WILMINGTON, Del. — AstraZeneca said its experimental biologic tozorakimab met the primary endpoint in a pivotal Phase III trial, demonstrating a meaningful reduction in flare-ups among patients with chronic obstructive pulmonary disease.
Results from the MIRANDA trial showed that the drug significantly lowered the annual rate of moderate-to-severe COPD exacerbations in both former smokers and the broader study population, which included current smokers and patients across all levels of disease severity and blood eosinophil counts.
In the trial, patients received either 300 mg of tozorakimab or a placebo every two weeks in addition to standard inhaled therapies. Participants had continued to experience exacerbations despite existing treatments.
The findings build on earlier positive results from two other Phase III studies, OBERON and TITANIA, which evaluated the drug using a four-week dosing schedule.
“These results add to the growing body of evidence that indicates tozorakimab delivered meaningful clinical benefits for COPD patients who urgently need new treatment options. Up to half of patients today still experience exacerbations even when taking standard-of-care inhaled therapies, putting them at risk of serious health consequences including hospitalization and even death,” said Frank Sciurba, MD, FCCP, Professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh and Chief Investigator of the LUNA program.
“These data further demonstrate tozorakimab’s exciting potential as a first-in-class biologic with a truly differentiated mechanism of action that inhibits the signaling of the reduced and oxidized forms of IL-33 to address underlying drivers of COPD. We look forward to sharing the data with regulators and the scientific community as soon as possible,” said Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca.
The company said tozorakimab was generally well tolerated and showed a safety profile consistent with previous trials. Full data from the study will be presented at a future medical meeting and submitted to regulators.
COPD affects nearly 400 million people worldwide and is the third leading cause of death globally. Despite standard inhaled treatments, more than half of patients continue to experience exacerbations, which can lead to hospitalization, worsening lung function, and increased risk of death.
Tozorakimab is a monoclonal antibody that targets interleukin-33, a key driver of inflammation in COPD. By blocking both the reduced and oxidized forms of IL-33, the drug is designed to reduce inflammation and interrupt processes that contribute to disease progression.
The therapy is also being studied in additional clinical trials, including a Phase III study in severe viral lower respiratory tract disease and a Phase II trial in asthma.
