromide 400�g at week 24.3. a change from baseline in morning pre-dose (trough) FEV1 at week 24 comparing aclidinium bromide 400�g versus tiotropium 18�g to demonstrate non-inferiority. Other objectives were to assess the safety of aclidinium bromide/formoterol fumarate 400�g/12�g, as well as to further characterise the effect of the combination on bronchodilation and health related quality of life.

Comment: The fixed-dose combination was approved by the European Medicines Agency (EMA) in November 2014 as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. AstraZeneca is expected to submit an NDA during the first half of 2018 to the FDA for Duaklir Genuair, based on the AMPLIFY data.

Comment:The rights to market Duaklir Genuair in the US are licensed to Circassia Pharmaceuticals.