JNJ-3989 EASL 报告

tim889

https://ir.arrowheadpharma.com/static-files/73b94014-ad50-4a49-b5fc-6f2ab391e6f4




如有后续对sustained和non-sustained responder 的免疫指标分析会很有意义。期待triple combo的结果

newchinabok

https://ir.arrowheadpharma.com/n ... -phase-2-clinical-0

齐欢畅

乙肝功能性治愈！单次皮下注射RNAi疗法AB-729显著

2020
06/18

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乙肝功能性治愈！单次皮下注射RNAi疗法AB-729显著
Arbutus Biopharma是一家临床阶段的生物制药公司，专注于开发治疗慢性乙型肝炎病毒（HBV）感染的药物。近日，该公司公布了一项Ia/Ib期临床试验（AB-729-001）的阳性随访数据。这些数据来自于单剂量60mgAB-729队列，该队列中正在接受背景核苷（酸）疗法治疗的慢性HBV患者接受了单次皮下注射60mg剂量AB-729。数据显示，60mg剂量单次皮下注射AB-729，显著、持久地降低了乙型肝炎表面抗原（HBsAg）水平。
AB-729是一种皮下注射RNAi疗法，靶向HBV复制和抑制抗原生成，包括乙型肝炎表面抗原（HBsAg）。在体外和体内的临床前模型中，AB-729均显示出强效、持久降低HBsAg水平。HBV蛋白的抑制，特别是HBsAg的抑制，被认为可以消除针对HBV的T细胞和B细胞活性的抑制，帮助恢复患者机体自身对HBV的免疫应答，从而为慢性HBV患者提供潜在的功能性治愈。
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这些数据使我们继续向实现目标前进：为慢性乙型肝炎患者提供一种可降低HBsAg水平的联合治疗方案。”
目前，市面上销售的乙肝药物只能抑制病毒复制，而不能清除病毒。基于RNA干扰（RNAi）和反义RNA技术的药物，能以高度特异性方式寻找、结合并破坏HBV RNA转录本、沉默所有HBV基因产物、阻止病毒蛋白产生，并在当前护理标准核苷酸和核苷类似物作用的逆转录过程上游进行干预。病毒蛋白的敲除，有望恢复机体天然免疫防御系统对HBV的免疫应答，清除病毒、实现功能性治愈。这类药物有望为乙肝治疗带来一场革命。
49551592446635607

HBV主要的治疗靶点
目前，有多家药企正在利用RNAi和反义RNA技术开发治疗慢性乙肝的药物，除了Arbutus公司（GalNAc-RNAi药物AB-729）之外，还包括强生/Arrowhead公司（JNJ-3989，前称ARO-HBV）、Ionis/葛兰素史克（反义RNA药物：IONIS-HBVRx，IONIS-HBV-LRx）、Vir/Alnylam（VIR-2218）、罗氏/Dicerna公司（DCR-HBVS）等。
说到这里，西医抗病毒治疗是很多患者的选择，目前治疗乙肝效果较好，低副作用，几乎不耐药的药物是韦立得，已经纳入医保了，患者可以到当地问询。当然也有患者看到了中医的显著疗法，尤其是在此次疫情期间，中医为疫情防疫做出的贡献不可磨灭，很多患者用西医抗病毒治疗配合中医疗法断毒，郑继红专家：多靶点中药复方治疗疗法可以帮助肝炎患者杀毒和抑制病毒，调理阴阳平衡和肝脏微循环功能，以达到修复炎症损害的肝细胞。具有安全系数高、见效快、疗效久等特点。
相信中西医结合会给各位患者朋友带来意想不到的效果，如发现身患乙肝肝炎请及时治疗就诊，祝大家身体健康阖家安康。

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Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data on Investigational Hepatitis B Therapeutic JNJ-3989 at The Digital Liver Congress
Aug 28, 2020 at 7:30 AM EDT
PASADENA, Calif. --(BUSINESS WIRE)--Aug. 28, 2020-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the presentation of Phase 2 clinical data from the AROHBV1001 phase 1/2 study on a double combination of JNJ-3989 (formerly ARO-HBV) and a nucleos(t)ide analog (NA) with collaborator
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PASADENA, Calif.--(BUSINESS WIRE)--Aug. 28, 2020-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the presentation of Phase 2 clinical data from the AROHBV1001 phase 1/2 study on a double combination of JNJ-3989 (formerly ARO-HBV) and a nucleos(t)ide analog (NA) with collaborator Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data are being presented in an oral presentation at The Digital International Liver Congress - The Annual Meeting of the European Association for the Study of the Liver (EASL).

JNJ-3989 is a liver-targeted investigational antiviral therapeutic for subcutaneous injection designed to treat chronic HBV (CHB) infection via the ribonucleic acid interference (RNAi) mechanism.

Janssen is currently conducting 48-week phase 2b studies of JNJ-3989 + NA, with or without JNJ-6379 to assess functional cure rates in patients with CHB. JNJ-6379 is an investigational orally administered capsid assembly modulator of the class that forms normal capsid structures (CAM-N). Arrowhead entered into a license and collaboration agreement with Janssen in October 2018 to develop and commercialize JNJ-3989.

Presentation Details:

Title: Short-term treatment with RNA interference therapy, JNJ-3989, results in sustained hepatitis B surface antigen suppression in patients with chronic hepatitis B receiving nucleos(t)ide analogue treatment
Authors: Edward Gane, et al.
Type: Oral Presentation
Date and Time: August 28, 2020 at 13:30 CEST
Key points presented include the following:

In the AROHBV1001 study in CHB patients, JNJ-3989 was administered on Days 0, 28, and 56 in combination with daily oral NA treatment
The objectives of this analysis were to assess sustained response in hepatitis B surface antigen (HBsAg), HBV RNA, hepatitis B e-antigen (HBeAg) and hepatitis B core-related antigen (HBcrAg) up to Day 392, 48 weeks after the last JNJ-3989 dose in patients with CHB continuing with NA treatment from Day 0 to end of study
Sustained responders were classified as those CHB patients with ≥1 log10 IU/mL reduction in HBsAg from Day 0 to Day 392
For the first time in patients with CHB, siRNA therapy resulted in sustained, off-treatment ≥1log10 IU/mL reductions in HBsAg through to 48 weeks in 39% of patients after the last JNJ-3989 dose
Reductions in HBV RNA, HBeAg, HBcrAg were seen across all cohorts, and were more pronounced in HBsAg sustained responders than non-responders
Three injections of JNJ-3989 administered once every 4 weeks were well tolerated at doses up to 400 mg and appeared to have a good long-term safety profile
These results support the evaluation of longer durations of treatment with JNJ-3989 + NA, with the objective of providing a functional cure in patients with CHB
A copy of the presentation materials may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

平凡之路123

杨梅这两年报废了四五款药，感觉元气大伤。

乙肝人1949

哎，说明，这个数学方程很难解，大佬也直挠头。

乙肝人1949

哎，说明，这个数学方程很难解，大佬也直挠头。