AstraZeneca (AZ) has shared positive late-stage results for its inhaled fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) in asthma.
The phase 3 KALOS and LOGOS replicate trials have been evaluating the therapy against maintenance treatment with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines in adults and adolescents with uncontrolled cases of the respiratory disease.
Breztri Aerosphere demonstrated a statistically significant and clinically meaningful improvement in lung function compared to ICS/LABA medicines, and there were no new safety or tolerability signals identified for Breztri Aerosphere in either study.
Up to 262 million people worldwide are affected by asthma, a chronic condition characterised by inflammation and muscle tightening in the airways.
Despite the availability of standard-of-care (SOC) medicines, it is estimated that nearly half of patients receiving dual therapy remain uncontrolled and continue to experience frequent wheezing, coughing, breathlessness and chest tightness.
“The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of [Breztri Aerosphere] to evolve the SOC to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy,” said primary investigator Alberto Papi, University of Ferrara and S. Anna University Hospital.
AZ’s triple-combination therapy is already approved under the brand names Breztri Aerosphere and Trixeo Aerosphere to treat chronic obstructive pulmonary disease (COPD), a chronic respiratory disease that causes progressive lung function decline.
Full results from KALOS and LOGOS will be shared with regulatory authorities and presented at an upcoming medical meeting, AZ outlined.
Sharon Barr, executive vice president, biopharmaceuticals research and development, AZ, 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.
“This asthma data builds 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 announcement comes just days after AZ’s Calquence (acalabrutinib) regimens were recommended by the European Medicines Agency’s human medicines committee to treat chronic lymphocytic leukaemia.