Credit: Shutterstock photoAstraZenecaAZN announced disappointing data from a phase IIIb study evaluating Bevespi Aerosphere for treating moderate to very severe chronic obstructive pulmonary disease ("COPD"). The study compared the drug to GlaxoSmithKline's GSK Anoro Ellipta (umeclidinium/vilanterol).
Data from the study showed that Bevespi Aerosphere is not inferior to Anoro Ellipta on peak forced expiratory volume in one second (FEV1), a measure of lung function. However, it failed to show superiority over Anoro Ellipta. Moreover, Bevespi Aerosphere failed to demonstrate non-inferiority over Anoro Ellipta in trough FEV1.
The 24-week phase IIIb AERISTO study evaluated Bevespi Aerosphere in patients with COPD for non-inferiority and superiority in peak FEV1 and non-inferiority alone in trough FEV1 compared to Anoro Ellipta. Patients were administered either two inhalations twice a day of Bevespi Aerosphere or one inhalation once a day of Anoro Ellipta.
Peak FEV1 is the maximum amount of air a person can forcefully exhale in one second after taking a deep breath following the administration of an inhaler. Trough FEV1 measures the same before drug administration or after a day of administration.
The press release also stated that data from the study were "inconsistent with previous data". The company is conducting a detailed analysis to understand the inconsistency and a detailed report will be presented at a future medical meeting.
Bevespi Aerosphere is a combination of a LAMA (glycopyrronium) and a LABA (formoterol fumarate) drug. The drug is marketed in the United States and Canada as long-term maintenance treatment of airflow obstruction in patients with COPD. The drug is not yet available in Europe, however, a regulatory application is under review in Europe and a decision is expected later this year.
Shares of AstraZeneca have gained 9.8% year to date versus the industry 's decline of 5.1%.
Moreover, the already crowded respiratory therapeutic area is getting more competitive with new and better drugs getting approval. Apart from the above two drugs, Novartis' NVS Utibron Neohaler ,also a two-drug combination, is approved for treating COPD. Meanwhile, Glaxo and its partner Innoviva, Inc. INVA also have a triple combination drug (ICS/LAMA/LABA), Trelegy Ellipta, in their product portfolio. AstraZeneca is also developing its triple combination candidate, PT010, for treating COPD.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
