DURHAM, N.C.--(BUSINESS WIRE)--Apr. 15, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS

达勒姆，北卡罗来纳州--（商业资讯）--2025年4月15日，Precision BioSciences公司（纳斯达克股票代码：DTIL），一家处于临床阶段的基因编辑公司，利用其新型专有的ARCUS技术平台。

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platform to develop

开发平台

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gene editing therapies for diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PBGENE-HBV, the Company’s lead wholly owned

针对高未满足需求疾病的基因编辑疗法，今日宣布美国食品药品监督管理局（FDA）已授予PBGENE-HBV快速通道资格，这是公司领先的全资拥有产品。

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vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes.

旨在通过消除cccDNA（乙肝病毒复制的关键来源）和灭活肝细胞中整合的HBV DNA，来治愈慢性乙型肝炎的基因编辑项目。

“We are pleased to receive Fast Track designation from the FDA for PBGENE-HBV and believe this classification underscores the urgent need for improved treatment options for patients living with chronic hepatitis B,” said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences.

“我们很高兴PBGENE-HBV获得FDA的快速通道资格，相信这一分类凸显了慢性乙型肝炎患者对改进治疗方案的迫切需求，”Precision BioSciences总裁兼首席执行官Michael Amoroso表示。

“We’ve been encouraged by the initial safety and antiviral activity we have observed in the ELIMINATE-B trial and look forward to continuing to work closely with the FDA as we progress PBGENE-HBV through clinical development.”.

“我们在ELIMINATE-B试验中观察到的初步安全性和抗病毒活性备受鼓舞，并期待随着PBGENE-HBV在临床开发中的进展，继续与FDA密切合作。”

Precision is evaluating PBGENE-HBV in the ongoing global Phase 1 ELIMINATE-B trial, with clinical investigation in the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom. The company anticipates sharing updates on the full low-dose cohort, including multiple dose administrations, and data from higher dose levels throughout 2025..

Precision正在正在进行的全球1期ELIMINATE-B试验中评估PBGENE-HBV，在美国、摩尔多瓦、香港、新西兰和英国进行临床研究。该公司预计将在2025年全年分享完整的低剂量队列的更新信息，包括多次给药，以及来自更高剂量水平的数据。

Fast Track designation is designed to facilitate development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and address an unmet medical need. A drug that has received Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

快速通道资格旨在促进用于治疗严重或危及生命的情况并满足未满足医疗需求的药物的开发，并加快对其的审查。获得快速通道资格的药物可能有资格与 FDA 进行更频繁的会议和沟通，并对任何上市申请进行滚动审查。

A drug receiving Fast Track designation may also be eligible for Priority Review if relevant criteria are met..

获得快速通道指定的药物如果符合相关标准，也可能有资格进行优先审查。

About PBGENE-HBV (Viral Elimination Program):

关于PBGENE-HBV（病毒清除计划）：

PBGENE-HBV is Precision’s wholly owned

PBGENE-HBV是Precision公司全资拥有的

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gene editing program under investigation in a global first-in-human clinical trial, which is designed to potentially cure chronic hepatitis B infection. Currently, it is estimated that 300 million people worldwide are afflicted with chronic hepatitis B. PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA.

基因编辑项目正在全球首个首次人体临床试验中进行研究，该试验旨在可能治愈慢性乙型肝炎感染。据目前估计，全球有3亿人患有慢性乙型肝炎。PBGENE-HBV 是第一个也是唯一一个进入临床研究的潜在治愈性基因编辑项目，专门设计用于消除cccDNA并使整合的HBV DNA失活。

Lipid nanoparticle technology for PBGENE-HBV has been provided by Acuitas Therapeutics Inc..

PBGENE-HBV的脂质纳米颗粒技术由Acuitas Therapeutics Inc.提供。

About Hepatitis B:

关于乙型肝炎：

Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. Despite the availability of approved antiviral therapies, an estimated 300 million people globally and 1-2 million people in the US are estimated to have chronic hepatitis B infection.

乙型肝炎是美国发病率的主要原因之一，也是全球死亡的主要原因之一，目前尚无治愈方法可供患者使用。尽管已有获批的抗病毒疗法，但据估计，全球约有 3 亿人，美国约有 100 万到 200 万人患有慢性乙型肝炎感染。

An estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver failure, or liver cancer (hepatocellular carcinoma), which account for the majority of HBV-related deaths..

据估计，15% 至 40% 的乙型肝炎病毒感染患者可能会出现并发症，如肝硬化、肝衰竭或肝癌（肝细胞癌），这些并发症占乙型肝炎相关死亡的大多数。

Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA and integration of HBV DNA into the human genome in liver cells, the primary source of hepatitis B surface antigen (HBsAg) in late-stage disease. Current treatments for patients with HBV infection include agents that result in long-term viral suppression as indicated by reduction of circulating HBV DNA, but these therapies do not eradicate HBV cccDNA, rarely lead to functional cure, and require lifelong administration..

