Tozorakimab, a potential first-in-class monoclonal antibody targeting interleukin-33 (IL-33), has met a primary endpoint in the phase 3 MIRANDA trial, marking its third success since the beginning of 2026.
This follows the drug’s positive results in the OBERON and TITANIA phase 3 trials in March.
According to a press release from manufacturer AstraZeneca, tozorakimab demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations in both the primary population of former smokers and the overall population including former and current smokers. The drug was effective across all blood eosinophil counts and all stages of lung function severity.
Patients received 300 mg of tozorakimab or a placebo in addition to standard of care once every two weeks. The trial included patients with COPD who were still experiencing moderate-to-severe exacerbations while on inhaled standard of care. The primary endpoint was the annualized rate of moderate-to-severe COPD exacerbations in former smokers with COPD. A key secondary endpoint measured the annualized rate of moderate-to-severe COPD exacerbations in the overall population of former and current smokers.
Tozorakimab inhibits the signaling of the reduced and oxidized forms of IL-33, which can potentially reduce inflammation while also disrupting the cycle of mucus dysfunction that contributes to the worsening of COPD.
“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,” said Frank Sciurba, MD, FCCP, professor of pulmonary and critical care medicine at the University of Pittsburgh and chief investigator of the LUNA program, which is overseeing the trials. “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 hospitalization and even death.”
Tozorakimab was generally well tolerated with a favorable safety profile consistent with previous trials. The company plans to submit the data from this and the previous trials to regulatory authorities and will share it with the scientific community in the near future.
