BREZTRI achieved primary goals in KALOS and LOGOS Phase III asthma trials

WILMINGTON, Del.--Recent findings from the Phase III KALOS and LOGOS trials have shown promising results for AstraZeneca’s new asthma treatment, BREZTRI AEROSPHERE. This fixed-dose triple-combination therapy, which includes budesonide, glycopyrronium, and formoterol fumarate (BGF 320/28.8/9.6μg), has reached all its primary goals, displaying a significant and meaningful improvement in lung function compared to the traditional dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.

The KALOS and LOGOS trials were meticulously designed as replicate, randomized, and double-blind studies. Their aim was to explore the potential of BREZTRI as a treatment for asthma, focusing on its efficacy and safety against the established maintenance treatment of ICS/LABA. The trials targeted adults and adolescents suffering from uncontrolled asthma—a condition affecting up to 262 million people globally. Asthma, characterized by airway inflammation and bronchoconstriction, can severely restrict breathing, leaving nearly half of the patients on dual therapy with unresolved symptoms, thereby hampering their quality of life.

Professor Alberto Papi, a leading figure in respiratory medicine at the University of Ferrara, emphasized the significance of the trial outcomes. Despite advancements in asthma treatment, a large number of patients remain inadequately controlled, experiencing frequent symptoms like breathlessness and coughing, which can seriously affect daily life. Professor Papi highlighted the potential of BREZTRI to revolutionize current asthma care by providing a more effective single inhaled triple therapy for those who have not responded well to dual maintenance therapies.

Additionally, Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, expressed enthusiasm about the positive trial outcomes. She pointed out that these findings could substantially enhance the lives of millions battling asthma. The results further bolster BREZTRI’s already well-established profile in treating chronic obstructive pulmonary disease (COPD) and are expected to be presented to regulatory authorities soon to expand its availability to a broader patient base.

The results of the trials indicated no new safety or tolerability concerns for BREZTRI. Full trial results are set to be shared with regulatory bodies and at an upcoming medical conference. BREZTRI is already an approved treatment for COPD in over 80 countries, including the United States, European Union, China, and Japan.

Asthma is a chronic respiratory condition that affects a significant portion of the global population, including over 25 million individuals in the United States. When asthma is uncontrolled, it can lead to severe symptoms such as wheezing and breathlessness, which can greatly diminish lung function and quality of life despite the availability of standard treatments.

The KALOS and LOGOS trials involved approximately 4,400 participants in a rigorous study setup that allowed a thorough assessment of BREZTRI’s efficacy. These trials, along with the supporting LITHOS and VATHOS studies, confirmed the primary endpoints, providing a strong foundation for BREZTRI’s potential role in asthma care.

AstraZeneca’s dedication to respiratory and immunology research is evident in its longstanding commitment to addressing unmet needs in these areas. The company aims to offer life-changing medications that tackle the significant challenges posed by chronic respiratory and immune-mediated diseases, building on a rich history of medical innovation.

In conclusion, the successful outcomes of the KALOS and LOGOS trials mark an important step forward in asthma treatment, offering hope for improved management of the condition through AstraZeneca’s BREZTRI AEROSPHERE therapy. These findings underscore the potential for significant advancements in the care of asthma patients worldwide.