Replicor公开了在AASLD 2017的REP 401研究中，80％的慢性乙型肝炎

antiHBVren

乐观其成！ 看最后谁最先到达 Phase III
这是HBV基金组织目前各个治疗措施的进展
http://www.hepb.org/treatment-and-management/drug-watch/

hp121

回复 antiHBVren 的帖子

是否都经过FDA认可？？

尤其是REP公司

StephenW

Most patients achieve control of HBV with combined interferon therapy
October 24, 2017

WASHINGTON — Replicor announced interim follow-up data from the REP 401 protocol, an ongoing evaluation of the company’s REP 2139 combined with tenofovir disoproxil fumarate with pegylated interferon alpha 2a as a treatment for patients with hepatitis B, according data presented at The Liver Meeting 2017.

REP 2139-based combination has for the first time achieved functional control or cure in a very high proportion of patients. Equally as important is the normalization of liver function in the absence of therapy, even in patients with significant liver enzyme elevation before treatment began. Andrew Vaillant, PhD, chief scientific officer at Replicor, told Healio Gastroenterology and Liver Disease. “Replicor believes this interim follow-up data from the REP 401 trial clearly demonstrates that REP 2139 will become the indispensable backbone of future combination therapies.”

Early data from the REP 401 protocol showed that eight of 10 patients with HBV achieved functional control of infection at the end of treatment with combined REP 2139, tenofovir disoproxil fumarate and pegylated interferon alpha 2a. Specifically, these eight patients had HBsAg below 1 IU/mL and HBV DNA below 10 IU/mL.

Therapeutic liver flares and anti-HBsAg antibody levels up to 223,055 mIU/mL accompanied functional control.

Functional control persisted after removal of all parts of therapy with data from 24 weeks in four patients and 12 weeks in four patients. The most recent data showed that four patients achieved HBsAg loss and HBV DNA below 1,000 copies per mL for 6 months after treatment ended.

“Replicor’s current REP 401 protocol will continue to track the functional control of patients for 48 weeks after removal of therapy,” Vaillant said. “After this follow-up, patients will be enrolled in a long term surveillance trial similar to the one currently underway following completion of our REP 301 trial in HBV/HDV coinfection.”

Reference: www.replicor.com

大多数患者通过联合干扰素治疗可以控制HBV
2017年10月24日

华盛顿 - Replicors公布了REP 401协议的临时随访数据，该公司REP 2139联合替诺福韦地氟米芬富马酸与聚乙二醇化干扰素α2a作为乙型肝炎患者的治疗数据进行了持续评估。 。

基于REP 2139的组合首次在非常高比例的患者中实现了功能控制或治愈。在没有治疗的情况下肝脏功能正常化同样重要，即使在治疗开始前肝脏酶升高显着的患者中也是如此。 Replicor首席科学家Andrew Vaillant博士告诉Healio Gastroenterology and Liver Disease。 “Replicors认为REP 401临床试验的临时数据清楚地表明REP 2139将成为未来联合治疗不可或缺的支柱。”

REP 401方案的早期数据表明，10例HBV患者中有8例在治疗结束时接受了REP 2139，替诺福韦地索普西富马酸和聚乙二醇化干扰素α2a治疗的感染功能控制。具体来说，这8名患者的HBsAg低于1 IU / mL，HBV DNA低于10 IU / mL。

治疗性肝脏耀斑和抗HBsAg抗体水平高达223,055 mIU / mL伴随功能控制。

在4例患者和24例患者中，24周的资料清除了所有治疗部位后，功能控制仍然持续。最新数据显示，治疗结束后6个月，4例HBsAg损失和HBV DNA低于1000拷贝/ mL。

Vaillant说：“复制者目前的REP 401协议将继续追踪患者在治疗48周后的功能控制。 “在这项后续行动之后，患者将参加一项长期监测试验，类似于目前正在进行的在HBV / HDV合并感染的REP 301试验完成后。

参考：www.replicor.com

https://www.healio.com/hepatolog ... -interferon-therapy

StephenW

Tiny hep B drug combo study touts potential of a ‘functional cure’ at little-known Replicor

by John Carroll — on October 24, 2017 09:29 AM EDT       

  
A small, largely unknown biotech in Canada is reporting some remarkable results from a tiny proof-of-concept study for a new hep B combo.

Reporting at the American Association for the Study of Liver Disease meeting in Washington, DC, investigators for the Montreal-based Replicor say that they tracked a persistent functional cure for 4 of the handful of patients being treated with a combination therapy. And 8 of 10 patients have achieved what they term “functional control” over the disease.

Andrew Vaillant, Replicor

The combo matches an in-house drug dubbed REP 2139 with tenofovir disoproxil fumarate and pegylated interferon alpha 2a. Without the proprietary drug, the researchers say that patients can expect a 10% response. And they’re now setting the stage for a bigger trial to put their drug to a more ambitious test.

Their definition of functional control was the reduction of hepatitis B surface antigens to less than one IU/mL and viral DNA levels of less than 10 IU/mL. This was an open-label study with no control arm.

Not much has been reported about this private biotech company, including any details on how it’s been financed since it was founded in 2009.

Replicor CSO Andrew Vaillant had this to say in a prepared statement:

    The addition of REP 2139’s unique ability to clear circulating HBsAg improves this outcome in a striking fashion, achieving functional control in 80% of patients not only during treatment but persisting after treatment is withdrawn. Equally important is the normalization of liver function during follow-up in all these patients, even those with significantly elevated liver enzymes at the start of therapy.

Tiny hep B药物组合研究在不太了解的Replicor上展示了“功能治疗”的潜力

由John Carroll于2017年10月24日09:29 EDT

  
在加拿大，一个很小的，很大程度上未知的生物科技报道了一项关于一种新型肝B组合的微观概念研究的一些显着成果。

在美国华盛顿特区美国肝病研究协会报告中，位于蒙特利尔的复发者的调查人员说，他们跟踪了联合治疗治疗的少数患者中有4例的持续功能治疗。 10例患者中有8例达到了他们对疾病的“功能控制”。

副总裁Andrew Vaillant

该组合匹配了一种名为REP 2139的内部药物，与替诺福韦地索普利富马酸酯和聚乙二醇化干扰素α2a匹配。没有专利药物，研究人员说，患者可以预期10％的反应。他们现在正在为更大的审判奠定基础，使其药物进行更为雄心勃勃的测试。

他们对功能控制的定义是将乙型肝炎表面抗原减少到小于1 IU / mL，病毒DNA水平低于10 IU / mL。这是一个没有控制臂的开放标签研究。

这家私营生物技术公司没有多少报道，包括自2009年成立以来如何融资的任何细节。

复制人CSO Andrew Vaillant在准备的声明中表示：

    补充REP 2139独特的清除循环HBsAg的能力以惊人的方式改善了这一结果，80％的患者不仅在治疗期间进行功能控制，而且在治疗结束后仍然存在。所有这些患者的随访期间肝功能正常化同样重要，即使是在开始治疗时肝酶显着升高的患者。

https://endpts.com/tiny-hep-b-dr ... tle-known-replicor/

hp121

在加拿大，一个很小的，很大程度上未知的生物科技