AstraZeneca (NASDAQ:AZN) today announced positive high-level results from its pivotal Phase III MIRANDA trial, evaluating tozorakimab as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations compared to placebo.
The trial’s results are particularly notable for their broad applicability.
The reduction in exacerbations was observed in the primary population of former smokers as well as the overall population, which included current smokers.
Furthermore, the clinical benefit remained consistent across all blood eosinophil counts and all stages of lung function severity, suggesting tozorakimab could address a wide range of COPD presentations.
Tozorakimab is a potential first-in-class monoclonal antibody that targets interleukin-33 (IL-33).
Unlike other candidates, it uniquely inhibits the signaling of both the reduced and oxidized forms of IL-33.
This dual action allows the therapy to address two critical drivers of the disease: it reduces chronic inflammation and disrupts the cycle of mucus dysfunction that leads to disease worsening.
In the MIRANDA trial, patients received a 300mg dose of tozorakimab or a placebo via injection once every two weeks, on top of their existing inhaled standard of care.
These findings follow the positive March 2026 announcements for the OBERON and TITANIA trials, which evaluated tozorakimab at a four-week dosing interval.
Currently, nearly 400 million people live with COPD globally.
Despite existing therapies, over 50% of patients continue to experience exacerbations that can lead to hospitalization and increased mortality.
Dr. Frank Sciurba, Chief Investigator of the LUNA program, noted that these results provide a promising new option for a patient population that "urgently needs new treatment options."
Meanwhile, tozorakimab was generally well tolerated in the MIRANDA study, maintaining a favorable safety profile consistent with prior clinical evaluations.
Beyond COPD, AstraZeneca is also investigating the antibody in a Phase III trial for severe viral lower respiratory tract disease and a Phase II trial in asthma.