Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints
Celldex's pivotal Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab in chronic spontaneous urticaria met the primary endpoint and all key secondary endpoints at Week 12 in both dose groups, with highly statistically significant reductions in disease activity versus placebo. Complete response rates (UAS7=0) reached roughly 42-46% at 12 weeks and 45-54% at 24 weeks versus 9-18% on placebo, with benefit also demonstrated in omalizumab-refractory patients and those with severe disease or severe angioedema.
Key figures
- Drug Name
- barzolvolimab
- Phase Of Trial
- Phase 3
- Doses tested
- 150 mg every 4 weeks and 300 mg every 8 weeks
- Patients randomized
- 1939
- Total treatment weeks
- 52
- Bla submission planned
- 2027
- Primary endpoint result
- UAS7 LS mean change at Week 12: -20.2 (150 mg Q4W) and -20.5 (300 mg Q8W) vs -10.7 placebo in EMBARQ-CSU1; -20.2 and -19.7 vs -11.4 placebo in EMBARQ-CSU2; all p<.00001
- Complete response week12
- 42.4% / 42.1% (150 mg Q4W / 300 mg Q8W, CSU1) and 45.7% / 44.0% (CSU2) vs 9.3% / 12.6% placebo
- Complete response week24
- 49.0% / 45.1% (CSU1) and 54.0% / 48.4% (CSU2) vs 15.4% / 17.6% placebo
- Omalizumab refractory cr week12
- 55.3% / 44.3% (CSU1) and 41.7% / 46.4% (CSU2) vs 9.3% / 15.1% placebo
- Patients randomized embarq csu1
- 963
- Patients randomized embarq csu2
- 976
- Placebo controlled period weeks
- 24
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