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Celldex Therapeutics Presents 52-Week Results From Barzolvolimab Phase 2 Study In Chronic Spontaneous Urticaria At EADV 2024; 71% Of Patients Achieved Complete Response At Week 52; Rapid, Profound And Durable Improvement In UAS7 As Early As Week 1...

Celldex Therapeutics Presents 52-Week Results From Barzolvolimab Phase 2 Study In Chronic Spontaneous Urticaria At EADV 2024; 71% Of Patients Achieved Complete Response At Week 52; Rapid, Profound And Durable Improvement In UAS7 As Early As Week 1...

塞德斯醫療在EADV 2024年會上介紹巴祖珀利膜單抗2期研究的52周結果;71%的患者在第52周達到完全緩解;在第1周早期即出現UAS7快速、顯著且持久改善...
Benzinga ·  09/25 10:47

Celldex Therapeutics Presents 52-Week Results From Barzolvolimab Phase 2 Study In Chronic Spontaneous Urticaria At EADV 2024; 71% Of Patients Achieved Complete Response At Week 52; Rapid, Profound And Durable Improvement In UAS7 As Early As Week 1 With A Deepening Of Response Over 52 Weeks

塞德斯醫療在EADV 2024年度上報了巴佐格利單抗(Barzolvolimab)2期研究52周結果,71%的患者在第52周達到完全緩解;從第1周開始UAS7表現出迅速、深刻和持久的改善,在52周內有所加深

- 71% of patients (150 mg Q4W) achieved complete response at Week 52 -
- Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks -
- Robust improvement across omalizumab-experienced/refractory/naïve disease -
- Well tolerated through 52 weeks -
- Enrollment to Global Phase 3 CSU trials underway -
- Company to host webcast today at 12:00 pm ET/6:00 pm CEST -

- 71%的患者(每4周150毫克)在第52周實現完全緩解 -
- 從第1周開始,UAS7表現出迅速、深刻和持久的改善,在52周內有所加深 -
- 在omalizumab經驗豐富/難治/未經治療的病例中表現出強勁的改善 -
- 52周內耐受性良好 -
- 正在進行全球第3期CSU試驗的招募工作 -
- 公司將於今天美國東部時間12:00 pm/中歐時間6:00 pm舉辦網絡研討會 -

HAMPTON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new data demonstrating sustained and deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period for barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The data are bring presented today by Dr. Martin Metz, Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin in a late breaking oral presentation at the EADV Congress 2024. The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks—across all dose groups tested.

2024年9月25日,新澤西州漢普頓(HAMPTON)(全球新聞社)-- 塞德斯醫療(Celldex Therapeutics,NASDAQ:CLDX)今日宣佈了新數據,證實巴佐格利單抗(Barzolvolimab)在慢性自發性蕁麻疹(CSU)的52周治療期間展現了持續且加深的療效,以及良好的耐受性特徵。CSU是由肥大細胞活化所引發的免疫相關性疾病。巴佐格利單抗通過高度特異性地結合受體酪氨酸激酶KIt並有效抑制其活性來特異性地靶向肥大細胞,這對於肥大細胞的功能和存活是必要的。今日,柏林夏瑞特-柏林大學醫學院皮膚病學和過敏學教授馬丁·梅茨博士在EADV 2024年大會上發表了這些數據,這是一項關於巴佐格利單抗在中度至重度CSU難治性抗組胺藥物(包括生物製劑耐藥性疾病)患者中的2期研究。該研究已經達到了其主要終點--在12周內相對於安慰劑的UAS7顯著改善--所有測試的劑量組都取得了成功。

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