HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD).

新泽西州汉普顿，2024年4月17日（环球通讯社）--Celldex Therapeutics，Inc.（纳斯达克股票代码：CLDX）今天宣布，该公司的巴唑伏利单抗2期临床研究已完成患者登记，用于治疗两种最常见的慢性诱导性荨麻疹（CIndU）-冷荨麻疹（ColdU）和症状性皮肤病（SD）。

CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—temperatures below skin temperature in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.

CIndU的特征是出现荨麻疹或风疹，这些荨麻疹或风疹的触发因素与ColdU的皮肤温度低于皮肤温度和SD的皮肤抓挠/摩擦有关。已知肥大细胞活化是ColdU和SD的关键驱动因素。Barzolvolimab是一种人源化单克隆抗体，可高度特异性地结合受体酪氨酸激酶试剂盒，并有效抑制其活性，这是肥大细胞功能和存活所必需的。

In February 2024, the Company presented positive 12 week primary endpoint results from its ongoing Phase 2 study of barzolvolimab in the most common form of chronic urticaria—chronic spontaneous urticaria (CSU)..

2024年2月，该公司对最常见的慢性荨麻疹-慢性自发性荨麻疹（CSU）进行了巴唑伏利单抗的2期研究，结果显示12周的主要终点结果为阳性。。

'We are very grateful to all the investigators and patients who supported this trial,' said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. 'While individuals with inducible urticaria go to great lengths to avoid disease triggers in their daily lives, many find it impossible to do so and are severely burdened by this disease.

Celldex Therapeutics总裁兼首席执行官安东尼·马鲁奇（AnthonyMarucci）说：“我们非常感谢所有支持这项试验的研究人员和患者。”虽然诱导型荨麻疹患者在日常生活中竭尽全力避免疾病触发，但许多人发现不可能这样做，并且受到这种疾病的严重负担。

This is compounded by the fact that there are currently no approved therapies for CIndU other than antihistamines. We believe barzolvolimab holds significant promise as a much needed potential treatment for patients with CIndU and look forward to presenting topline data from this study in the second half of the year.'.

除抗组胺药外，目前还没有批准的CIndU疗法，这一事实使情况更加复杂。我们认为，巴唑伏利单抗作为CIndU患者急需的潜在治疗方法具有重大前景，并期待在今年下半年提供这项研究的主要数据。”。

The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 196 patients in 2 cohorts (differentiated by CIndU subtype) including 97 patients with ColdU and 99 patients with SD were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase.

这项随机，双盲，安慰剂对照，平行组2期研究正在评估多剂量巴唑伏利单抗方案对CIndU患者的疗效和安全性，这些患者尽管接受了抗组胺治疗仍有症状，以确定最佳给药策略。2个队列中的196名患者（按CIndU亚型区分），包括97名ColdU患者和99名SD患者，以1:1:1的比例随机分配，接受皮下注射巴唑伐单抗，每4周150 mg，每8周300 mg或安慰剂在20周的治疗阶段。

Patients then enter a follow-up phase for an additional 24 weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at Week 12 (using TempTest® for ColdU and FricTest® for SD). Secondary endpoints include safety and other assessments of clinical activity including CTT (critical temperature threshold), CFT (critical friction threshold) and WI-NRS (worst itch numeric rating scale)..

然后患者进入随访阶段，持续24周。该研究的主要终点是在第12周进行阴性激发试验的患者百分比（使用Tritest®进行ColdU，使用FricTest®进行SD）。次要终点包括安全性和其他临床活动评估，包括CTT（临界温度阈值），CFT（临界摩擦阈值）和WI-NRS（最差瘙痒数字评定量表）。。

About Chronic Inducible Urticaria (CIndU)

关于慢性诱导性荨麻疹（CIndU）

CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals and angioedema when skin is exposed to temperatures below skin temperature. SD symptoms include the development of wheals and a flare reaction in response to stroking, scratching or rubbing of the skin.

CIndU的特征是荨麻疹或风疹的发生与它们有关。当皮肤暴露在低于皮肤温度的温度下时，感冒症状包括瘙痒，灼热的风团和血管性水肿。SD症状包括风团的发展和对皮肤的抚摸，抓挠或摩擦产生的耀斑反应。

Approximately 0.5% of the total population suffers from chronic inducible urticarias. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers..

大约0.5%的总人口患有慢性诱发性荨麻疹。除抗组胺药外，目前尚无批准的慢性诱导性荨麻疹治疗方法，患者试图通过避免触发来控制与疾病相关的症状。。

About Barzolvolimab

关于Barzolvolimab

Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Barzolvolimab是一种人源化单克隆抗体，可以高特异性结合受体酪氨酸激酶试剂盒并有效抑制其活性。KIT在多种细胞中表达，包括肥大细胞，其介导炎症反应，例如超敏反应和过敏反应。KIT信号传导控制肥大细胞的分化，组织募集，存活和活性。

In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), prurigo nodularis (PN) and eosinophilic esophagitis (EOE) with additional indications planned for the future..

在某些炎症性疾病中，例如慢性荨麻疹，肥大细胞活化在疾病的发作和进展中起着核心作用。Barzolvolimab目前正在慢性自发性荨麻疹（CSU），慢性诱导性荨麻疹（CIndU），结节性痒疹（PN）和嗜酸性食管炎（EOE）中进行研究，并计划在未来进行其他适应症研究。。

About Celldex Therapeutics, Inc.

关于Celldex Therapeutics，Inc。

Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases.

Celldex是一家临床阶段生物技术公司，在肥大细胞生物学和患者转化疗法开发的交叉点上领导科学。我们的管道包括基于抗体的疗法，这些疗法能够参与人体免疫系统和/或直接影响关键途径，以改善患有严重炎症，过敏，自身免疫和其他破坏性疾病的患者的生活。