SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced end-of-treatment data from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, with or without pegylated interferon alfa (PEG-IFNα), in participants with chronic hepatitis B.

旧金山--（商业新闻短讯）--Vir Biotechnology，Inc.（纳斯达克：Vir）今天宣布了3月2期临床研究B部分的治疗结束数据，该研究评估了tobevibart和elebsiran的组合，有或没有聚乙二醇化干扰素α（PEG-IFNα），用于慢性乙型肝炎患者。

The study demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens. The efficacy and safety profile support continued development to evaluate the potential to achieve a functional cure.

该研究表明，在两种联合治疗方案中，基线HBsAg较低（<1000 IU/mL）的参与者的乙型肝炎表面抗原（HBsAg）丢失率（血清清除率）很有希望。功效和安全性概况支持持续发展，以评估实现功能性治愈的潜力。

Detailed data will be presented in a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, in San Diego, CA, on November 18 at 5:00 p.m. PT. Vir Biotechnology will host an investor conference call on November 19, at 5.15 a.m. PT / 8.15 a.m.

详细数据将于11月18日下午5:00在加利福尼亚州圣地亚哥的美国肝病研究协会（AASLD）the Liver Meeting®（the Liver Meeting®）上进行最新的口头报告。Vir Biotechnology将于11月19日上午5:15/上午8:15主持投资者电话会议。

ET..

等。。

Chronic hepatitis B (CHB) is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV)1. The World Health Organization estimates that 254 million people live with CHB, and an estimated 1.1 million yearly deaths are associated with the disease2. Complications from CHB may include liver cirrhosis, liver failure and liver cancer3.

慢性乙型肝炎（CHB）是由乙型肝炎病毒（HBV）1引起的一种持久的炎症性肝病。世界卫生组织估计，有2.54亿人患有慢性乙型肝炎，估计每年有110万人死于这种疾病2。慢性乙型肝炎的并发症可能包括肝硬化，肝衰竭和肝癌3。

Although CHB can be treated, there is no cure1..

虽然CHB可以治疗，但没有治愈的方法。。

Participants in the trial received tobevibart and elebsiran alone (doublet regimen) or in combination with PEG-IFNα (triplet regimen). This analysis includes data from 51 participants in the doublet regimen arm and 27 participants in the triplet regimen arm at the end of treatment. Tobevibart was administered at 300 mg every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNα at 180 µg weekly.

试验参与者单独接受tobevibart和elebsiran（双重方案）或与PEG-IFNα（三联方案）联合使用。该分析包括在治疗结束时来自双重方案组的51名参与者和三联方案组的27名参与者的数据。；elebsiran，每4周200毫克；PEG-IFNα每周180µg。

Study primary endpoints include HBsAg seroclearance (defined as HBsAg below the lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10 mIU/mL) at end of treatment..

。次要终点包括治疗结束时抗-HBs血清转换（定义为抗-HBs≥10 mIU/mL的发展）。。

The doublet and triplet regimens resulted in HBsAg loss at the end of treatment in 39% (7/18) and 46% (5/11) of participants with baseline HBsAg<1,000 IU/mL, respectively. The proportion of participants with varying baseline HBsAg levels who achieved HBsAg loss at end of treatment was 16% (8/51) for the doublet and 22% (6/27) for the triplet regimen.

基线HBsAg<1000 IU/mL的参与者中，双重和三重方案分别有39%（7/18）和46%（5/11）在治疗结束时导致HBsAg丢失。基线HBsAg水平不同的参与者在治疗结束时达到HBsAg丢失的比例为双重治疗组为16%（8/51），三联治疗组为22%（6/27）。

The doublet regimen resulted in 50% (4/8) of participants who had achieved HBsAg loss also achieving anti-HBs seroconversion. All participants with HBsAg loss at the end of treatment who received the triplet regimen achieved anti-HBs seroconversion (100%, 6/6). Participants with HBsAg seroclearance at end of treatment who meet eligibility criteria will discontinue treatment.

双重方案导致50%（4/8）的HBsAg丢失的参与者也实现了抗-HBs血清转换。所有接受三联疗法治疗结束时HBsAg丢失的参与者均实现了抗HBs血清转换（100%，6/6）。治疗结束时HBsAg血清清除符合资格标准的参与者将停止治疗。

Functional cure assessment will occur 24 weeks after treatment discontinuation..

