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Replicor在APASL 2017年公开了使用NAP组合治疗的高HBsAg损失率 [复制链接]

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发表于 2017-2-20 22:39 |只看该作者 |倒序浏览 |打印
      

Media Contact:

Natacha Dorget
[email protected]
514-733-1998

Replicor discloses high rates of HBsAg loss with NAP combination therapy at APASL 2017

MONTREAL, Feb 20, 2017 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, presented an updated interim analysis from its latest REP 401 clinical trial at the Asia Pacific Association for the Study of Liver (APASL) held February 15-19, 2017 in Shanghai, China.

The REP 401 protocol (NCT02565719) is a randomized, controlled trial assessing the safety and efficacy of its first in class nucleic acid polymer (NAP) HBsAg release inhibitors, REP 2139 and REP 2165 in combination with tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha-2a (peg-IFN) in treatment naïve patients with chronic HBeAg negative HBV infection.

In patients receiving NAPs in combination with TDF and peg-IFN, 8/9 patients receiving REP 2139 have experienced HBsAg reductions > 4 logs with HBsAg loss (HBsAg ≤ 0.01 IU / ml) in 7 of these patients.  With REP 2165, a REP 2139 variant with improved tissue clearance, 6/10 patients have > 4 log reductions in HBsAg with loss occurring in 5 of these patients. Anti-HBs levels as high as 2422 mIU / mL accompany these HBsAg reductions.

Patients completing 24 weeks of peg-IFN + TDF have crossed over to triple combination therapy with NAPs after experiencing minimal HBsAg response. Crossover patients receiving either NAP are experiencing early, multiog reductions in HBsAg and increases in anti-HBs similar to the initial NAP responses seen in the experimental group. NAP-based triple combination therapy continues to be well tolerated in all patients with both NAPs.

This interim update from the REP 401 trial continues to demonstrate that NAPs have a unique and unsurpassed ability to safely clear serum HBsAg, substantially improving antiviral response to immunotherapy and allowing the achievement of functional control of both HBV and HDV infection.

Replicor’s presentation from APASL 2017 is available on the company’s website at www.replicor.com/science/conference-presentations. For further information about the 2017 APASL Meeting visit: http://www.apasl2017.org/#/.

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.

   

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才高八斗

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发表于 2017-2-20 22:40 |只看该作者
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Natacha Dorget
[email protected]
514-733-1998

Replicor在APASL 2017年公开了使用NAP组合治疗的高HBsAg损失率

蒙特利尔,2017年2月20日 - Replicor公司,一家私营的生物制药公司针对慢性乙型和丙型肝炎患者的治疗,提出了最新的临时分析,从最新REP 401临床试验在亚太肝脏研究协会APASL)于2017年2月15日至19日在中国上海举行。

REP 401方案(NCT02565719)是一项随机对照试验,评估其第一类核酸聚合物(NAP)HBsAg释放抑制剂REP 2139和REP 2165与替诺福韦酯延胡索酸酯(TDF)和聚乙二醇化干扰素的组合的安全性和有效性α-2a(peg-IFN)治疗慢性HBeAg阴性HBV感染的初始患者。

在接受与TDF和peg-IFN组合的NAP的患者中,接受REP 2139的8/9患者在其中7例中经历了HBsAg减少≥4log,HBsAg损失(HBsAg≤0.01IU/ ml)。对于REP 2165,具有改善的组织清除率的REP 2139变体,6/10患者具有HBlAg> 4log的减少,其中5个患者发生损失。这些HBsAg减少伴随着高达2422mIU / mL的抗HBs水平。

完成24周的peg-IFN + TDF的患者在经历最小的HBsAg反应后已经越过了与NAP的三联组合疗法。接受NAP的交叉患者正经历HBsAg的早期,多重减少和抗-HBs的增加,类似于实验组中观察到的初始NAP反应。基于NAP的三联组合疗法在所有NAP患者中继续被良好耐受。

来自REP 401试验的这一临时更新继续证明NAP具有独特和无与伦比的安全地清除血清HBsAg的能力,显着改善了对免疫治疗的抗病毒反应,并允许实现HBV和HDV感染的功能控制。

来自APASL 2017的复印机演示文稿可在公司网站www.replicor.com/science/conference-presentations上查阅。有关2017 APASL会议的更多信息,请访问:http://www.apasl2017.org/#/。

关于Replicor

Replicor是一家私人控股的生物制药公司,拥有最先进的动物和人类临床数据,可用于治疗HBV和HDV。该公司致力于加快对HBV和HBV / HDV共感染患者的有效治疗的发展。有关复制器的更多信息,请访问我们的网站www.replicor.com
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