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Tozorakimab met OBERON/TITANIA primary endpoints
AstraZeneca PLC announced positive high-level results from its Phase III OBERON and TITANIA trials for tozorakimab in patients with COPD, demonstrating statistically significant and clinically meaningful reductions in exacerbations compared to placebo across various patient subgroups. Tozorakimab, a first-in-class IL-33 targeting biologic, was generally well tolerated and showed a favourable safety profile. These results represent a significant advancement in COPD treatment, addressing a major unmet need for the nearly 400 million people globally diagnosed with this progressive disease. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\nThis announcement contains inside information\n \n27 March 2026\n \nTozorakimab met primary endpoint in both OBERON and TITANIA Phase III trials in patients with COPD \n \nFirst-ever IL-33-targeting biologic to demonstrate statistically significant and highly clinically meaningful reductions in COPD exacerbations in two replicate Phase III clinical trials\n \nPositive high-level results from the Phase III OBERON and TITANIA trials in patients with chronic obstructive pulmonary disease (COPD) showed that tozorakimab reduced the annualised rate of moderate-to-severe COPD exacerbations compared with placebo, in the primary population of former smokers, and in the overall population, which included former and current smokers, and patients across all blood eosinophil* counts and all stages of lung function severity. Tozorakimab was generally well tolerated with a favourable safety profile.\n \nTozorakimab is a potential first-in-class monoclonal antibody targeting interleukin-33 (IL-33), that uniquely inhibits the signalling of the reduced and oxidised forms of IL-33, offering the potential to both reduce inflammation and disrupt the cycle of mucus dysfunction that contribute to COPD worsening.1-4 In the OBERON and TITANIA trials, tozorakimab was studied in patients with COPD still experiencing exacerbations while on inhaled standard of care.5,6 Patients received tozorakimab 300mg or placebo on top of standard of care once every four weeks.\n\nNearly 400 million people are diagnosed with COPD, a heterogenous and progressive disease and the 3rd leading cause of death globally.7,8 Even when on inhaled standard of care, more than 50% of patients experience exacerbations, putting them at an increased risk of cardiopulmonary events and mortality.9-12\n \nFrank Sciurba, MD, FCCP, Professor of Pulmonary and Critical Care Medicine, University of Pittsburgh, Chief Investigator of LUNA programme, said: \"These trial results suggest that targeting the IL-33 pathway with tozorakimab delivers meaningful clinical benefit in a trial representing a broad COPD population, independent of smoking status and eosinophilic levels. COPD has long been a difficult-to-treat disease with inherent heterogeneity and significant unmet need, with up to half of patients worldwide at risk of exacerbations, hospitalisations, car...