功能治愈评估将在停止治疗后24周进行。。

“People living with chronic hepatitis B must settle for life-long treatments that don’t eliminate the risk of disease progression to liver cancer,” said Edward J. Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital.

“慢性乙型肝炎患者必须接受终身治疗，但不能消除疾病发展为肝癌的风险，”新西兰奥克兰大学医学教授、奥克兰市医院首席肝病学家、移植医师兼新西兰肝移植科副主任爱德华·加内（EdwardJ.Gane）医学博士说。

“These latest data at end of treatment are encouraging as they suggest that tobevibart in combination with elebsiran could be key components for a hepatitis B functional cure. I look forward to the further results from this study anticipated next year.”.

“这些治疗结束时的最新数据令人鼓舞，因为它们表明托拜巴特联合elebsiran可能是乙型肝炎功能性治疗的关键组成部分。我期待着明年这项研究的进一步结果。”。

The safety and tolerability profile of tobevibart and elebsiran was consistent with prior studies, with no new safety concerns identified. TEAEs were generally mild or moderate.

tobevibart和elebsiran的安全性和耐受性概况与之前的研究一致，没有发现新的安全问题。TEAE通常是轻度或中度的。

“At Vir Biotechnology our ambition is to develop a functional cure for chronic hepatitis B following a finite treatment regimen. The MARCH data suggests that tobevibart and elebsiran can clear HBsAg and re-ignite the immune system, producing antibodies to potentially keep the virus under control,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology.

Vir Biotechnology执行副总裁兼首席医疗官Mark Eisner医学博士说：“Vir Biotechnology的目标是在有限的治疗方案后开发一种功能性治疗慢性乙型肝炎的方法。3月份的数据表明，tobevibart和elebsiran可以清除HBsAg并重新点燃免疫系统，产生抗体以潜在地控制病毒。”。

“We are encouraged by these results and eagerly anticipate the functional cure data in 2025, as it will be decisive for the next steps of clinical development.”.

“我们对这些结果感到鼓舞，并热切期待2025年的功能性治愈数据，因为它将对临床开发的下一步起决定性作用。”。

The data will be presented in the oral presentation Tobevibart (VIR-3434) and elebsiran (VIR-2218) with or without pegylated interferon alfa-2a for the treatment of chronic HBV infection: end of treatment results after 48 weeks of therapy (MARCH study) by Edward Gane, M.D., during a late breaking parallel session at AASLD The Liver Meeting® on November 18 at 5:00 pm PT..

这些数据将在有或没有聚乙二醇化干扰素α-2a治疗慢性HBV感染的Tobevibart（VIR-3434）和elebsiran（VIR-2218）的口头报告中提供：Edward Gane，M.D.在11月18日下午5:00在AASLD The Liver Meeting®的一次最新并行会议上，治疗48周后的治疗结束结果（三月研究）。。

Investor Conference Call

投资者电话会议

Vir Biotechnology will host an investor conference call on November 19, 2024 at 5:15 a.m. PT / 8:15 a.m. ET. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days.

https://investors.vir.bio/并将在www.vir.bio上存档30天。

About the Phase 2 MARCH Trial

关于3月2日的审判

MARCH is a Phase 2 study to evaluate the safety, tolerability, and efficacy of regimens containing tobevibart (VIR-3434), elebsiran (VIR-2218), alone or in combination with pegylated interferon alfa in patients with chronic hepatitis B. This Phase 2 study is a multi-center, open-label, non-randomized study.

。

Primary endpoints include HBsAg seroclearance (defined as HBsAg below lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment, as well as HBsAg loss at 24 weeks post-end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10mIU/mL) at end of treatment.

主要终点包括HBsAg血清清除率（定义为HBsAg低于定量下限）和治疗结束时的治疗紧急不良事件（TEAE），以及治疗结束后24周的HBsAg丢失。次要终点包括治疗结束时抗-HBs血清转化（定义为抗-HBs≥10mIU/mL的发展）。

Participants who achieve HBsAg seroclearance at end of treatment will discontinue treatment, and functional cure (evaluated as sustained off-treatment HBsAg loss) assessment will occur 24 weeks after treatment discontinuation. More information about this trial can be found at clinicaltrials.gov (NCT04856085)..

