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AZ results positive study and trial results

07 September 2017 07:49

AstraZeneca has announced that a study has shown that Duaklir significantly improves lung function in chronic obstructive pulmonary disease patients while a trial showed that tezepelumab cuts exacerbations in severe asthma.

AstraZeneca 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."

AstraZeneca and Amgen Inc announced results from the PATHWAY phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma.

Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune, AstraZeneca's global biologics research and development arm, in collaboration with Amgen. The trial results were published today in the New England Journal of Medicine, and will be followed by an oral presentation on 12 September at the ERS International Congress 2017 in Milan.

The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively (p<0.001 for all comparisons to placebo).

In the trial, tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers.

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