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  <title>启明星 | ​康乃德生物医药启动CBP-201治疗中重度特应性皮炎成人患者的全球二期临床试验 | Qiming Venture Partners</title>
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            <h2 class="font-medium">启明星 | ​康乃德生物医药启动CBP-201治疗中重度特应性皮炎成人患者的全球二期临床试验</h2>
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          <span class="date-display-single">21/07/2020</span>    
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          启明创投    
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          <p><strong>专注于开发治疗自身免疫性疾病和炎症性疾病领域的新型免疫调节剂的康乃德生物医药宣布，已完成CBP-201治疗中重度特应性皮炎(AD)成人受试者二期临床研究首例受试者的首次给药。</strong></p>

<p>作为一种新型的IL-4Rα抗体，CBP-201在1b期临床试验结果的数据显示出其对AD患者4周治疗比目前特应性皮炎标准疗法的临床数据具有更佳疗效的优势。</p>

<p><strong>作为负责CBP-201临床二期研究入组患者的首位研究者，美国佛罗里达州好莱坞市Encore研究中心顾问、皮肤科执业医师BrianFeinstein表示：</strong>“与特应性皮炎相关的湿疹样皮肤病变、瘙痒、局部疼痛和睡眠障碍会严重影响患者的躯体功能、社交能力和其他日常活动能力。所有的特应性皮炎患者中，中重度特应性皮炎约占30%，其中对皮质类固醇无应答的患者，目前可供选择的治疗手段非常有限。CBP-201的1b期临床疗效是非常振奋人心的，今天启动的2期临床研究将进一步探索CBP-201在改善中重度特应性皮炎治疗的优势潜力。”</p>

<p><strong>2020年1月，康乃德生物医药发表了CBP-201临床1b期的研究结果。</strong>从基线至第29天的湿疹面积及严重程度评分(EASI)指标的变化显示，CBP-201可快速改善中重度特应性皮炎患者的皮损。在第29天，300mg和150mg给药组分别有42.9%和50.0%的患者达到了皮损“清除/基本清除”，即研究者整体评估(IGA)为0或1分(该指标是FDA批准治疗AD药物上市所需的主要疗效终点)，而安慰剂组中仅为12.5%。此外，研究表明在CBP-201给药后仅1周受累皮肤病变即得到了改善。同时，瘙痒强度及瘙痒频率也在给药后得到了迅速改善。安全性方面，CBP-201各剂量组均显示了良好的安全性与耐受性。</p>

<p><strong>康乃德生物医药联合创始人及首席执行官郑伟博士表示：</strong>“我们相信，CBP-201在治疗中重度特应性皮炎中具有同类最佳的潜力，对于在 2期临床研究中进一步验证CBP-201更卓越的疗效优势我们持乐观态度”。IL-4Rα是已被FDA批准用于治疗特应性皮炎药物Dupilumab的作用靶点。但是，大多数AD患者在Dupilumab治疗16周后其皮损无法达到“清除”或“基本清除”的状态，未满足的医疗需求仍然非常显著。我们临床1b期试验的数据表明，<strong>与Dupilumab相应的临床数据相比，CBP-201具有起效更快、疗效更佳及给药频率更低等潜能，有望为特应性皮炎患者提供更好的治疗效果。”&nbsp; &nbsp;</strong></p>

<section>这项随机、双盲、安慰剂对照的临床二期研究将在美国、澳大利亚、新西兰、中国、欧洲和英国等全球60多个临床中心招募约220名中重度特应性皮炎的成人受试者(年龄18至75岁)，受试者将随机(1:1:1:1)接受三种CBP-201给药方案中的一种或安慰剂皮下注射给药，研究包括16周的治疗期及(最后一次)给药后8周的随访期。<strong>该研究的主要目的是评估不同给药方案在该患者群体中的有效性，次要目的是评估其安全性和耐受性，并描述各种给药方案下的稳态药代动力学(PK)特征。研究结果预计将于2021年下半年公布。</strong></section>

<p><strong>康乃德生物医药是一家具有临床阶段产品的生物医药公司。</strong>公司独特的免疫调节技术平台是基于T细胞生物学功能的高通量筛选平台，与传统的研发方法相比，能够更快速高效地鉴定出作用于特定疾病致病通路中的靶向分子。</p>

<section>
<p><strong>除CBP-201外，康乃德生物医药的另一个领先的候选药物CBP-307是新一代口服型S1P1和S1P5调节剂，用于治疗包括炎症性肠病、银屑病和多发性硬化在内的多种自身免疫性疾病。</strong>在两项已完成的临床1期随机、双盲、安慰剂对照研究中，CBP-307表现出良好的安全性、高效的T细胞调节活性，以及理想的药代动力学和药效学特征，显示出同类最佳的潜力。CBP-307目前正在进行两项二期临床研究，以评估其在中重度溃疡性结肠炎和中重度克罗恩病患者中的疗效和安全性。</p>

<p>此外，该公司在同步推进三个临床前项目，包括两个小分子候选药物(CBP-174和CBP-312)和一个靶向IL-33抗体(CBP-233)，用于治疗多种严重的炎症性疾病。</p>
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