AstraZeneca PLC announced on April 20, 2026, that the Phase III MIRANDA trial for tozorakimab, an investigational human monoclonal antibody, successfully met its primary endpoint. The trial demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) compared to placebo. This result represents the third positive pivotal Phase III readout for tozorakimab in COPD, following the OBERON and TITANIA trials reported in March 2026.
The MIRANDA trial was a randomized, double-blind, placebo-controlled study involving 1,454 adults with symptomatic COPD and a documented history of at least two moderate or one severe exacerbation in the preceding 12 months. Participants in the trial received either a 300mg dose of tozorakimab or a placebo, administered subcutaneously every two weeks for a period of 52 weeks. The study population included both former and current smokers across various stages of lung function severity and blood eosinophil counts.
According to the high-level results, tozorakimab achieved its primary objective in the population of former smokers and showed a consistent benefit in the overall study population, which served as a key secondary endpoint. The company reported that the treatment was generally well tolerated, with a safety profile consistent with findings from earlier clinical programs. No new safety signals were identified during the 52-week treatment period.
Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated that the data reinforces tozorakimab’s potential as a first-in-class biologic with a differentiated mechanism of action. Barr noted that the therapy inhibits the signaling of both the reduced and oxidized forms of interleukin-33 (IL-33), a cytokine that acts as an alarmin in response to lung tissue damage. This dual inhibition is designed to address both the underlying inflammation and the cycle of mucus dysfunction that drive COPD progression.
Frank Sciurba, MD, Chief Investigator of the LUNA program and Professor at the University of Pittsburgh, commented that the results provide meaningful clinical evidence for a broad patient population that remains at risk despite standard-of-care inhaled therapies. COPD is currently the third leading cause of death globally, and approximately half of all patients continue to experience exacerbations while on existing maintenance treatments.
AstraZeneca indicated that the full data set from the MIRANDA trial will be presented at an upcoming medical congress and shared with global regulatory authorities. The company has previously stated that tozorakimab is a central asset in its respiratory and immunology pipeline, with potential peak sales estimated between $3 billion and $5 billion. The drug is also being evaluated in Phase III trials for severe viral lower respiratory tract disease and Phase II trials for asthma.