在治疗结束时达到HBsAg血清清除率的参与者将停止治疗，功能性治愈（评估为持续治疗后HBsAg丢失）评估将在治疗停止后24周进行。有关该试验的更多信息，请访问clinicaltrials.gov（NCT04856085）。。

About Tobevibart

关于Tobevibar

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform.

Tobevibart是一种针对乙型肝炎表面抗原的研究性广泛中和单克隆抗体。它旨在抑制乙型肝炎和三角洲肝炎病毒进入肝细胞，并降低血液中循环病毒和亚病毒颗粒的水平。Tobevibart结合了Xencor的Xtend™和其他Fc技术，已被设计为具有延长的半衰期，并使用Vir专有的单克隆抗体发现平台进行了鉴定。

Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta..

Tobevibart是皮下给药的，目前正在临床开发中用于治疗慢性乙型肝炎患者和慢性三角型肝炎患者。。

About Elebsiran

关于Elebsiran

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus.

Elebsiran是一种针对小干扰核糖核酸（siRNA）的研究性乙型肝炎病毒，旨在降解乙型肝炎病毒RNA转录本并限制乙型肝炎表面抗原的产生。目前的数据表明，它有可能对乙型肝炎病毒和三角洲肝炎病毒具有直接的抗病毒活性。

Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies..

Elebsiran是皮下给药的，目前正在临床开发中用于治疗慢性乙型肝炎患者和慢性三角洲肝炎患者。这是Vir与Alnylam Pharmaceuticals，Inc.合作进入临床研究的第一笔资产。。

About Vir Biotechnology, Inc.

关于Vir Biotechnology，Inc。

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to programs across several clinically validated targets in solid tumor indications.

Vir Biotechnology，Inc.是一家临床阶段的生物制药公司，专注于通过发现和开发治疗严重传染病和癌症的药物来增强免疫系统以改变生活。Vir的临床阶段组合包括针对慢性三角型肝炎和慢性乙型肝炎感染的传染病计划，以及针对实体瘤适应症的几个临床验证目标的计划。

Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website..

Vir还拥有一系列其他传染病和恶性肿瘤的临床前项目组合。Vir定期在其网站上发布对投资者可能很重要的信息。。

References:

参考文献：

1 CDC Hepatitis B Basics | Hepatitis B | CDC

1 CDC乙型肝炎基础知识|乙型肝炎| CDC

2 WHO Hepatitis B Factsheet - Hepatitis B (who.int), accessed September 2024

2世卫组织乙型肝炎概况-乙型肝炎（WHO.int），2024年9月查阅

3 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis B - NIDDK (nih.gov), accessed September 2024.

3 NIH国家糖尿病、消化和肾脏疾病研究所乙型肝炎NIDDK（NIH.gov），2024年9月访问。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。诸如“可能”、“将”、“计划”、“潜在”、“目标”、“期望”、“预期”、“有希望”等词语和类似表达（以及其他涉及未来事件、条件或情况的词语或表达）旨在识别前瞻性陈述。

These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization.

这些前瞻性声明基于截至本新闻稿发布之日，Vir的预期和假设。本新闻稿中包含的前瞻性声明包括但不限于以下方面的声明：Vir的战略和计划、托比巴特和elebsiran的潜在临床效果、托比巴特和elebsiran的潜在益处、安全性和有效性、Vir评估托比巴特和elebsiran的多项正在进行的试验数据的时间、性质和重要性、Vir对CHD和CHB计划的计划和期望以及与药物开发和商业化相关的风险和不确定性。

Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes.

许多因素可能会导致当前预期与实际结果之间的差异，包括意外的安全性或有效性数据或在临床试验或数据读数中观察到的结果；；意外成本、延误或其他意外障碍的风险；与其他公司合作困难；Vir的竞争对手成功开发和/或商业化替代产品候选产品；预期或现有竞争的变化；由于地缘政治变化或其他外部因素，Vir业务或临床试验延迟或中断；以及意外诉讼或其他纠纷。

Drug development and commercialization involve a high degree of risk, and only a small number .

药物开发和商业化涉及高度风险，只有少数风险。