Cocrystal Pharma开始为香港2a期研究CC-31244治疗丙型肝炎病毒超短

StephenW

Cocrystal Pharma Commences Patient Enrollment for Hong Kong Phase 2a Study of CC-31244 for Ultra-Short Treatment of Hepatitis C Virus
May 20, 2019

- Humanity & Health Research Centre conducting differentiated Phase 2a study evaluating CC-31244 for the ultra-short treatment of hepatitis C (HepC)

- Asia market represents one of the largest HepC virus carrier populations in the world

BOTHELL, WA, May 20, 2019 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, announced today that it has commenced patient enrollment in its Phase 2a study in Hong Kong SAR, China.

The Phase 2a open-label study being conducted at Humanity & Health Research Centre, Humanity and Health Medical Group, in Hong Kong will evaluate the safety, tolerability and preliminary efficacy of Cocrystal’s CC-31244 in combination with Sofosbuvir and Daclatasvir with or without a protease inhibitor, for the treatment of hepatitis C (HepC). Sixteen patients will be enrolled in the Phase 2a study. This trial differs from the current Phase 2a trial Cocrystal is conducting in that testing will include for the first time a protease inhibitor.

Dr. George Lau commented, “We are pleased to commence patient enrollment in this important, differentiated Phase 2a study. I believe CC-31244 has the potential to be a shorter, safer and more effective treatment option for treating hepatitis C in the Asian population and where there remains a significant unmet need.”

Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal stated, “The commencement of patient enrollment in this Phase 2a study represents a noteworthy accomplishment in our clinical development program for CC-31244. We are pleased to be working with the Humanity & Health Research Centre in Hong Kong and believe this study will provide valuable insight in this important market, representing one of the largest hepatitis C virus carrier populations in the world. We look forward to further understanding the potential to change the treatment paradigm for patients living with HCV by providing an ultra-short therapy to enhance the existing HepC combination therapies.”

Under the Clinical Trial Agreement, the Phase 2a study of CC-31244 for the treatment of HepC will be sponsored and conducted by the Humanity & Health Research Centre, Hong Kong under the guidance of George Lau, M.D., FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD, Founding Chairman of Humanity and Health Medical Group, Hong Kong. As part of the agreement, Cocrystal will provide CC-31244, its lead product in development for HepC. Cocrystal’s CC-31244 is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). It has a high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. It is active against HCV genotypes 1-6 with no significant cytotoxicity in multiple cell types at high concentrations.
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StephenW

Cocrystal Pharma开始为香港2a期研究CC-31244治疗丙型肝炎病毒超短期患者的患者入组
2019年5月20日

- 人类与健康研究中心开展差异化2a期研究，评估CC-31244对丙型肝炎的超短期治疗（HepC）

- 亚洲市场是世界上最大的HepC病毒携带者之一

华盛顿州BOTHELL，2019年5月20日（GLOBE NEWSWIRE） -  Cocrystal Pharma，Inc。（纳斯达克股票代码：COCP），（“Cocrystal”或“公司”），一家发现和开发新型抗病毒疗法的临床阶段生物技术公司，今天宣布它已开始在中国香港特区进行2a期研究。

在香港人类与健康医疗集团人类与健康研究中心进行的2a期开放标签研究将评估Cocrystal的CC-31244与Sofosbuvir和Daclatasvir联合使用或不使用蛋白酶的安全性，耐受性和初步功效抑制剂，用于治疗丙型肝炎（HepC）。 16名患者将参加2a期研究。该试验与目前的Cocrystal进行的2a期试验不同，该试验将首次包括蛋白酶抑制剂。

George Lau博士评论说：“我们很高兴在这项重要的，有区别的2a期研究中开始患者入组。我相信CC-31244有可能成为一种更短，更安全，更有效的治疗方案，可以治疗亚洲人群中的丙型肝炎，并且仍然存在严重的未满足需求。“

Cocrystal董事长兼首席执行官Gary Wilcox表示，“这项2a期研究中患者登记的开始，是我们CC-31244临床开发计划中值得注意的成就。我们很高兴与香港人文与健康研究中心合作，相信这项研究将为这个重要的市场提供宝贵的见解，代表着世界上最大的丙型肝炎病毒携带者群体之一。我们期待通过提供超短疗法来增强现有的HepC联合疗法，进一步了解改变HCV患者治疗范式的潜力。“

根据临床试验协议，CC-31244用于治疗HepC的2a期研究将由香港人道与健康研究中心在George Lau，MD，FRCP（Edin，Lond）的指导下赞助和进行， FHKAM（Med），FHKCP，FAASLD，香港人道与健康医疗集团创始主席。作为协议的一部分，Cocrystal将提供CC-31244，它是HepC开发的主要产品。 Cocrystal的CC-31244是一种研究性，口服，有效的广谱复制抑制剂，称为非核苷抑制剂（NNI）。它使用公司专有的基于结构的药物发现技术设计和开发具有很高的耐药性障碍。它对HCV基因型1-6具有活性，在高浓度的多种细胞类型中没有显着的细胞毒性。