AstraZeneca (NYSE: AZN) announced that its experimental drug tozorakimab met the primary endpoint in the Phase III MIRANDA trial for patients with chronic obstructive pulmonary disease (COPD).

The trial demonstrated that tozorakimab 300mg administered every two weeks resulted in a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations compared to placebo. The reduction was observed in both the primary population of former smokers and the overall population including former and current smokers.

MIRANDA enrolled 1,454 patients with COPD who continued experiencing moderate-to-severe exacerbations despite standard inhaled therapy. Participants received either tozorakimab or placebo on top of standard care for 52 weeks.

The results follow positive outcomes from two other Phase III trials, OBERON and TITANIA, announced in March, which tested tozorakimab at a four-week dosing interval.

"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," said Frank Sciurba, Professor of Pulmonary and Critical Care Medicine at University of Pittsburgh and Chief Investigator of the LUNA program.

Tozorakimab is a monoclonal antibody targeting interleukin-33 (IL-33) and is positioned as a potential first-in-class biologic treatment. The drug was generally well tolerated with a safety profile consistent with previous trials, according to the company.

The data will be submitted to regulatory authorities and presented at an upcoming medical meeting. AstraZeneca received Fast Track Designation from the FDA for tozorakimab in COPD treatment in December 2024.

COPD affects nearly 400 million people globally and is the third leading cause of death worldwide. More than 50% of patients experience exacerbations despite standard inhaled therapies.