AstraZeneca reported Phase III OBERON and TITANIA results showing tozorakimab reduced moderate and severe COPD exacerbations across broad patient groups.The FDA accepted tozorakimab’s Biologics License Application under Priority Review for adult COPD patients, with a target action date in the first quarter of 2027.Tozorakimab showed benefits across blood eosinophil levels, including patients with lower eosinophil counts.
AstraZeneca (NASDAQ:AZN) reported Phase III OBERON and TITANIA trial results showing tozorakimab reduced moderate and severe COPD exacerbations across broad patient populations while patients remained on standard inhaled treatment.
The trials included current and former smokers with different blood eosinophil counts and levels of lung function severity, with tozorakimab 300 mg administered once every four weeks.
In the overall population of current and former smokers, tozorakimab reduced moderate and severe exacerbations by 30% in OBERON and 29% in TITANIA compared with placebo, while pooled analyses showed reductions across blood eosinophil subgroups.
The company reported that patients with baseline blood eosinophil counts below 150 achieved a 23% reduction in exacerbations, while patients at or above 150 and 300 achieved reductions of 34% and 43%, respectively.
AstraZeneca is developing tozorakimab as a potential first-in-class monoclonal antibody targeting IL-33 signaling, with regulatory reviews underway in major markets including the United States, European Union, and China.