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标题: REP 301-LTF和REP 401研究中基于NAP的联合治疗期间和之后HBsAg水平 [打印本页]

作者: StephenW    时间: 2020-9-28 18:18     标题: REP 301-LTF和REP 401研究中基于NAP的联合治疗期间和之后HBsAg水平

                                                                                                                                                                                                                           

Analysis of HBsAg levels, HBsAg immune complexes, HBV pregenomic RNA andHBcrAg dynamics during and after NAP-based combination therapy in the REP301-LTF and REP 401 studies

   Analysis of HBsAg levels, HBsAg immune complexes, HBV pregenomic RNA andHBcrAg dynamics during and after NAP-based combination therapy in the REP301-LTF and REP 401 studies

EASL 2020 Aug 27-29 virtual - see LBP below following announcement

Replicor announces presentation of experimental endpoint data at EASLMONTREAL, September 10th, 2020 - Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the late breaking presentation of experimental endpoint data from its most recent REP 301/301-LTF and REP 401 studies at the Digital ILC 2020.

Conducted in collaboration with Abbott Diagnostics, a variety of experimental virologic markers were analyzed during therapy and follow-up after treatment with NAP-based combination therapy in HBeAg HBV / HDV co-infection (REP 301/301-LTF) and HBeAg negative HBV infection (REP 401).  These included ultralow HBsAg (<0.005 IU/mL), HBV pgRNA, HBcrAg and HBsAg immune complexes..

During NAP-based therapy, HBsAg clearance was shown to extend to < 0.005 IU/mL with clearance of both HBV RNA and HBcrAg.  All of these experimental milestones were maintained in patients with functional cure of HBV.  HBsAg immune complexes declined early in therapy and this decline generally continued throughout therapy and universally during follow-up in participants with functional cure..

Replicor's CSO, Dr. Andrew Vaillant commented, "These experimental endpoint data demonstrate not only the very effective nature of HBsAg clearance with NAP-based therapy, but also the effective silencing and or erosion of cccDNA.  They also demonstrate the profound control of infection in patients that achieve functional cure with NAPs.   We are also very encouraged by the absence of HBsAg immune complexes in participants with functional cure, which strongly suggests the efficient removal of integrated HBV DNA from the liver.".

Replicor's presentation is available on the company's website at www.replicor.com/science/conference-presentations.  For further information about the Digital ILC 2020: https://ilc-congress.eu/ .

About Replicor
Replicor is a privately held biopharmaceutical company with the most advanced animal and human clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV co-infection. For further information about Replicor please visit our website at www.replicor.com..

Ongoing analysis of virologic control / functional cure of HBV and HDV infection following REP 2139-Ca and pegylated interferon alpha-2a therapy in patients with chronic HBV / HDV co-infection: 3.5-year follow-up results from the REP 301-LTF study .

Replicor announces publication of the REP 401 study achieving high rates of virologic control and functional cure in patients with chronic hepatitis B infection.


Analysis of HBsAg levels, HBsAg immune complexes, HBV pregenomic RNA andHBcrAg dynamics during and after NAP-based combination therapy in the REP301-LTF and REP 401 studies..

M. Bazinet1, M Anderson2, V. Pântea3, G. Placinta3, I. Moscalu4, V. Cebotarescu3, L. Cojuhari3, P. Jimbei5, L.Iarovoi3, V. Smesnoi5, T. Musteata5, A. Jucov3,4, J. Gersch2, V. Holzmayer2, M. Kuhns2, G. Cloherty2, A. Vaillant11. Replicor Inc. Montreal, Canada, 2. Abbott Diagnostics, Abbott Park, Illinois, USA, 3. Department of Infectious Diseases, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Republic of Moldova, 4. ARENSIA Exploratory Medicine, Republican Clinical Hospital, Chisinau, Republic of Moldova, 5. Toma Ciorba Infectious Clinical Hospital, Chisinau, Republic of Moldova

