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AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) has met the primary endpoints in two Phase III asthma trials.
Breztri met primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines, in the Phase III KALOS (NCT04609878) and LOGOS (NCT04609904) trials in patients with uncontrolled asthma.
KALOS and LOGOS were randomised, double-blind trials that enrolled a total of 4,434 patients with asthma to investigate Breztri as a potential treatment.
Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, Professor Alberto Papi said: “Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities.
"The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of Breztri to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.”
Breztri did not show any unexpected safety or tolerability concerns in either trial.
Full data from the two studies will be shared with regulatory authorities and presented at an upcoming medical meeting.
Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease. It received approval from the US Food and Drug Administration (FDA) on 24 July 2020 based on positive data from the Phase III ETHOS trial (NCT02465567), which showed a significant reduction in exacerbations compared with dual-combination therapies.
GlobalData forecasts that sales of Breztri will reach $2.32bn in 2030, with estimates indicating the drug will reach blockbuster status in 2025. GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in asthma, GSK is hoping for approval of its depemokimab as an add-on treatment for asthma after two Phase III trials, SWIFT-1 and SWIFT-2, met their primary endpoints. The FDA has set a Prescription Drug User Fee Act date of 16 December 2025.
"AstraZeneca’s triple-combo triumphs in two Phase III asthma trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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