Tozorakimab Reduces COPD Exacerbations Across All Patient Subgroups: Study

Tozorakimab, an investigational monoclonal antibody targeting the IL-33 pathway, significantly reduced moderate-to-severe exacerbations in COPD patients in phase 3 OBERON and TITANIA trials. The benefit was consistent regardless of blood eosinophil levels and across all stages of lung function severity, indicating broad effectiveness in managing COPD exacerbations.

Tozorakimab was generally well tolerated with a favorable safety profile.

Tozorakimab is a potential first-in-class monoclonal antibody targeting interleukin-33 (IL-33), that uniquely inhibits the signaling of the reduced and oxidized forms of IL-33, offering the potential to both reduce inflammation and disrupt the cycle of mucus dysfunction that contribute to COPD worsening. In the OBERON and TITANIA trials, tozorakimab was studied in patients with COPD still experiencing exacerbations while on inhaled standard of care.  Patients received tozorakimab 300mg or placebo on top of standard of care once every four weeks.

Nearly 400 million people are diagnosed with COPD, a heterogenous and progressive disease and the 3rd leading cause of death globally. 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.

Frank Sciurba, MD, FCCP, Professor of Pulmonary and Critical Care Medicine, University of Pittsburgh, Chief Investigator of LUNA program, 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, hospitalizations, cardiopulmonary events, and death — underscoring the importance of these results for advancing COPD science.”

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Today’s tozorakimab results deliver the first two confirmatory Phase III trials for an IL-33 biologic, which is a major scientific advancement in COPD, the world’s third leading cause of death. Tozorakimab works in a fundamentally different way from other biologics, inhibiting the signaling of the reduced and oxidized forms of IL-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction that are key disease drivers in COPD.”

The full results from the OBERON and TITANIA clinical trials will be shared with the scientific community at an upcoming medical meeting.

Additional Phase III trials of tozorakimab in COPD, PROSPERO and MIRANDA, are ongoing.  Tozorakimab is also being studied in a Phase III trial for severe viral lower respiratory tract disease and in a Phase II trial in asthma.

*eosinophil: a type of white blood cell, which at increased levels may contribute to inflammation in respiratory diseases.