—With the initiation of ENLIGHTEN-Cirrhosis, pegozafermin is the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis (F4)—

-随着启蒙肝硬化的开始，pegozafermin是第一个进入代偿性肝硬化（F4）MASH患者3期试验的FGF21类似物-

—Regression of fibrosis by histology at month 24 will serve as the basis for potential accelerated approval with clinical outcomes to support the potential for confirmatory or full approval—

-在第24个月通过组织学对纤维化的消退将作为潜在加速批准的基础，并具有临床结果，以支持确认或完全批准的潜力-

SAN FRANCISCO, May 14, 2024 (GLOBE NEWSWIRE) --89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENLIGHTEN-Cirrhosis, a Phase 3 trial of pegozafermin in patients with MASH with compensated cirrhosis (F4)..

旧金山，2024年5月14日（环球通讯社）--89bio，Inc.（纳斯达克：ETNB），一家临床阶段的生物制药公司，专注于开发和商业化用于治疗肝脏和心脏代谢疾病的创新疗法，今天宣布启动启蒙肝硬化，这是培戈沙芬治疗代偿性肝硬化（F4）MASH患者的3期临床试验。。

“MASH patients with compensated cirrhosis are in critical need of effective therapies that can halt and ideally reverse the progression of fibrosis to prevent the onset of liver decompensation,” said Arun J. Sanyal, MBBS, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University.

弗吉尼亚联邦大学斯特拉维茨·桑亚尔肝病与代谢健康研究所主任、医学博士阿伦·J·桑亚尔（ArunJ.Sanyal）说：“患有代偿性肝硬化的MASH患者迫切需要有效的治疗方法，可以阻止并理想地逆转纤维化的进展，以防止肝失代偿的发生。”。

“Due to its demonstrated anti-fibrotic benefits, pegozafermin has the potential to be uniquely positioned to meet the needs of compensated cirrhotic MASH patients and could reduce the risk of decompensation. I look forward to evaluating the potential benefits of pegozafermin in this Phase 3 trial given the severity of symptoms this patient population experiences.”.

“由于其显示出抗纤维化的益处，pegozafermin有可能被独特定位以满足代偿性肝硬化MASH患者的需求，并可以降低失代偿的风险。鉴于该患者群体症状的严重程度，我期待在这项3期试验中评估pegozafermin的潜在益处。”。

ENLIGHTEN-Cirrhosis is a global Phase 3, randomized, double-blind, placebo-controlled trial evaluating pegozafermin for the treatment of MASH patients with compensated cirrhosis (F4). The trial will enroll approximately 760 patients, who will be randomized in a 1:1 ratio to either receive 30mg of pegozafermin administered weekly or a placebo.

启蒙肝硬化是一项全球性的3期随机双盲安慰剂对照试验，评估培戈沙芬治疗代偿性肝硬化（F4）MASH患者。该试验将招募大约760名患者，他们将以1:1的比例随机接受每周服用30mg培戈沙芬或安慰剂。

The interim analysis primary endpoint of fibrosis regression is defined as improvement in fibrosis from F4 to an earlier stage. A subset of the 760 patients will be evaluated at 24 months to assess fibrosis regression, potentially supporting an accelerated approval filing in the United States and conditional approval in Europe.

中期分析纤维化消退的主要终点定义为从F4到早期阶段纤维化的改善。760名患者中的一部分将在24个月时进行评估，以评估纤维化消退，这可能支持在美国加速批准申请和在欧洲有条件批准。

The trial will continue to monitor all participants until a pre-defined number of clinical outcome events are observed. The primary endpoint for the final analysis will be a clinical outcome composite and is expected to form the basis for confirmatory or full approval for MASH patients at both stage F4 and as well as stages F2-F3.

该试验将继续监测所有参与者，直到观察到预定义数量的临床结果事件。最终分析的主要终点将是临床结果综合，预计将为F4期和F2-F3期MASH患者的确认或完全批准奠定基础。

Based on prior discussions and alignment with regulatory agencies on the modified definitions of cirrhosis clinical outcome events, the timeline for reaching the expected number of events could be expedited compared to previous Phase 3 trials that have been conducted in MASH patients with compensated cirrhosis..

根据之前的讨论以及与监管机构就肝硬化临床结局事件的修改定义的一致性，与之前在代偿性肝硬化MASH患者中进行的3期试验相比，可以加快达到预期事件数量的时间表。。

“Initiating the ENLIGHTEN-Cirrhosis trial marks a significant milestone for pegozafermin as it becomes the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis,” said Hank Mansbach, Chief Medical Officer of 89bio. “Regulatory agencies have aligned on a potential accelerated approval pathway based on histological evidence showing regression of fibrosis.

