Tozorakimab, a potential first-in-class monoclonal antibody targeting interleukin-33 (IL-33), has met the primary endpoint in two phase 3 trials involving patients with COPD.
According to a news release from AstraZeneca, the manufacturer of tozorakimab, the OBERON and TITANIA phase 3 trials studied the treatment in patients with COPD who still experienced exacerbations while on inhaled standard care. Patients were given tozorakimab 300mg or placebo once every four weeks on top of the standard care.
The results of the study — which will be released at a later date — showed that tozorakimab reduced the annualized rate of moderate-to-severe COPD exacerbations compared with placebo in the primary population of former smokers and in the overall population, which included former and current smokers. It also reduced the annualized rate of moderate-to-severe COPD exacerbations across all blood eosinophil counts and all stages of lung function severity.
“These trial results suggest that targeting the IL-33 pathway with tozorakimab delivers meaningful clinical benefit in a trial representing a broad COPD population, independent of smoking status and eosinophilic levels,” 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.
“[These] tozorakimab results deliver the first two confirmatory phase 3 trials for an IL-33 biologic, which is a major scientific advancement in COPD,” said Sharon Barr, executive vice president of biopharmaceuticals R&D for AstraZeneca. “Tozorakimab works in a fundamentally different way from other biologics, inhibiting the signaling of the reduced and oxidized forms of IL-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction that are key disease drivers in COPD.”
Additional phase 3 trials of tozorakimab in COPD — PROSPERO and MIRANDA — are ongoing. The treatment is also being studied in a phase 3 trial for severe viral lower respiratory tract disease and a phase 2 trial for asthma.
