Connect Biopharma Holdings Ltd. announced that China's key clinical trials of CBP-201 in the treatment of moderate and severe atopic dermatitis have successfully reached the primary end point and all key secondary end points.

PR Newswire · Oct 4, 2022 13:35

本次分析基于255例中国中重度AD患者，第16周的研究结果成功达到了主要终点和所有关键次要终点，且具有高度显著性差异
与靶向IL-4Rα的同类药物一致，CBP-201的安全性和耐受性良好
研究结果支持进一步与CDE进行在中国递交NDA的讨论
公司将于今天太平洋时间上午5:30/美国东部时间上午8:30通过电话会议的形式交流相关结果

江苏太仓2022年10月5日 /美通社/ -- 康乃德生物医药有限公司（纳斯达克股票代码：CNTB，以下简称"康乃德"或"公司")，是一家拥有临床阶段产品、全球化布局的生物医药公司，通过自主研发的T细胞功能调节平台开发创新疗法，从而改善慢性炎症性疾病患者的生活品质。公司今日公布了其主要候选药物CBP-201在中国中重度特应性皮炎（AD）患者中开展的关键临床试验主要分析的顶线结果。该项多中心、随机、双盲、平行组、安慰剂对照试验旨在评估CBP-201的有效性和安全性，并通过维持治疗期评估延长CBP-201给药间隔时间的可能性。

在第16周时，CBP-201治疗组（300mg，每两周给药一次）达到主要终点（IGA评分为0或1分且较基线降低≥2分, 相当于皮损"清除"或"基本清除"）的受试者比例明显高于安慰剂组（30.3% vs 7.5%; p<0.001）。该研究也成功达到了所有关键次要终点，其中包括：CBP-201治疗组中分别有83.1%，62.9%和35.8%的受试者达到了EASI-50,EASI-75和EASI-90（ESAI评分较基线降低大于等于50%,75%和90%），安慰剂组的应答率分别为41.1%，23.4%和6.3%（所有p值均 < 0.001）；CBP-201治疗组中35%的受试者PP-NRS（峰值瘙痒数字评估量表）评分较基线下降≥4分，安慰剂组的相应受试者比例为9.6%（p<0.001）；并且相比安慰剂组，CBP-201治疗组PP-NRS评分较基线的百分比变化在首剂给药后第一周就呈现出了具有显著统计学意义的降低，这些均提示瘙痒得到了显著改善。

CBP-201的总体耐受性良好，安全性结果与安慰剂相当：在16周治疗期间，CBP-201治疗组TEAE(治疗期不良事件)的发生率为73.5%，安慰剂组为72.9%；CBP-201治疗组SAE(严重不良事件)的发生率为0.6%，安慰剂组为3.5%。大多数TEAE的严重程度为轻度至中度，且并未导致研究药物停药。研究中最常见的治疗期AESI（特别关注的不良事件）为：持续时间超过24h的注射部位反应 (CBP-201治疗组和安慰剂组的发生率分别为6.5%和0.0%，所有这些注射部位反应的严重程度均为轻度)和结膜炎（CBP-201治疗组和安慰剂组的发生率分别为4.7%和3.5%）。

"我们每天都在治疗患有这种难缠疾病的患者，该疾病的症状包括皮损部位持续强烈的瘙痒、疼痛、红斑、干燥、渗出、结痂和皮肤开裂。" 本试验的牵头研究者，北京大学人民医院皮肤科主任张建中教授说道,"这些来自迄今为止中国规模最大的特应性皮炎临床研究的主要疗效结果令人印象深刻，这一安全有效的治疗方法也为患者带来了新的希望。我们十分期待不久的将来能有新的治疗AD的选择，以便满足更多AD患者的需求。"

"很高兴看到来自中国关键临床试验的重要积极结果为CBP-201提供了可用于支持NDA的疗效和安全性数据。" 康乃德联合创始人兼首席执行官郑伟博士说道，"正在进行的第二阶段研究将为我们提供评估CBP-201长期疗效的重要机会，包括继续当前的每两周一次给药方案(Q2W)以及更加方便的每四周一次给药方案(Q4W)，在我们的全球2b期试验中，Q4W同样也显示出了在皮肤清除率、疾病严重程度和瘙痒等方面的显著改善。"

