WILMINGTON, DE — AstraZeneca (NYSE: AZN) said its experimental drug tozorakimab reduced moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease in two Phase III trials, according to results from the OBERON and TITANIA studies.
The company said the trials met primary endpoints, showing a reduction in annualized exacerbation rates compared with placebo in former smokers and in the overall study population, which included both current and former smokers.
Tozorakimab was administered alongside standard inhaled therapy every four weeks and was generally well tolerated with a favorable safety profile, the company said.
The drug targets interleukin-33, a protein involved in inflammation, and is designed to reduce airway inflammation and mucus dysfunction associated with COPD.
The OBERON and TITANIA trials enrolled a combined 2,306 patients with symptomatic COPD who had a history of frequent exacerbations despite standard treatment.
Frank Sciurba, a professor of pulmonary and critical care medicine at the University of Pittsburgh and chief investigator of the program, said the results show potential benefit across a broad patient population.
“These trial results suggest that targeting the IL-33 pathway with tozorakimab delivers meaningful clinical benefit … independent of smoking status and eosinophilic levels,” Sciurba said.
Sharon Barr, executive vice president of BioPharmaceuticals research and development at AstraZeneca, said the studies represent confirmatory Phase III data for an IL-33-targeting therapy.
“Today’s tozorakimab results deliver the first two confirmatory Phase III trials for an IL-33 biologic,” Barr said.
COPD affects nearly 400 million people worldwide and is the third leading cause of death globally, according to the company.
Additional Phase III trials of tozorakimab, including PROSPERO and MIRANDA, are ongoing, with results expected in the first half of 2026.
The company said full data from the OBERON and TITANIA trials will be presented at an upcoming medical meeting.
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