AstraZeneca reported positive high-level results from the Phase III MIRANDA trial showing tozorakimab 300 mg administered every two weeks on top of standard-of-care inhaled therapy produced a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations in the trial’s primary population of former smokers and in the overall population of former and current smokers.
The double-blind, placebo-controlled trial randomized 1,454 adults with symptomatic COPD and a history of at least two moderate or one severe exacerbation in the prior 12 months; treatment continued for 52 weeks.
Tozorakimab was generally well-tolerated with a safety profile consistent with prior studies, and the data will be submitted to regulatory authorities and presented at a forthcoming medical meeting.
The MIRANDA result follows positive high-level findings from the OBERON and TITANIA pivotal trials, making this the third pivotal Phase III success for AstraZeneca’s IL-33–targeting biologic in COPD development.
Tozorakimab is being developed as a potential first-in-class monoclonal antibody targeting interleukin-33 and is also under study in other respiratory indications, according to the company.
