AstraZeneca PLC (AZN) on Monday said its pivotal Phase III MIRANDA trial of tozorakimab in patients with Chronic Obstructive Pulmonary Disease met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in exacerbations.
The study evaluated patients with COPD who continued to experience moderate-to-severe exacerbations despite receiving inhaled standard of care. In the trial, patients were treated with tozorakimab or placebo in addition to standard therapy.
AstraZeneca said the treatment significantly reduced the annualised rate of moderate-to-severe exacerbations in the primary population of former smokers, as well as in the broader population that included both former and current smokers across all blood eosinophil levels and stages of lung function severity.
The results build on previously reported positive high-level data from the Phase III OBERON and TITANIA trials, which evaluated tozorakimab at a four-week dosing interval.
The company said it plans to submit the data to regulatory authorities.
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