公司计划在接下来几个月与CDE(国家药品监督管理局药品审评中心) 进行沟通，以讨论完成该试验后进行NDA递交的可能性。

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关于本临床试验

CBP-201治疗中重度特应性皮炎的中国关键临床试验(NCT05017480)是一项正在进行中的多中心、随机、双盲、平行组、安慰剂对照试验，其主要研究目的是评估药物的有效性和安全性，研究将分为两个阶段。入组的受试者以2:1的比例随机接受CBP-201或安慰剂治疗。在为期16周的研究第一阶段，CBP-201治疗组的受试者在第1天接受600mg的负荷剂量，之后接受300mg 每两周一次（Q2W）给药。安慰剂对照组的受试者接受匹配的安慰剂给药。在第1阶段治疗期结束后，达到EASI-50的受试者将按1比1的比例随机分组，在第二阶段维持治疗期（36周）接受CBP-201 300mg 每两周一次（Q2W）给药或CBP-201 300mg 每四周一次（Q4W）给药。在第1阶段治疗期未达到EASI-50的患者将在第2阶段治疗期接受CBP-201 300mg 每两周一次（Q2W）给药。

本次分析是根据CDE要求，基于已完成第1阶段的255名成年患者（主要分析人群）进行的。在此分析的基础上，公司还计划与CDE沟通，以确定是否需要对主要分析人群以外的其他参与试验的成人和青少年患者进行补充分析。

关于特应性皮炎和CBP-201

特应性皮炎（AD）是最常见的慢性炎症性皮肤病，其特点是皮肤屏障破坏和免疫调节异常，终生患病率高达约20%，且在全球范围内呈上升趋势。对中国AD患病率的估计显示，随着时间的推移，AD患病率也在逐渐升高。最近的纵向研究报告显示，在中国三级医院就诊的门诊患者中，经皮肤科医生诊断的AD患病率为7.8%。在美国，估计有2,610万人患有AD，其中660万患者的疾病程度为中度至重度。另外，现有的治疗方法(包括外用抗炎药物和全身性药物)对超过58%的中重度AD患者均不能有效控制其症状。

CBP-201是一个靶向IL-4Rα（白介素-4受体α亚基）的抗体药物，IL-4Rα是治疗包括AD在内的多种Th2型炎症性疾病的有效靶点。一项针对成人中重度AD患者的2b期全球多中心临床试验结果显示：CBP-201具有良好的安全性和有效性。

关于康乃德生物医药

康乃德是一家在美国和中国开展业务，拥有临床阶段产品的生物医药公司，通过自主研发的T细胞功能调节平台开发创新疗法，致力于改善炎症性免疫疾病患者的生活品质。公司利用T细胞的功能性细胞检测来筛选和发现针对有效免疫目标的有效候选产品，以建立丰富的自主研发的、拥有全球权益的小分子和抗体管线。公司的主要候选产品CBP-201是一种针对白介素-4受体α亚基(IL-4Rα)的全人源抗体，目前正在进行治疗特应性皮炎(AD)和哮喘的临床试验。公司的第二个主要候选产品CBP-307是一种T细胞受体的调节剂，该受体称为1-磷酸鞘氨醇受体1 (S1P1)，目前正在评估其治疗溃疡性结肠炎(UC)的效果。此外，公司的第三个主要候选药物CBP-174是一种组胺受体3的外周限制性拮抗剂，正在开发用于治疗与皮肤炎症有关的瘙痒症。

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前瞻性声明

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This analysis was based on 255Chinese patients with moderate and severe AD. The results of the 16th week study successfully reached the primary end point and all the key secondary end points, and the difference was highly significant.
Consistent with similar drugs targeting IL-4R α, CBP-201 is safe and well tolerated.
The findings support further discussions with CDE on the submission of NDA in China.
The company will communicate the relevant results by teleconference at 5: 30 a.m. Pacific time today / 8:30 EDT

