SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection.

旧金山--（商业新闻短讯）--Vir Biotechnology，Inc.（纳斯达克：Vir）今天宣布，美国食品和药物管理局（FDA）已批准其研究性新药（IND）申请，并授予tobevibart和elebsiran联合治疗慢性三角洲肝炎感染的快速通道指定。

Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter..

Tobevibart是一种研究性单克隆抗体，elebsiran是一种研究性小干扰核糖核酸，目前正在该公司的2期至日肝炎三角洲临床试验中进行评估，完整的24周治疗数据将在第四季度报告。。

“The IND clearance and Fast Track designation from the FDA, along with the encouraging preliminary data from our Phase 2 hepatitis delta trial, underscore the potential of tobevibart and elebsiran to transform the treatment landscape for people living with this severe and life-threatening disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

Vir首席执行官、医学博士、工商管理硕士玛丽安·德巴克（MarianneDeBacker）说：“美国食品和药物管理局（FDA）的IND批准和快速通道指定，以及我们的2期肝炎三角洲试验的令人鼓舞的初步数据，突显了托拜巴特（tobevibart）和埃莱布西兰（elebsiran）改变这种严重威胁生命的疾病患者治疗格局的潜力。”。

“We are committed to working closely with health authorities to bring this potential groundbreaking treatment to patients as quickly as possible, addressing a critical unmet medical need.”.

“我们致力于与卫生部门密切合作，尽快为患者提供这种潜在的开创性治疗，解决严重的未满足医疗需求。”。

The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The World Health Organization considers hepatitis delta to be the most severe form of chronic viral hepatitis due to more rapid progression towards liver cancer and liver-related death.

FDA的快速通道指定旨在促进药物的开发和加速审查，以治疗严重疾病并满足未满足的医疗需求。世界卫生组织认为三角洲肝炎是最严重的慢性病毒性肝炎，因为肝癌和肝脏相关死亡的进展更快。

It is estimated that at least 12 million people are living with chronic hepatitis delta globally..

据估计，全球至少有1200万人患有慢性肝炎三角洲。。

In June, the Company announced preliminary Phase 2 SOLSTICE trial data which suggests treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization.

6月，该公司宣布了初步的2期SOLSTICE试验数据，该数据表明单独使用托比巴特或与elebsiran联合治疗通常耐受性良好，参与者在第12周和第24周达到了高病毒学应答率，持续病毒学应答持续48周，ALT正常化率高。

The complete 24-week treatment data is expected in the fourth quarter. The Company is working to expedite the initiation of its next study, the ECLIPSE trial. The open-label, randomized, controlled ECLIPSE trial is designed to support potential registration and will evaluate the safety and efficacy of a monthly-administered subcutaneous injection of tobevibart and elebsiran using the current standard of care therapy as a comparator..

预计第四季度将有完整的24周治疗数据。该公司正在努力加快启动下一项研究，即ECLIPSE试验。开放标签，随机，对照的ECLIPSE试验旨在支持潜在的注册，并将使用当前的护理标准疗法作为对照，评估每月皮下注射托拜巴特和elebsiran的安全性和有效性。。

About the Phase 2 SOLSTICE Trial

关于第二阶段至日审判

The SOLSTICE trial (NCT05461170) is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. One cohort is evaluating the combination of tobevibart and elebsiran dosed every 4 weeks with a second cohort evaluating tobevibart monotherapy every 2 weeks.

SOLSTICE试验（NCT05461170）正在评估tobevibart和elebsiran治疗慢性三角型肝炎患者的安全性，耐受性和有效性。一个队列正在评估每4周给药一次的tobevibart和elebsiran的组合，第二个队列每2周评估一次tobevibart单药治疗。

Approximately 50% of participants have compensated cirrhosis..

大约50%的参与者患有代偿性肝硬化。。

About Tobevibart (VIR-3434)

关于Tobevibart（VIR-343）

Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, and to reduce the level of virions 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是一种研究性皮下给药抗体，旨在抑制乙型肝炎和三角洲肝炎病毒进入肝细胞，中和乙型肝炎病毒和三角洲肝炎病毒粒子，并降低血液中病毒粒子和亚病毒粒子的水平。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。。

About Elebsiran (VIR-2218)

关于Elebsiran（VIR-218）

Elebsiran is an investigational subcutaneously administered 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. Vir believes it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus.

Elebsiran是一种研究性皮下注射乙型肝炎病毒，靶向小干扰核糖核酸（siRNA），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。Vir认为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。

It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc.

这是临床上第一个包括增强稳定化学加（ESC+）技术的siRNA，以增强稳定性并最大程度地降低脱靶活性，这可能导致治疗指数增加。Elebsiran是该公司与Alnylam Pharmaceuticals，Inc.合作的第一笔资产。

to enter clinical trials..

进入临床试验。。

About Vir Biotechnology, Inc.

关于Vir Biotechnology，Inc。

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes.

Vir Biotechnology，Inc.是一家免疫学公司，专注于通过治疗和预防传染病和其他严重疾病（包括病毒相关疾病），为免疫系统提供动力，以改变生活。Vir已经组装了两个技术平台，旨在通过利用对自然免疫过程的关键观察来调节免疫系统。

Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses, and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts information that may be important to investors on its website..

其目前的临床开发流程包括针对三角洲肝炎病毒和乙型肝炎病毒以及人类免疫缺陷病毒的候选产品。Vir有几个临床前候选药物，包括针对甲型和乙型流感，新型冠状病毒，RSV/MPV和HPV的候选药物。Vir定期在其网站上发布对投资者可能很重要的信息。。