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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...

塞德斯医疗在EADV 2024年会上介绍巴祖珀利膜单抗2期研究的52周结果;71%的患者在第52周达到完全缓解;在第1周早期即出现UAS7快速、显著且持久改善...
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

塞德斯医疗在EADV 2024年度上报了巴佐格利单抗(Barzolvolimab)2期研究52周结果,71%的患者在第52周达到完全缓解;从第1周开始UAS7表现出迅速、深刻和持久的改善,在52周内有所加深

- 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周实现完全缓解 -
- 从第1周开始,UAS7表现出迅速、深刻和持久的改善,在52周内有所加深 -
- 在omalizumab经验丰富/难治/未经治疗的病例中表现出强劲的改善 -
- 52周内耐受性良好 -
- 正在进行全球第3期CSU试验的招募工作 -
- 公司将于今天美国东部时间12:00 pm/中欧时间6:00 pm举办网络研讨会 -

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,新泽西州汉普顿(HAMPTON)(全球新闻社)-- 塞德斯医疗(Celldex Therapeutics,NASDAQ:CLDX)今日宣布了新数据,证实巴佐格利单抗(Barzolvolimab)在慢性自发性荨麻疹(CSU)的52周治疗期间展现了持续且加深的疗效,以及良好的耐受性特征。CSU是由肥大细胞活化所引发的免疫相关性疾病。巴佐格利单抗通过高度特异性地结合受体酪氨酸激酶KIt并有效抑制其活性来特异性地靶向肥大细胞,这对于肥大细胞的功能和存活是必要的。今日,柏林夏瑞特-柏林大学医学院皮肤病学和过敏学教授马丁·梅茨博士在EADV 2024年大会上发表了这些数据,这是一项关于巴佐格利单抗在中度至重度CSU难治性抗组胺药物(包括生物制剂耐药性疾病)患者中的2期研究。该研究已经达到了其主要终点--在12周内相对于安慰剂的UAS7显著改善--所有测试的剂量组都取得了成功。

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