Jiangsu TaicangOctober 5, 2022/ PR Newswire /-- Connect Biopharma Holdings Ltd. Co., Ltd. (Nasdaq: CNTB, hereinafter referred to as "Conrad" or "the Company"), a biomedical company with clinical products and a global layout, develops innovative therapies through a self-developed T cell function regulation platform to improve the quality of life of patients with chronic inflammatory diseases. The company today announced the top-line results of key clinical trials of its main drug candidate CBP-201 in Chinese patients with moderate and severe atopic dermatitis (AD). The multicenter, randomized, double-blind, parallel, placebo-controlled trial was designed to assess the efficacy and safety of CBP-201 and to assess the possibility of extending the interval between CBP-201 administration through maintenance treatment.

At the 16th week, the percentage of subjects in the CBP-201 treatment group (300mg, given biweekly) reached the main end point (IGA score 0 or 1 and ≥ 2 points lower than the baseline, equivalent to "clearance" or "basic clearance" of skin lesions) was significantly higher than that in the placebo group (30.3 vs 7.5%; p

The overall tolerance of CBP-201 was good, and the safety outcome was similar to that of placebo: during the 16-week treatment, the incidence of TEAE (therapeutic adverse events) was 73.5% in the CBP-201 treatment group and 72.9% in the placebo group. The incidence of SAE (severe adverse events) in the CBP mai 201 treatment group was 0.6%, and 3.5% in the placebo group. Most TEAE had mild to moderate severity and did not lead to drug withdrawal in the study. The most common AESI (adverse events of particular concern) during the treatment period in the study were injection site reactions lasting more than 24 hours (6.5% in the CBP-201 group and 0% in the placebo group, with mild severity in all these injection sites) and conjunctivitis (4.7% in the CBP-201 group and 3.5% in the placebo group).

"We treat patients with this intractable disease every day, and the symptoms of the disease include persistent strong itching, pain, erythema, dryness, exudation, scabs and skin cracking in the lesions." Professor Zhang Jianzhong, director of dermatology at Renmin Hospital of Peking University, who led the study, said, "the main results from the largest clinical study of atopic dermatitis in China to date are impressive, and this safe and effective treatment also brings new hope for patients. We look forward to new options for the treatment of AD in the near future to meet the needs of more AD patients."

"I am pleased to see that important positive results from key clinical trials in China provide CBP-201 with efficacy and safety data that can be used to support NDA." Dr. Zheng Wei, co-founder and CEO of Cornell, said, "the ongoing phase II study will provide us with an important opportunity to assess the long-term efficacy of CBP-201, including the continuation of the current fortnightly administration (Q2W) and a more convenient four-week administration (Q4W) in our global phase 2b trial. Q4W also showed significant improvements in skin clearance, disease severity and itching. "

The company plans to communicate with CDE (Drug Review Center of the State Drug Administration) in the coming months to discuss the possibility of NDA submission after the trial is completed.

Teleconference and webcast information

Please choose the following methods to join today's teleconference or webcast starting at 5: 30 a.m. Pacific time / 8:30 EDT:

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About this clinical trial

The Chinese key Clinical trial (NCT05017480) of CBP-201 in the treatment of moderate and severe atopic dermatitis is an ongoing multicenter, randomized, double-blind, parallel, placebo-controlled trial. The main purpose of the study is to evaluate the efficacy and safety of drugs. The study will be divided into two phases. Participants in the group were randomly treated with CBP-201 or placebo at 2:1. During the first phase of the 16-week study, subjects in the CBP-201 treatment group received a loading dose of 600mg on the first day, followed by biweekly administration of 300mg (Q2W). Subjects in the placebo control group received matching placebos. At the end of the first stage of treatment, the subjects who reached EASI-50 were randomly divided into two groups according to the ratio of 1: 1. During the second stage of maintenance therapy (36 weeks), they received biweekly administration of CBP-201 300mg (Q2W) or administration of CBP-201 300mg every four weeks (Q4W). Patients who do not reach EASI-50 during the first stage of treatment will receive biweekly administration of CBP-201 300mg (Q2W) during the second stage of treatment.

