AstraZeneca has reported positive high-level results from the Phase III OBERON and TITANIA trials in patients with chronic obstructive pulmonary disease (COPD).
The trials showed that tozorakimab reduced the annualised rate of moderate-to-severe COPD exacerbations compared to a placebo, particularly in former smokers and across patients with varying blood eosinophil counts and lung function stages.
It was generally well-tolerated and had a favourable safety profile.
Tozorakimab is a first-in-class monoclonal antibody targeting interleukin-33 (IL-33). It inhibits both the reduced and oxidised forms of IL-33, potentially reducing inflammation and breaking the cycle of mucus dysfunction in chronic obstructive pulmonary disease (COPD).
In the OBERON and TITANIA trials, patients with COPD experiencing exacerbations while on standard care received either 300 mg of tozorakimab or a placebo every four weeks, alongside their usual treatment.
Why this matters
Nearly 400 million people are diagnosed with COPD, a heterogeneous and progressive disease and the third 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.
Dr Frank Sciurba, 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, cardiopulmonary events and death—underscoring the importance of these results for advancing COPD science.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added: "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 signalling of the reduced and oxidised forms of IL-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction that are key disease drivers in COPD.
The company said that comprehensive results from the OBERON and TITANIA clinical trials will be presented to the scientific community at an upcoming medical conference.
Additionally, Phase III trials of tozorakimab for Chronic Obstructive Pulmonary Disease (COPD), known as PROSPERO and MIRANDA, are currently in progress. Tozorakimab is also being investigated in a Phase III trial for severe viral lower respiratory tract diseases and in a Phase II trial for asthma.