Efficacy of Barzolvolimab - At Week 52, 71% of patients receiving 150 mg Q4W of barzolvolimab achieved a complete response in CSU, demonstrating the highest rate of complete response observed in a well-controlled study[16] - At Week 12, 51% of patients on the 150 mg Q4W dosage achieved complete response, compared to only 6% in the placebo group[16] - 7 months post-treatment (Week 76), 41% of patients in the 150 mg Q4W group sustained a complete response[16] - At Week 76, 47%-56% of barzolvolimab patients had well controlled disease[50] Safety and Tolerability - Barzolvolimab demonstrates a well-tolerated, long-term safety profile in Phase 2 trials[25] - Most adverse events are mild (Grade 1), KIT-mediated effects and reversible during follow-up period[27] - Localized hair color changes/lightening occurred in 48 patients through 52 weeks of treatment, with >90% already resolved at study closure[36] - Small areas of hypo-pigmentation occurred in 30 patients through 52 weeks of treatment, with >70% already resolved at study closure[36] Impact on Quality of Life - 92% of patients report moderate to high impact from CSU on their daily life[11] - At Week 76, 40%-48% of patients on barzolvolimab reported CSU had no impact (0-1) on their quality of life[53] - At Week 52, 82% of patients on the 150 mg Q4W dosage reported CSU had no impact (0-1) on their quality of life[57]
Celldex Therapeutics (CLDX) Earnings Call Presentation