This analysis is based on the requirements of CDE, based on the completion of phase 1 of 255 adult patients (the main analysis population). On the basis of this analysis, the company also plans to communicate with CDE to determine whether additional analysis is needed for adults and adolescents who participated in the trial other than the main analysis group.

About atopic dermatitis andCBP-201

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, characterized by destruction of skin barriers and abnormal immune regulation. The lifetime prevalence rate is about 20%, and is on the rise worldwide. The estimation of the prevalence of AD in China shows that the prevalence of AD is gradually increasing with the passage of time. A recent longitudinal study showed that among outpatients in tertiary hospitals in China, the prevalence rate of AD diagnosed by dermatologists was 7.8%. In the United States, an estimated 26.1 million people have AD, of which 6.6 million have a moderate to severe disease. In addition, the existing treatments (including topical anti-inflammatory drugs and systemic drugs) can not effectively control the symptoms of more than 58% of moderate and severe AD patients.

CBP-201 is an antibody drug targeting IL-4R α (interleukin-4 receptor α subunit). IL-4R α is an effective target for the treatment of many Th2 inflammatory diseases, including AD. The results of a phase 2b global multicenter clinical trial for adult patients with moderate to severe AD show that CBP-201 is safe and effective.

About Connect Biopharma Holdings Ltd.

Cornell, a biomedical company with clinical products operating in the United States and China, develops innovative therapies through a self-developed T cell function regulation platform to improve the quality of life of patients with inflammatory immune diseases. The company uses functional cell testing of T cells to screen and identify effective candidates for effective immune targets in order to establish a rich pipeline of independently developed small molecules and antibodies with global interests. The company's main candidate product, CBP-201, is an all-human antibody against the interleukin-4 receptor alpha subunit (IL-4R α), which is currently in clinical trials for the treatment of atopic dermatitis (AD) and asthma. The company's second major candidate, CBP-307, is a regulator of the T cell receptor, sphingosine 1-phosphate receptor 1 (S1P1), which is currently evaluating its efficacy in the treatment of ulcerative colitis (UC). In addition, the company's third major drug candidate, CBP-174, is a peripheral restricted antagonist of histamine receptor 3, which is being developed for the treatment of pruritus associated with skin inflammation.

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Forward-looking statement

Connect Biopharma Holdings Ltd. reminds you that statements not described by historical facts contained in this press release are forward-looking statements. Such statements usually contain words such as "may", "can", "will", "will", "should", "expect", "plan", "expect", "believe", "estimate", "intend", "predict", "seek", "consider", "potential", "continue" or "plan" or other similar terms. These statements include the company's plans to advance the development of candidate products, the timing of achieving any development or regulatory milestones, and the potential of such candidates, including achieving any efficacy or drug properties or obtaining any product approval. This forward-looking statement contained herein shall not be construed as a statement by Connect Biopharma Holdings Ltd. that any of its plans will be realized. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Connect Biopharma Holdings Ltd. 's business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"), including the Company's annual results report on form 20murf and other reports filed with the Securities and Exchange Commission on March 31, 2022. Investors should be careful not to rely too much on such forward-looking statements, which only represent the date of this press release and Connect Biopharma Holdings Ltd. is under no obligation to revise or update this press release to reflect events or circumstances after its release. More information about these and other risks is included in Connect Biopharma Holdings Ltd. 's documents to SEC, which are available on the SEC website (www.sec.gov) and the "investors" section of Connect Biopharma Holdings Ltd. 's website. All forward-looking statements are subject to this cautionary statement. This warning statement is made in accordance with the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

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康乃德生物医药宣布CBP-201治疗中重度特应性皮炎的中国关键临床试验成功达到了主要终点和所有关键次要终点

Connect Biopharma Holdings Ltd. announced that China's key clinical trials of CBP-201 in the treatment of moderate and severe atopic dermatitis have successfully reached the primary end point and all key secondary end points.

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