Triple BGF Therapy Improved Lung Function in Patients With Uncontrolled Asthma

Triple combination therapy budesonide/glycopyrronium/formoterol fumarate (BGF) 320/28.8/9.6μg significantly improved lung function in patients with uncontrolled asthma, meeting all primary end points in the Phase III KALOS and LOGOS trials.¹

“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,” primary investigator Alberto Papi, MD, PhD, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, said in a statement.¹

The BGF triple therapy is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in over 80 countries including United States, European Union, China and Japan branded under the name Breztri Aerosphere by AstraZeneca. The KALOS and LOGOS trials that evaluated BGF were replicate, randomized, double-blind trials that evaluated the efficacy and safety of BGF versus maintenance treatment with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) in adults and adolescents with uncontrolled asthma.

The investigators did not identify any new safety or tolerability in either KALOS or LOGOS. AstraZeneca announced that full results from the 2 trials will be shared with regulatory authorities and presented at an upcoming medical meeting.

“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,” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added.¹

Other research on therapy for uncontrolled asthma focused on rademikibart was recently published in American Journal of Respiratory and Critical Care Medicine (AJRCCM). The findings demonstrated that prebronchodilator FEV1 at Week 12 improved in the rademikibart 150 mg group (least squares mean [LSM] change, +140 mL above placebo [95% CI, 44-236]; P = .005) and 300 mg group (LSM, +189 mL above placebo [95% CI, 92-286]; P <.001) compared to placebo. These improvements occurred rapidly during Week 1 and were sustained through Week 24. Notably, participants with high baseline blood eosinophils (≥300 eosinophils/mL; n = 40) had the greatest improvements, with a +420 mL increase above placebo (95% CI, 239-600) in the 300 mg group. This group had a week 1 FEV1 improvement of +312 mL. All patients with at least 150 eosinophils/µL at baseline receiving rademikibart 150 or 300 mL had significant increases in FEV1.²

Furthermore, participants receiving rademikibart had 24 acute exacerbations in 214 patients compared with 26 events in 108 patients receiving placebo. Through Week 24, 7.5% of participants in the 150 mg group and 9.3% in the 300 mg group had at least 1 exacerbation, compared with 16.7% of the placebo group.²

“It is notable that rademikibart, particularly in patients with true eosinophilic driven asthma, was associated with numerically larger placebo-adjusted improvements in FEV1 than those previously reported for other biologics,” Michael E. Wechsler, MD, MMSc, Professor of Medicine and Director, NJH Cohen Family Asthma Institute at National Jewish Health in Denver, Colorado, said in a statement.³

REFERENCES

1. BREZTRI met primary endpoints in KALOS and LOGOS Phase III trials in asthma. News release. News release. AstraZeneca. May 2, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/Breztri-met-primary-endpoints-in-kalos-and-logos-phase-III-trials-in-asthma.html#!

2. Kerwin E, Yang T, Su N, et al. Rademikibart Treatment for Moderate-to-Severe, Uncontrolled Asthma: A Phase 2B Randomized Trial. Am. J. Respir. Crit. Care Med. 2025; 0(ja). doi: 10.1164/rccm.202409-1708OC

3. Connect Biopharma Announces Publication of Positive Data from Global Phase 2 Trial of Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma. News release. Connect Biopharma. March 31, 2025. https://www.globenewswire.com/news-release/2025/03/31/3052769/0/en/Connect-Biopharma-Announces-Publication-of-Positive-Data-from-Global-Phase-2-Trial-of-Rademikibart-in-Patients-with-Moderate-to-Severe-Uncontrolled-Asthma.html