89bio首席医疗官汉克·曼巴赫（Hank Mansbach）表示：“启动INDIGHT肝硬化试验标志着培戈沙芬成为首个进入代偿性肝硬化MASH患者3期试验的FGF21类似物，标志着培戈沙芬的一个重要里程碑。监管机构已经根据组织学证据显示纤维化消退的潜在加速批准途径达成一致。

In our Phase 2b ENLIVEN trial, we observed not only improvements in key non-invasive markers of liver inflammation and fibrosis, but specific improvements in fibrosis based on histology among patients treated with pegozafermin. We are eager to build on these results in our comprehensive global Phase 3 trial involving a larger number of patients.”.

在我们的2b期ENVIVEN试验中，我们不仅观察到肝脏炎症和纤维化的关键非侵入性标志物的改善，而且还观察到了基于组织学的pegozafermin治疗患者纤维化的特异性改善。我们渴望在涉及更多患者的综合性全球3期临床试验中，以这些结果为基础。”。

Key secondary endpoints include noninvasive tests (NITs) evaluating liver health and metabolic markers. The trial is designed to employ a three-panel consensus biopsy reading methodology, which was successfully utilized in the Phase 2b ENLIVEN trial. Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection..

关键的次要终点包括评估肝脏健康和代谢标志物的无创检测（NIT）。该试验旨在采用三组共识活检阅读方法，该方法已成功用于2b期ENLIVEN试验。患者将使用计划的商业液体制剂（单次皮下注射）自行服用培戈沙芬。。

About metabolic dysfunction-associated steatohepatitis (MASH)

关于代谢功能障碍相关的脂肪性肝炎（MASH）

MASH, also known as nonalcoholic steatohepatitis (NASH), is a chronic and progressive condition that represents a severe form of metabolic dysfunction-associated steatotic liver disease (MASLD). It is characterized by fat accumulation in the liver, which causes inflammation and can ultimately lead to scarring or fibrosis.

MASH，也称为非酒精性脂肪性肝炎（NASH），是一种慢性进行性疾病，代表了一种严重的代谢功能障碍相关的脂肪变性肝病（MASLD）。它的特征是肝脏中的脂肪堆积，这会引起炎症，并最终导致疤痕或纤维化。

By 2030, it is projected to affect over 27 million people in the U.S. The disease is categorized based on the extent of liver fibrosis. In cases of advanced fibrosis, the treatment goal is to improve liver health, reverse fibrosis, and prevent the progression of the disease and related complications such as cirrhosis and cardiovascular risks.

到2030年，预计将影响美国2700多万人。该疾病根据肝纤维化程度进行分类。在晚期纤维化的情况下，治疗目标是改善肝脏健康，逆转纤维化，预防疾病进展和相关并发症，如肝硬化和心血管风险。

Estimates suggest that approximately 20% of patients with MASH may develop cirrhosis, a serious condition that significantly impairs liver function. Cirrhosis can lead to life-threatening complications from esophageal varices, ascites, or hepatocellular carcinoma. Patients may ultimately require a liver transplant to avoid death from liver failure..

估计表明，大约20%的MASH患者可能会发展为肝硬化，这是一种严重损害肝功能的严重疾病。肝硬化可导致食管静脉曲张、腹水或肝细胞癌等危及生命的并发症。患者可能最终需要进行肝移植以避免因肝衰竭而死亡。。

About the ENLIGHTEN Program

关于启蒙计划

The ENLIGHTEN program is comprised of two Phase 3 global, multi-center, randomized, double-blind, placebo-controlled trials, evaluating the efficacy and safety of pegozafermin in patients with MASH. The ENLIGHTEN-Fibrosis trial, the first of two Phase 3 trials in the program, will enroll approximately 1,000 patients with non-cirrhotic MASH (fibrosis stage F2-F3) to evaluate the efficacy and safety of pegozafermin.

启蒙计划由两项三期全球，多中心，随机，双盲，安慰剂对照试验组成，评估培戈沙芬在MASH患者中的疗效和安全性。启蒙纤维化试验是该计划中两项3期试验的第一项，将招募约1000名非肝硬化MASH（纤维化阶段F2-F3）患者，以评估培戈沙芬的疗效和安全性。

The co-primary endpoints, for which demonstration of an effect on each is needed to support regulatory approval, measured at week 52 are a one-point improvement in fibrosis with no worsening of MASH and MASH resolution with no worsening of fibrosis, assessed at week 52. ENLIGHTEN-Cirrhosis, the second of two Phase 3 trials in the program, will evaluate the efficacy and safety of pegozafermin in MASH patients with compensated cirrhosis (F4)..

在第52周测量的共同主要终点，需要证明对每个终点的影响以支持监管批准，是纤维化的一点改善，没有恶化的MASH和MASH分辨率，没有恶化的纤维化，在第52周评估。启蒙肝硬化是该项目两个3期试验中的第二个，将评估培戈沙芬治疗代偿性肝硬化（F4）MASH患者的疗效和安全性。。

About Pegozafermin

关于Pegozafermin

Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that has broad effects such as regulating energy expenditure, glucose and lipid metabolism.

