AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere has met all primary endpoints in the Phase 3 KALOS and LOGOS trials for patients with uncontrolled asthma.
The trials confirmed the efficacy of Breztri in improving lung function compared to dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), also known as BGF, combines budesonide, glycopyrronium, and formoterol fumarate.
It has been approved for chronic obstructive pulmonary disease (COPD) in over 80 countries, including China, the EU, Japan, and the US.
The single-inhaler, fixed-dose therapy is marketed as Breztri Aerosphere in China, Japan, and the US, and as Trixeo Aerosphere in the EU.
AstraZeneca biopharmaceuticals R&D executive vice president Sharon Barr said: “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.
“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.”
The KALOS and LOGOS studies are designed as randomised and double-blind clinical trials to evaluate Breztri’s potential as an asthma treatment.
Breztri, evaluated in around 4,400 patients against ICS/LABA maintenance treatments, showed significant improvements in lung function without new safety concerns.
The trials optimised the 320/28.8/9.6μg dose of Breztri, with primary efficacy endpoints including changes in forced expiratory volume in one second (FEV1) over specific periods.
In addition to KALOS and LOGOS, two qualifying trials, LITHOS and VATHOS, also achieved their primary endpoints, involving around 1,000 patients.
The studies primary investigator 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 budesonide/glycopyrronium/formoterol 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.”
