Experimental antibody reduces COPD flare-ups in two Phase 3 trials

An investigational antibody cut moderate-to-severe flare-ups by roughly 29% to 34% in two large Phase 3 trials involving people with chronic obstructive pulmonary disease who were still having attacks despite standard inhaled treatment. The findings suggest tozorakimab could eventually offer another option across a wider range of patients, although it has not yet been approved.

More than 1,700 current and former smokers joined the year-long OBERON and TITANIA studies. Participants received either a 300-milligram injection every four weeks or a placebo, both added to their usual inhaled therapy. Among former smokers, the annual rate of moderate or severe exacerbations fell 29% in OBERON and 34% in TITANIA. In the full study populations, including current smokers, reductions were 30% and 29%, respectively.

The treatment targets interleukin-33, a protein involved in airway inflammation and mucus production. Benefits were reported across levels of lung-function severity and blood eosinophils, a potentially important distinction because some existing biologic treatments are intended for patients with higher counts of these immune cells. Overall adverse-event and serious-adverse-event rates were comparable with placebo, though injection-site reactions were more common with tozorakimab.

AstraZeneca sponsored, designed and conducted the studies with international investigators. The results were published in the New England Journal of Medicine and presented at the European Respiratory Society Congress. The US Food and Drug Administration has accepted the treatment's application for priority review, while reviews are also underway in Europe and China.