慢性乙型肝炎感染主要由HBV cccDNA的持续存在以及HBV DNA整合到肝细胞的人类基因组中驱动，这是晚期疾病中乙型肝炎表面抗原（HBsAg）的主要来源。目前针对HBV感染患者的治疗方法包括通过减少循环HBV DNA来实现长期病毒抑制的药物，但这些疗法无法根除HBV cccDNA，很少能实现功能性治愈，并且需要终身用药。

About Precision BioSciences, Inc.

关于Precision BioSciences公司

Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS

Precision BioSciences, Inc. 是一家临床阶段的基因编辑公司，致力于通过其新颖且专有的 ARCUS 改善生活 (DTIL)。

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genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of .

基因组编辑平台，它通过切割方式、更小的尺寸和更简单的结构区别于其他技术。关键能力和差异化特征可能使ARCUS核酸酶能够推动更多预期的、明确的治疗结果。利用ARCUS，公司的产品线由...组成。

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gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.

旨在为最广泛的遗传性和传染性疾病提供持久治愈方案的基因编辑候选药物，而这些疾病目前尚无足够的治疗方法。有关 Precision BioSciences 的更多信息，请访问 www.precisionbiosciences.com。

The ARCUS

弧线

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platform is being used to develop

平台正在被用于开发

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gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV)..

基因编辑疗法用于复杂的基因编辑，包括基因插入（将DNA插入基因以引起表达/添加功能）、消除（移除基因组，例如病毒DNA或突变的线粒体DNA）和切除（通过单个AAV递送两个ARCUS核酸酶去除大部分缺陷基因）。

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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of PBGENE-HBV and our gene editing approaches including editing efficiency, and the suitability of ARCUS nucleases for gene insertion, gene elimination and gene excision and differentiation from other gene editing approaches; the expected timing of regulatory processes and clinical operations, including filings, studies, enrollment and clinical data for PBGENE-HBV; the design of PBGENE-HBV to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures; the encouraging initial safety and antiviral activity observed in the ELIMINATE-B clinical trial; plans to provide ongoing updates on the full low-dose cohort for the PBGENE-HBV study, including multiple dose administrations, and data from higher dose levels throughout 2025; and anticipated timing of clinical data .

本新闻稿包含1995年《私人证券诉讼改革法案》意义上的前瞻性声明。本新闻稿中所有不涉及历史事实的声明均应被视为前瞻性声明，包括但不限于关于PBGENE-HBV的临床开发及其预期安全性、有效性与益处的声明，以及我们基因编辑方法的相关声明，包括编辑效率，和ARCUS核酸酶在基因插入、基因消除和基因切除中的适用性及其与其他基因编辑方法的差异；监管流程和临床操作的预期时间安排，包括PBGENE-HBV的申报、研究、入组和临床数据；PBGENE-HBV旨在直接消除cccDNA并以高特异性灭活整合的HBV DNA，可能实现功能性治愈的设计；ELIMINATE-B临床试验中观察到的初步安全性和抗病毒活性的良好表现；计划持续更新PBGENE-HBV研究中完整低剂量队列的数据，包括多次给药，并在2025年全年提供更高剂量水平的数据；以及临床数据的预期时间安排。

In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “appear,” “approach,” “believe,” “contemplate,” “could,” “designed,” “encouraged”, “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions..

在某些情况下，您可以通过诸如“目标”、“预期”、“显现”、“接近”、“相信”、“考虑”、“可能”、“设计”、“鼓励”、“估计”、“预计”、“目的”、“打算”、“展望”、“或许”、“使命”、“计划”、“可能”、“潜力”、“预测”、“项目”、“追求”、“应该”、“努力”、“建议”、“针对”、“将”、“会”或其否定形式以及类似词汇和表达来识别前瞻性陈述。

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liabi.

前瞻性声明基于管理层的当前预期、信念和假设，以及我们目前可获得的信息。这些声明既不是承诺也不是保证，涉及许多已知和未知的风险、不确定性和假设，实际结果可能因各种重要因素而与前瞻性声明中表达或暗示的结果有重大差异，这些因素包括但不限于：我们实现盈利的能力；我们获取足够资金以推进项目的能力；与我们的资本需求、预期现金跑道、现有债务工具下的要求及限制相关风险，包括因市场状况和/或我们的市值导致的额外融资能力；我们的运营费用及我们预测这些费用的能力；我们有限的运营历史；我们在其中投入资源的项目和候选产品的进展与成功；我们评估候选产品安全性和有效性的有限能力或无能力；其他基因编辑技术可能较我们的ARCUS技术提供显著优势的风险；我们对ARCUS技术的依赖；研究和开发活动及临床前和临床研究（包括临床试验和新药研究申请）的启动、成本、时间安排、进展、里程碑达成和结果；公众对基因编辑技术及其应用的看法；在基因编辑、生物制药和生物技术领域的竞争；我们或我们的合作伙伴或其他被许可方识别、开发和商业化候选产品的能力；现有的和潜在的产品责任。

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise..

本新闻稿中的所有前瞻性声明仅截至本新闻稿发布之日，除非适用法律要求，我们没有义务更新或修改本文中包含的任何前瞻性声明，无论是否因新信息、未来事件、情况变化或其他原因。

Source: Precision BioSciences, Inc.

来源：Precision BioSciences, Inc.

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