TLDR
- AstraZeneca’s tozorakimab met the primary endpoint in the Phase III MIRANDA trial for COPD
- The drug reduced moderate-to-severe COPD exacerbations vs. placebo in both former and current smokers
- Patients received tozorakimab 300mg every two weeks on top of standard care
- This follows positive results from two other Phase III trials, OBERON and TITANIA, in March
- AstraZeneca plans to submit data to regulators and present findings at an upcoming medical meeting
AstraZeneca’s experimental COPD drug tozorakimab has cleared another Phase III hurdle, adding to what is becoming a strong clinical track record for the drug.
The MIRANDA trial showed tozorakimab produced a statistically significant reduction in the annualized rate of moderate-to-severe COPD exacerbations compared to placebo. That result held up in both the primary population of former smokers and the broader group that included current smokers.
Patients in the trial received tozorakimab 300mg or placebo every two weeks on top of their existing standard care. The trial enrolled patients who were still experiencing exacerbations despite already being on inhaled treatments.
The safety profile was consistent with earlier trials, and the drug was described as generally well tolerated.
Third Positive Phase III Result
This is not the first time tozorakimab has delivered good news. In March, AstraZeneca announced positive results from two other Phase III trials — OBERON and TITANIA — which tested the drug at a four-week dosing interval.
MIRANDA used a two-week dosing schedule, giving AstraZeneca data across different dosing frequencies.
The drug is a potential first-in-class monoclonal antibody that targets interleukin-33, a protein involved in inflammation. That mechanism of action is what makes it stand out from existing inhaled COPD treatments.
Frank Sciurba, a professor at the University of Pittsburgh and chief investigator of the LUNA program, said the results “add to the growing body of evidence that indicates tozorakimab delivered meaningful clinical benefits for COPD patients who urgently need new treatment options.”
COPD affects close to 400 million people globally and is the third leading cause of death worldwide. More than half of patients continue to experience exacerbations even while on standard inhaled therapies — a gap tozorakimab appears designed to fill.
What Comes Next
AstraZeneca plans to submit the MIRANDA data to regulatory authorities. The company will also present the findings at an upcoming medical meeting, though no specific date or conference has been named yet.
Beyond COPD, tozorakimab is being studied in Phase III trials for severe viral lower respiratory tract disease and in Phase II trials for asthma.
The MIRANDA results covered patients across all blood eosinophil counts and all stages of lung function severity, which broadens the potential patient population the drug could serve.
AstraZeneca has not yet confirmed a regulatory submission timeline.
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