AstraZeneca releases successful trial results for tozorakimab in COPD treatment
AstraZeneca has released the full results of two successful late-stage clinical trials of the biologic drug tozorakimab for the treatment of chronic obstructive pulmonary disease (COPD). As CNBC Top News reports, the drug, administered once every four weeks, reduced the frequency of exacerbations in a broad group of patients.
Study results
In the key group of former smokers, tozorakimab reduced the rate of moderate COPD exacerbations by 29% and severe exacerbations by 34% compared with placebo alongside standard inhaled therapy. In the broader group of current and former smokers, the reduction was 30% for moderate and 29% for severe exacerbations.
The studies involved current and former smokers with all levels of blood eosinophils and varying degrees of impaired lung function. In a separate analysis, the drug reduced the number of moderate and severe exacerbations by 23% among patients with eosinophil levels below 150, by 34% among patients with levels of 150 or higher, and by 43% in the group with levels of 300 or higher.
Regulatory review and sales
Tozorakimab is under priority review by the U.S. Food and Drug Administration. Approval of the drug in the United States is expected in the first quarter of 2027. According to Ruud Dobber, president of AstraZeneca's biopharmaceuticals business, the drug is also under regulatory review in the EU and China.
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The company raised its forecast for tozorakimab's peak annual sales to more than $5 billion. AstraZeneca believes the drug could be available to a broader group of patients than the existing COPD biologics Dupixent and Nucala, which are prescribed to patients with high eosinophil levels.
Mechanism of action
Tozorakimab blocks the IL-33 protein, which stimulates inflammation and mucus production — factors associated with the development of COPD. AstraZeneca says its antibody suppresses two different IL-33 pathways, while previous approaches were mainly focused on blocking one pathway of inflammation.
Meylan Han, head of the Division of Pulmonary and Critical Care Medicine at University of Michigan Health and one of the researchers, noted that the place of tozorakimab among existing biologics for patients with high eosinophil levels has yet to be determined. No direct comparative trials of the new drug against other COPD biologics have been conducted.