  

  
  

  
                                         

作者: StephenW    时间: 2020-9-28 18:18

REP 301-LTF和REP 401研究中基于NAP的联合治疗期间和之后HBsAg水平,HBsAg免疫复合物,HBV前基因组RNA和HBcrAg动态的分析


  REP 301-LTF和REP 401研究中基于NAP的联合治疗期间和之后HBsAg水平,HBsAg免疫复合物,HBV前基因组RNA和HBcrAg动态的分析

EASL 2020 8月27-29日虚拟-公告后见下方的LBP

Replicor于2020年9月10日在EASL MONTREAL上宣布实验终点数据的展示-一家私有生物制药公司Replicor Inc.针对慢性乙型和D型肝炎感染患者的功能性治疗,宣布了最新的实验终点数据的最新展示最近在Digital ILC 2020上进行的REP 301 / 301-LTF和REP 401研究。

在与Abbott Diagnostics合作进行的治疗过程中以及在基于NAP的联合治疗HBeAg HBV / HDV合并感染(REP 301 / 301-LTF)和HBeAg阴性HBV感染的治疗过程中和随访后分析了多种实验病毒学标志物(REP 401)。其中包括超低HBsAg(<0.005 IU / mL),HBV pgRNA,HBcrAg和HBsAg免疫复合物。

在基于NAP的治疗过程中,随着HBV RNA和HBcrAg的清除,HBsAg清除率可扩展至<0.005 IU / mL。 HBV功能治愈的患者均保持了所有这些实验性里程碑。 HBsAg免疫复合物在治疗早期下降,并且这种下降通常在整个治疗过程中以及在具有功能性治愈的参与者的随访期间普遍持续。

复制者的CSO Andrew Vaillant博士评论说:“这些实验终点数据不仅证明了基于NAP的疗法清除HBsAg的非常有效的性质,而且还证明了cccDNA的有效沉默和/或侵蚀。它们还证明了感染的深层控制。通过NAP达到功能性治愈的患者。功能性治愈的参与者缺乏HBsAg免疫复合物,这也使我们感到非常鼓舞,这强烈表明从肝脏中有效清除了整合的HBV DNA。”

Replicor的演示文稿可以在公司的网站上找到,网址为www.replicor.com/science/conference-presentations。有关Digital ILC 2020的更多信息,请访问:https://ilc-congress.eu/

关于复制品
Replicor是一家私有生物制药公司,在开发HBV和HDV的治疗方法方面拥有最先进的动物和人类临床数据。该公司致力于加快针对HBV和HBV / HDV合并感染患者的有效治疗方法的开发。有关Replicor的更多信息,请访问我们的网站www.replicor.com

对REP 2139-Ca和聚乙二醇化干扰素α-2a治疗慢性HBV / HDV合并感染的患者进行病毒学控制/功能治愈的持续分析:REP 301-LTF研究的3.5年随访结果。

Replicor宣布发布REP 401研究,该研究在慢性乙型肝炎患者中实现了较高的病毒学控制和功能治愈。


0918201
在REP 301-LTF和REP 401研究中基于NAP的联合治疗期间和之后,对HBsAg水平,HBsAg免疫复合物,HBV前基因组RNA和HBcrAg动态进行分析。

M. 。Gersch2,V. Holzmayer2,M. Kuhns2,G. Cloherty2,A. Vaillant1 1. Replicor Inc.加拿大蒙特利尔,2.美国雅培诊断公司,美国伊利诺伊州雅培公园,3.尼古拉·Testemitanu国立大学传染病系摩尔多瓦共和国基希讷乌医学与药学学院,4.摩尔多瓦共和国基希讷乌共和临床医院ARENSIA探索医学,5.摩尔多瓦共和国基希讷乌Toma Ciorba传染性临床医院

作者: 齐欢畅    时间: 2020-9-28 23:20

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