AstraZeneca’s tozorakimab cuts COPD exacerbations by up to 34% in phase 3 trials
pharmafile | October 4, 2026 | News story | | Asthma & COPD, COPD, asthma, clinical trials, monoclonal antibodies
AstraZeneca’s tozorakimab reduced moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) in two phase 3 trials, cutting exacerbation rates by 29% and 34% among former smokers.
Its OBERON and TITANIA trials were replicate, double-blind, placebo-controlled studies involving a total of 2,306 patients with symptomatic COPD and a history of at least two moderate or one severe exacerbation in the previous 12 months.
Patients received either 300mg of tozorakimab or placebo once every four weeks for 52 weeks alongside their existing inhaled maintenance therapy. The primary endpoint was the annualised rate of moderate-to-severe exacerbations in former smokers.
Tozorakimab reduced exacerbations by 29% in former smokers in OBERON and by 34% in TITANIA, compared with placebo. In the overall populations of current and former smokers, the reductions were 30% and 29%, respectively.
A pooled analysis of the two trials indicated that the effect was greater among patients with higher blood eosinophil counts. Exacerbations were reduced by 43% among patients with counts of at least 300 cells/µL, compared with 23% among those with counts below 150 cells/µL. The analysis of patients with counts of at least 150 cells/µL was post-hoc.
Tozorakimab is a monoclonal antibody targeting interleukin-33 (IL-33), an inflammatory signalling protein. AstraZeneca says the treatment is designed to inhibit IL-33 signalling and address inflammation and mucus dysfunction.
The trials included both current and former smokers and patients across all blood eosinophil counts and stages of lung function severity. AstraZeneca announced positive high-level results from OBERON and TITANIA in March.
Tozorakimab is also being investigated in a phase 3 trial for severe viral lower respiratory tract disease and a phase 2 trial in asthma. It has received US Food and Drug Administration Fast Track designation for COPD and severe viral lower respiratory tract disease. Pic: Andres Siimon
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