AstraZeneca's Breztri meets all primary endpoints in asthma trials

(Sharecast News) - AstraZeneca announced on Friday that its inhaled triple-combination therapy 'Breztri Aerosphere' met all primary endpoints in two phase three trials, delivering statistically significant and clinically meaningful improvements in lung function for patients with uncontrolled asthma. The FTSE 100 pharmaceuticals giant said the KALOS and LOGOS studies, which were randomised, double-blind, and replicate in design, assessed Breztri against standard dual inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapy.

It said the trials demonstrated that Breztri, which combines budesonide, glycopyrronium and formoterol fumarate, outperformed dual therapy in improving lung function in adults and adolescents whose asthma remained uncontrolled despite maintenance treatment.

No new safety or tolerability issues were identified in either study.

AstraZeneca said the full results would be submitted to regulatory authorities and presented at an upcoming medical conference.

Breztri is already approved for the treatment of chronic obstructive pulmonary disease in more than 80 countries, including the US, EU, China and Japan.

The company highlighted the potential for the therapy to address a significant unmet need in asthma care, noting that nearly half of all asthma patients on dual therapy continue to experience symptoms and impaired lung function.

"We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma," said Sharon Barr, AstraZeneca's executive vice-president of biopharmaceuticals research and development.

"These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients."

At 0946 BST, shares in AstraZeneca were up 0.3% at 10,640p.

Reporting by Josh White for Sharecast.com.