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诺诚健华宣布完成ICP-488治疗银屑病的II期临床试验患者入组工作

InnoCare Announces the Completion of Patient Enrollment in the Phase II Clinical Trial of ICP-488 for the Treatment of Psoriasis

businesswire 等信源发布 2024-05-16 06:30

可切换为仅中文


BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, today announced the completion of patient enrollment for the phase II clinical trial of ICP-488, a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, for the treatment of psoriasis..

北京--(商业新闻短讯)--专注于治疗癌症和自身免疫性疾病的领先生物制药公司InnoCare Pharma(香港交易所:09969;苏格兰证券交易所:688428)今天宣布完成用于治疗牛皮癣的TYK2(酪氨酸激酶2)JH2变构抑制剂ICP-488的II期临床试验的患者登记。。

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment..

这是一项多中心,随机,双盲,安慰剂对照的II期临床研究,旨在评估ICP-488在中国成年中重度斑块型银屑病患者中的疗效,安全性,PK和PD特征。共有129名患者参加了这项研究。患者被随机分配到三个治疗组中的一个,比例为1:1:1,每天一次6mg组,每天一次9mg组和安慰剂组,连续治疗12周。。

ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. ICP-488 has demonstrated good efficacy and safety in the phase I study of treating psoriasis patients..

ICP-488是一种口服,有效和选择性的TYK2变构抑制剂。通过结合JH2结构域,ICP-488阻断IL-23,IL-12,1型IFN和其他炎性细胞因子的信号转导,从而抑制自身免疫和炎性疾病的病理过程。ICP-488在治疗银屑病患者的I期研究中显示出良好的疗效和安全性。。

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, “Psoriasis requires long-term management, and there is still a significant unmet demand for new drugs, especially oral medications in its treatment. We are very pleased to see the completion of patient enrollment in the phase II clinical trial for the treatment of psoriasis with ICP-488.

InnoCare联合创始人、董事长兼首席执行官Jasmine Cui博士表示:“牛皮癣需要长期管理,对新药的需求仍然很大,尤其是治疗中的口服药物。我们很高兴看到ICP-488治疗牛皮癣的II期临床试验完成了患者登记。

We remain committed to diligently advancing the clinical development of this promising therapy, with the goal of providing improved treatment options to psoriasis patients as soon as possible..

我们仍然致力于努力推进这种有前途的疗法的临床开发,目标是尽快为牛皮癣患者提供改进的治疗选择。。

Recent data indicates that approximately seven million people in China are currently living with psoriasis1, and this number is on the rise2. Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications.

最近的数据表明,中国目前约有700万人患有牛皮癣1,并且这个数字正在上升2。现有的治疗方案并没有完全满足受这种情况影响的人的需求,突出了现有治疗方法的巨大差距。对新型口服药物的需求特别迫切。

Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether3..

许多患者,尤其是中度至重度牛皮癣患者,仍然持续未得到治疗或未得到治疗3。。

About InnoCare

关于InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States..

InnoCare是一家商业化阶段的生物制药公司,致力于发现、开发和商业化一流和/或一流的药物,用于治疗中国和全球未满足医疗需求的癌症和自身免疫性疾病。InnoCare在北京、南京、上海、广州、香港和美国设有分公司。。

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1 Epidemiological Investigation on Psoriasis

1银屑病流行病学调查

2 2021. Progress in Epidemiological Investigation of Psoriasis, Journal of Diagnostics Concepts & Practice. 2021.

2021年。牛皮癣流行病学调查进展,诊断概念与实践杂志。2021

3 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2018). Chinese Journal of Dermatology. 2019. Research on the Situation of Psoriasis Healthcare in China based on the Global Monitoring Project of Psoriasis and the Causal Relationship between Psoriasis and Obesity and Type II Diabetes.

3中国银屑病诊断和治疗指南(2018)。中国皮肤病学杂志。2019年。基于牛皮癣全球监测项目以及牛皮癣与肥胖和II型糖尿病之间的因果关系,研究中国牛皮癣医疗保健状况。