AstraZeneca’s tozorakimab has shown benefit in a third Phase III trial in chronic obstructive pulmonary disorder (COPD).
In the MIRANDA trial (NCT06040086), tozorakimab demonstrated a statistically significant and clinically meaningful reduction in the annualised rate of moderate-to-severe COPD exacerbations 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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
In the study, patients received tozorakimab 300mg or placebo on top of standard of care (SoC) once every two weeks. The trial enrolled patients with COPD still experiencing moderate-to-severe exacerbations while on inhaled SoC.
Dr Frank Sciurba, Professor of pulmonary and critical care medicine at the University of Pittsburgh, said: “These results add to the growing body of evidence that indicates tozorakimab delivered meaningful clinical benefits for COPD patients who urgently need new treatment options. Up to half of patients today still experience exacerbations even when taking standard-of-care inhaled therapies, putting them at risk of serious health consequences, including hospitalisation and even death.”
In March, AstraZeneca announced positive results from the pivotal Phase III OBERON (NCT05166889) and TITANIA (NCT05158387) trials studying tozorakimab at a four-week dosing interval. In both trials, tozorakimab significantly diminished the rate of moderate-to-severe annualised COPD exacerbations over placebo across all patient groups – including former and current smokers. Tozorakimab’s exacerbation-reducing efficacy also extended to those with all blood eosinophil and lung function levels.
Tozorakimab, which is also being investigated in asthma, is a potential first-in-class monoclonal antibody (mAb) targeting interleukin-33 (IL-33). The drug was generally well tolerated with a favourable safety profile consistent with previous trials.
Data from the MIRANDA study will be submitted to regulatory authorities and shared with the scientific community at an upcoming medical meeting.
The COPD market has seen significant shifts in recent years, with the introduction of biologics including Sanofi’s Dupixent (dupilumab) and GSK’s Nucala (mepolizumab). Dupixent targets IL-4 and IL-13 while Nucala targets IL-5.
While no IL-33 inhibitor is approved, Sanofi and Regeneron are also evaluating the potential of their co-developed IL-33 targeting biologic, itepekimab, but the drug demonstrated mixed Phase III results in 2025.
A KOL previously interviewed by GlobalData stated: “A drug related to IL-33 could be promising. As it acts to block the activities of IL-33 in the upper area of the route, which is far different from blood eosinophils, I believe it can be used for a wider range of patients.”
GlobalData, parent company of Clinical Trials Arena, estimates tozorakimab to reach blockbuster status in 2033, with a sales forecast of $1.16bn in the year.
This comes as GlobalData estimates that the COPD market will grow from $11.6bn in 2023 to $30.2bn in 2033 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan).