Pegozafermin是一种专门设计的成纤维细胞生长因子21（FGF21）糖聚乙二醇化类似物，用于治疗代谢功能障碍相关的脂肪性肝炎（MASH）和严重的高甘油三酯血症（SHTG）。FGF21是一种内源性激素，具有广泛的作用，例如调节能量消耗，葡萄糖和脂质代谢。

In clinical trials, pegozafermin has demonstrated direct anti-fibrotic and anti-inflammatory effects on the liver, as well as reduced triglyceride levels, improved insulin resistance and glycemic control, and continued to demonstrate a favorable safety and tolerability profile. Pegozafermin received Breakthrough Therapy designation (BTD) status from the U.S.

在临床试验中，pegozafermin已显示出对肝脏的直接抗纤维化和抗炎作用，以及降低甘油三酯水平，改善胰岛素抵抗和血糖控制，并继续表现出良好的安全性和耐受性。Pegozafermin从美国获得突破性治疗指定（BTD）状态。

Food and Drug Administration (FDA) and Priority Medicines (PRIME) status from the European Medicines Agenda (EMA) for the treatment of MASH with fibrosis. Pegozafermin is being studied in the Phase 3 ENLIGHTEN trial program for MASH and is being studied in the Phase 3 ENTRUST trial for SHTG..

食品和药物管理局（FDA）和欧洲药物议程（EMA）的优先药物（PRIME）状态，用于治疗纤维化的醪液。Pegozafermin正在MASH的第三阶段启蒙试验计划中进行研究，并且正在SHTG的第三阶段委托试验中进行研究。。

About 89bio

关于89bio

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).

89bio是一家临床阶段的生物制药公司，致力于为缺乏最佳治疗选择的肝脏和心脏代谢疾病患者开发一流的治疗方法。该公司专注于通过临床开发快速推进其主要候选药物pegozafermin，用于治疗代谢功能障碍相关脂肪性肝炎（MASH）和严重高甘油三酯血症（SHTG）。

Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn..

Pegozafermin是一种专门设计的，可能是同类最佳的成纤维细胞生长因子21（FGF21）类似物，具有独特的糖聚乙二醇化技术，可通过延长半衰期来优化生物活性。公司总部设在旧金山。欲了解更多信息，请访问www.89bio.com或在LinkedIn上关注该公司。。

Forward-Looking Statements

前瞻性声明

Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the anticipated design of and enrollment in the ENLIGHTEN-Cirrhosis trial and the possibility of obtaining accelerated approval in the United States and conditional approval in Europe in compensated cirrhosis (F4) MASH patients using regression of fibrosis by histology at month 24 in ENLIGHTEN-Cirrhosis trial.

本新闻稿中的某些声明可能构成《联邦证券法》所指的“前瞻性声明”，包括但不限于关于培戈沙芬的治疗潜力和效用、疗效和临床益处、培戈沙芬的安全性和耐受性概况、试验设计、培戈沙芬的临床开发计划和时间安排的声明，包括预期的设计和参加“启蒙肝硬化试验”的可能性，以及在美国获得加速批准和在欧洲获得有条件批准的代偿性肝硬化（F4）MASH患者在“启蒙肝硬化试验”第24个月通过组织学消退纤维化的可能性。

Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'anticipate,' 'goal,' 'opportunity,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements.

诸如“可能”，“可能”，“意志”，“目标”，“打算”，“应该”，“可能”，“可以”，“会”，“期望”，“相信”，“设计”，“估计”，“预测”，“潜力”，“预期”，“目标”，“机会”，“发展”，“计划”或这些术语的负面影响，以及类似的表达或关于意图，信念或当前期望的陈述，都是前瞻性陈述。

While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio's control and subject to change.

虽然89bio认为这些前瞻性声明是合理的，但不应过度依赖任何此类前瞻性声明，这些声明是基于我们在本发布之日获得的信息。这些前瞻性陈述基于当前的估计和假设，并受到各种风险和不确定性的影响（包括但不限于89bio向美国证券交易委员会（SEC）提交的文件中规定的风险和不确定性），其中许多风险和不确定性超出了89bio的控制范围，可能会发生变化。

Actual results could be materially different. Risks and uncertainties include: expectations regarding the design of the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials.

实际结果可能会有很大不同。风险和不确定性包括：对启蒙纤维化和启蒙肝硬化试验设计的期望。

Investor Contact:

投资者联系人：

Annie Chang

张安妮

89bio, Inc.

89bio公司。

investors@89bio.com

investors@89bio.com

PJ Kelleher

PJ Kelleher

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

+1-617-430-7579

+1-617-430-7579

pkelleher@lifesciadvisors.com

pkelleher@lifesciadvisors.com

Media Contact:

媒体联系人：

Sheryl Seapy

谢丽尔·西皮。

Real Chemistry

真正的化学

sseapy@realchemistry.com

sseapy@realchemistry.com