ContraVir制药公司在首次人体试验中启动CRV431剂量

StephenW

ContraVir Pharmaceuticals Initiates Dosing of CRV431 in First In-Human Trial
Corporate, Business and Clinical Update Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET
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June 25, 2018 08:00 ET | Source: ContraVir Pharmaceuticals Inc.

EDISON, N.J., June 25, 2018 (GLOBE NEWSWIRE) -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (HBV), announced today dosing of the first subject in its single ascending dose (SAD) Phase 1 trial in the United States with cyclophilin inhibitor, CRV431.  

The randomized, partially-blinded, placebo-controlled ascending sequential dose group study will assess safety, tolerability and pharmacokinetics (PK) of CRV431 in healthy volunteers as part 1 of the first clinical study. Part two of the clinical trial will consist of a single dose of CRV431 in a drug to drug interaction study assessing the safety, tolerability and PK co-administered with Viread® (tenofovir disoproxil fumarate), and part three of the study will assess the safety, tolerability, PK and preliminary signal for antiviral efficacy of CRV431 in stable HBV patients already treated with Viread®.

“Data from completed pre-clinical studies have indicated that CRV431 complements current hepatitis B treatments by reducing multiple markers of infection including HBV DNA, HBsAg, HBeAg, binding of HBx, and HBV active uptake by cells,” said James Sapirstein, Chief Executive Officer. “With the FDA’s approval for an accelerated clinical program for CRV431, coupled with the positive pre-clinical efficacy profile seen to date, we are extremely excited in defining and developing CRV431’s path forward as we continue our efforts in addressing the need for a functional cure for chronic hepatitis B infection. Importantly, findings from the multi-dose pilot phase of the study conducted in HBV patients will be used to establish a recommended dose range for CRV431 for future clinical trials and will help define potential combination approaches that could ultimately lead us to a functional cure.”

Conference Call Information:

Interested participants and investors may access the conference call by dialing 1 (409) 983-9733 or 1 (844) 535-3939 and providing audience code 1042879.

An audio webcast will be accessible via the Investors section of ContraVir’s website at http://ir.contravir.com/investor-relations.  An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m., ET on June 25, 2018.

About CRV431

CRV431 is a non-immunosuppressive analog of cyclosporine A (CsA) whose primary biochemical action is inhibition of cyclophilin isomerase activity, playing a key role in protein folding. Other viruses such as HIV-1 and HCV, similarly use cyclophilin for their replication. In pre-clinical studies, CRV431 has shown potential in experimental models to complement current hepatitis B treatments by reducing multiple markers of infection including HBV DNA, HBsAg, HBx, HBeAg, and HBV uptake by cells. Studies have also demonstrated that CRV431 reduces the progression of fibrosis in an animal model and also reduces both the number and size of liver tumors in a hepatocellular carcinoma (HCC) model.

About ContraVir Pharmaceuticals

ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with a specific focus on developing a potentially curative therapy for hepatitis B virus (HBV). The company is developing two novel anti-HBV compounds with complementary mechanisms of action. TXL™, a nucleoside analog lipid prodrug of tenofovir (TFV), is designed to deliver higher hepatic intracellular concentrations of the active tenofovir species (tenofovir diphosphate) while reducing concentrations of tenofovir outside the liver, causing fewer off-target toxicities and side-effects. CRV431, the other anti-HBV compound, is a next-generation cyclophilin inhibitor with a novel structure that increases its potency and selective index against HBV. In vitro and in vivo studies have thus far demonstrated that CRV431 reduces HBV DNA and other viral proteins, including surface antigen (HBsAg). For more information visit www.contravir.com.

