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标题: Replicor宣布发布其最新的临床前乙型肝炎研究:REP 2139和TDF / E [打印本页]

作者: StephenW    时间: 2017-12-21 08:15     标题: Replicor宣布发布其最新的临床前乙型肝炎研究:REP 2139和TDF / E

[p=23, null, center]Replicor announces publication of its latest pre-clinical hepatitis B study: REP 2139 and TDF/ETV combine synergistically to establish control of cccDNA in the liver

[p=23, null, left]MONTREAL, December 20, 2017 – Replicor Inc., a privately held biopharmaceutical company targeting a functional cure for patients with chronic HBV infection and HBV / HDV co-infection announced today the publication of its in vivo study examining the efficacy of REP 2139 combined with tenofovir disoproxil fumarate (TDF) or TDF and entecavir (ETV) in the journal Hepatology.

[p=23, null, left](http://onlinelibrary.wiley.com/doi/10.1002/hep.29737/abstract;jsessionid=DBEE57F4C746220D326EE1ADC1535D88.f03t04).

[p=23, null, left]Conducted in collaboration with Dr. Lucyna Cova at the Institut National de Santé et Recherche Médicale (INSERM) U1052 in Lyon, France, this study examined the antiviral effects of combined therapy with the nucleic acid polymer (NAP) REP 2139 and TDF or TDF and ETV in the duck model of HBV infection.  Several previously published studies have demonstrated the utility of this animal model to reliably predict the effects of NAPs in clinical studies, with the most recent of these studies indicating that the production of HBV subviral particles in human infection, the targeting of which is critical for achieving functional remission of HBV infection, are also uniquely reproduced in this model.

[p=23, null, left](http://www.sciencedirect.com/science/article/pii/S016635421730596X).

[p=23, null, left]In the current study, combining REP 2139 with TDF or TDF and ETV produced a synergistically enhanced antiviral response, with faster on-treatment clearance of surface antigen and viral DNA, increased rates of functional remission of hepadnaviral infection after removal of therapy and most importantly, clearance of surface antigen from the liver and a synergistic enhancement in the inactivation and/or clearance of cccDNA in the liver after removal of therapy, findings which were verified by Southern blot.

[p=23, null, left]Dr. Andrew Vaillant, CSO of Replicor commented, “We are excited by these findings as they clearly suggest that combining REP 2139 with TDF, ETV or other latest generation tenofovir derivatives, such as tenofovir alafenamide and tenofovir exalidex, will have a synergistic effect on establishing control of cccDNA in the liver in the absence of immunotherapy.  These results suggest that the functional remission of HBV infection, which we can now achieve in patients with finite therapy with REP 2139, TDF and pegylated interferon, may be achievable in some patients in the absence of immunotherapy.”


作者: StephenW    时间: 2017-12-21 08:15

Replicor宣布发布其最新的临床前乙型肝炎研究:REP 2139和TDF / ETV联合协同建立肝脏中cccDNA的控制

2017年12月20日,蒙特利尔 - Replicor Inc.是一家私人持有的生物制药公司,针对慢性HBV感染和HBV / HDV合并感染患者的功能性治疗,今天宣布发布其体内研究,检查REP 2139替诺福韦二吡呋酯富马酸盐(TDF)或TDF和恩替卡韦(ETV)在“肝脏病学”(Hepatology)期刊中。

http://onlinelibrary.wiley.com/doi/10.1002/hep.29737/abstract;jsessionid=DBEE57F4C746220D326EE1ADC1535D88.f03t04)。

本研究与法国里昂国立卫生研究院(INSERM)U1052国家研究所的Lucyna Cova博士合作,研究核酸聚合物(NAP)REP 2139和TDF或TDF联合治疗的抗病毒作用, ETV在鸭乙型肝炎病毒感染中的作用。以前发表的几项研究已经证明了这种动物模型在临床研究中可靠地预测NAP的效果,最近的这些研究表明在人类感染中产生HBV亚病毒颗粒,其靶向对于实现HBV感染的功能缓解,在这个模型中也被独特地转载。

http://www.sciencedirect.com/sci ... i/S016635421730596X)。

在当前的研究中,将REP 2139与TDF或TDF和ETV联合产生协同增强的抗病毒应答,表面抗原和病毒DNA的治疗中清除更快,除去治疗后嗜肝病毒感染的功能缓解率增加,最重要的是,从肝脏清除表面抗原和在除去治疗后肝脏中cccDNA的失活和/或清除中的协同增强,这些发现通过Southern印迹证实。

Replicor的CSO Andrew Vaillant博士评论说:“我们对这些发现感到兴奋,因为他们清楚地表明,将REP 2139与TDF,ETV或其他最新一代的替诺福韦衍生物(如替诺福韦艾拉酚胺和替诺福韦exalidex)相结合可以产生协同作用在没有免疫治疗的情况下建立对肝脏中cccDNA的控制。这些结果表明,在没有免疫治疗的情况下,一些患者可以实现在REP 2139,TDF和聚乙二醇干扰素有限疗法的患者中实现的HBV感染的功能缓解。
作者: hchu    时间: 2017-12-21 09:37

问题是,为什么不马上上市2139?先建立解放区,再解放全中国嘛。
作者: StephenW    时间: 2017-12-21 09:44

回复 hchu 的帖子

上市需要国家政府批准, 哪个国家?
作者: windu    时间: 2017-12-21 10:28

回复 StephenW 的帖子

我的个人市场许可它对我上市,哈哈,我想二千万人的个人市场对它进行批准,那就是二千万大市场
作者: hchu    时间: 2017-12-21 11:45

“在没有免疫治疗的情况下建立对肝脏中cccDNA的控制”。这不是基本解决问题了吗?好像好消息太多了点。
作者: StephenW    时间: 2017-12-21 12:54

回复 hchu 的帖子

这不是基本解决问题了吗? 到目前为止,只有在动物模型中
好像好消息太多了点 -  已知多年REP9AC的HBsAg阻断效应, 但这可以持续下去,并导致永久治愈还是一个未知数. REP9AC + ETV/TDF + 干扰素可以, REP9AC + ETV/TDF ?




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