Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials
Tozorakimab, AstraZeneca's first-in-class anti-IL-33 monoclonal antibody, cut moderate and severe COPD exacerbations by 29-34% versus placebo in the replicate Phase III OBERON and TITANIA trials, making it the first biologic to demonstrate statistically significant efficacy in a broad COPD population. The trials randomized 2,306 patients to tozorakimab 300mg every four weeks or placebo over 52 weeks, and the benefit held across all blood eosinophil counts — a 43% exacerbation reduction at BEC ≥300, 34% at ≥150, and 23% even below 150.
Key figures
- Drug Name
- tozorakimab
- Phase Of Trial
- Phase 3
- Dosing
- 300mg once every four weeks
- Pdufa date
- Q1 2027
- Fda priority review
- Yes
- Patients randomized
- 2306
- Trial duration weeks
- 52
- Oberon rr former smokers
- 0.71 (0.57, 0.88)
- Titania rr former smokers
- 0.66 (0.55, 0.80)
- Pooled reduction bec ge 150
- 34%
- Pooled reduction bec ge 300
- 43%
- Pooled reduction bec lt 150
- 23%
- Oberon reduction former smokers
- 29%
- Titania reduction former smokers
- 34%
- Oberon reduction overall population
- 30%
- Titania reduction overall population
- 29%
AI analysis
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