StephenW

ContraVir制药公司在首次人体试验中启动CRV431剂量
企业，商业和临床更新电话会议和现场音频网络广播定于今天下午4:30举行。 ET
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2018年6月25日08:00 ET |来源：ContraVir制药公司

新泽西州艾迪逊，2018年6月25日电（GLOBE NEWSWIRE） - 一家专注于治疗乙型肝炎病毒（HBV）治疗药物开发和商业化的生物制药公司ContraVir制药公司（纳斯达克股票代码：CTRV）今天宣布，在美国使用cyclophilin抑制剂CRV431在其单次递增剂量（SAD）1期试验中给予第一个受试者。

作为第一项临床研究的第一部分，随机，部分盲法，安慰剂对照上升顺序剂量组研究将评估健康志愿者的CRV431的安全性，耐受性和药代动力学（PK）。临床试验的第二部分将包括一个药物与药物相互作用研究中的单剂量CRV431，评估安全性，耐受性和PK与Viread®（替诺福韦二吡呋酯富马酸盐）共同施用，第三部分研究将评估安全性，耐受性，PK和CRV431在已用Viread®治疗过的稳定HBV患者中抗病毒疗效的初步信号。

“来自完成的临床前研究的数据表明，CRV431通过减少多种感染标志物（包括HBV DNA，HBsAg，HBeAg，HBx的结合以及细胞对HBV的活性摄取）来补充现有的乙型肝炎治疗，”首席执行官James Sapirstein说。 。 “随着FDA批准CRV431加速临床计划，加上迄今为止所看到的积极的临床前疗效，我们对定义和开发CRV431的前进道路感到非常兴奋，因为我们继续努力解决功能性治疗的需求用于慢性乙型肝炎感染。重要的是，在HBV患者中进行的多剂量试验阶段的研究结果将用于建立CRV431的未来临床试验的推荐剂量范围，并将有助于确定可能最终导致我们进行功能性治疗的潜在联合方案。“

电话会议信息：

有兴趣的参与者和投资者可以通过拨打1（409）983-9733或1（844）535-3939并提供受众代码1042879来访问电话会议。

音频网络广播将通过ContraVir网站的投资者部分访问http://ir.contravir.com/investor-relations。网上直播档案将于2018年6月25日下午5:30左右开始持续90天。

关于CRV431

CRV431是环孢素A（CsA）的非免疫抑制类似物，其主要生化作用是抑制亲环蛋白异构酶活性，在蛋白质折叠中起关键作用。其他病毒如HIV-1和HCV同样使用亲环蛋白进行复制。在临床前研究中，CRV431通过减少多种感染标志物（包括HBV DNA，HBsAg，HBx，HBeAg和细胞对HBV的摄取）在实验模型中显示出补充现有乙型肝炎治疗的潜力。研究还表明，CRV431减少了动物模型中纤维化的进展，并且还降低了肝细胞癌（HCC）模型中肝肿瘤的数量和大小。

关于ContraVir制药公司

ContraVir是一家生物制药公司，专注于针对性抗病毒治疗的开发和商业化，并专门致力于开发针对乙肝病毒（HBV）的潜在治愈性治疗。该公司正在开发两种具有互补作用机制的新型抗HBV化合物。 TXL™是替诺福韦（TFV）的核苷类似物脂质前药，旨在提供更高的肝细胞内浓度的活性替诺福韦物质（替诺福韦二磷酸盐），同时降低肝脏外替诺福韦的浓度，导致更少的脱靶毒性和副作用。另一种抗-HBV化合物CRV431是新一代亲环蛋白抑制剂，具有增强其对HBV的效力和选择性指标的新结构。迄今为止，体外和体内研究已经证明CRV431减少了HBV DNA和其他病毒蛋白，包括表面抗原（HBsAg）。欲了解更多信息，请访问www.contravir.com。

newchinabok

不看好治愈hbv  只算是一个补充

默然10

这个比TAF 更高级。挺不错的药啊，希望早点进入市场。

灵魂不屈

也许这个药能成为联合用药的重要部分！

齐欢畅

灵魂不屈 发表于 2018-6-26 16:58
也许这个药能成为联合用药的重要部分！