AstraZeneca has announced positive high-level results from the Phase III MIRANDA trial.
Tozorakimab, a potential first-in-class treatment, significantly reduced the annual rate of moderate-to-severe Chronic Obstructive Pulmonary Disease (COP) exacerbations in former smokers and in the overall population, which included current smokers and patients with varying blood eosinophil counts and lung function stages.
Why this matters
COPD impacts nearly 400 million people worldwide and is the third leading cause of death.
More than 50% of patients experience exacerbations while on inhaled standard care, increasing their risk of cardiopulmonary events and mortality.
Tozorakimab is a potential first-in-class monoclonal antibody targeting interleukin-33 (IL-33). It inhibits the signalling of both forms of IL-33, potentially reducing inflammation and mucus dysfunction in COPD.
In the trial, patients received either 300 mg of tozorakimab or a placebo, in addition to their standard care, every two weeks.
This study targeted patients with COPD who had moderate-to-severe exacerbations despite standard treatment.
These findings follow the positive results announced in March from the Phase III OBERON and TITANIA trials, which studied tozorakimab at a four-week dosing interval.
Dr Frank Sciurba, FCCP, Professor of Pulmonary and Critical Care Medicine, University of Pittsburgh and Chief Investigator of LUNA programme, 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.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added: "These data further demonstrate tozorakimab's exciting potential as a first-in-class biologic with a truly differentiated mechanism of action that inhibits the signalling of the reduced and oxidised forms of IL-33 to address underlying drivers of COPD."
We look forward to sharing the data with regulators and the scientific community as soon as possible.
The trial also showed that tozorakimab was well-tolerated and had a favourable safety profile, consistent with previous trials. The data will be submitted to regulatory authorities and presented at an upcoming medical meeting.
The drug is also undergoing a Phase III trial for severe viral lower respiratory tract disease and a Phase II trial for asthma.