SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH)..

加利福尼亚州南旧金山，2024年4月3日（环球通讯社）--Aligos Therapeutics，Inc.（纳斯达克：ALGS，“Aligos”），一家临床阶段的生物制药公司，专注于开发新的治疗方法，以解决肝脏和病毒性疾病未得到满足的医疗需求，今天宣布，ALG-055009的2a期先驱研究已经开始在代谢功能障碍相关脂肪性肝炎（MASH）的受试者中使用。。

“Dosing the first subjects in our Phase 2a HERALD study is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We are pleased by the engagement of the clinicians and subjects, demonstrating the need for additional oral MASH therapies.

Aligos Therapeutics董事长、总裁兼首席执行官、MBA博士劳伦斯·布拉特（Lawrence Blatt）表示：“在我们的2a期先驱研究中，给第一批受试者服用药物是Aligos的一个重要里程碑。”。“我们很高兴临床医生和受试者的参与，表明需要额外的口服MASH疗法。

We look forward to continuing to advance this potent, potential best-in-class drug candidate through the clinic.”.

我们期待着通过诊所继续推进这种有效的，潜在的同类最佳候选药物。”。

HERALD (NCT06342947) is a randomized, placebo-controlled trial that will enroll ~100 subjects with presumed MASH and stage 1-3 liver fibrosis (F1-F3). Subjects will be randomized to receive one of four doses (0.3, 0.5, 0.7, 0.9 mg) of ALG-055009 or placebo (~20 subjects/arm) given orally once daily for 12 weeks.

HERALD（NCT06342947）是一项随机安慰剂对照试验，将招募约100名患有MASH和1-3期肝纤维化（F1-F3）的受试者。受试者将被随机分配接受四种剂量（0.3、0.5、0.7、0.9 mg）的ALG-055009或安慰剂（约20名受试者/组）中的一种，每天口服一次，持续12周。

In addition to collecting safety and pharmacokinetic (PK) data, this study will also assess multiple non-invasive biomarkers, which include Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) and other tests previously shown to be impacted by treatment with thyroid hormone receptor beta (THR-ß) agonists.

除了收集安全性和药代动力学（PK）数据外，本研究还将评估多种非侵入性生物标志物，包括磁共振成像质子密度脂肪分数（MRI-PDFF）和其他先前显示受甲状腺激素受体β（THR-ß）激动剂治疗影响的测试。

Topline safety and efficacy data from this study are expected in Q4 2024..

本研究的Topline安全性和有效性数据预计将于2024年第四季度发布。。

About ALG-055009

关于ALG-055009

ALG-055009 appears to be a best-in-class thyroid hormone receptor beta (THR-ß) agonist discovered by Aligos for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). ALG-055009 recently completed a Phase 1 first in human study, with preliminary data after single and multiple daily doses showing that ALG-055009 was well tolerated, had dose proportional pharmacokinetics (PK) and low variability, and demonstrated expected thyromimetic effects.

ALG-055009似乎是Aligos发现的用于治疗代谢功能障碍相关脂肪性肝炎（MASH）的最佳甲状腺激素受体β（THR-β）激动剂。ALG-055009最近完成了第一阶段人体研究，单次和多次每日剂量后的初步数据显示ALG-055009耐受性良好，具有剂量比例药代动力学（PK）和低变异性，并显示出预期的拟甲状腺作用。

Aligos has begun dosing in the Phase 2a HERALD study of ALG-055009 to assess safety, PK, and multiple efficacy biomarkers such as Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). Topline safety and efficacy data from this study are expected in Q4 2024..

Aligos已开始在ALG-055009的2a期先驱研究中给药，以评估安全性，PK和多种功效生物标志物，如磁共振成像质子密度脂肪分数（MRI-PDFF）。本研究的Topline安全性和有效性数据预计将于2024年第四季度发布。。

About MASH

关于MASH

One of the effects of improper diet and insufficient exercise is the accumulation of fatty deposits in the liver, referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), which was estimated to occur in approximately 30% of the worldwide population as of 2019. An estimated 1.5% to 6.5% of the global population is believed to have an ongoing inflammatory response to these excess fat deposits, which is referred to as metabolic dysfunction-associated steatohepatitis (MASH).

饮食不当和运动不足的影响之一是肝脏中脂肪沉积的积累，称为代谢功能障碍相关脂肪变性肝病（MASLD），据估计，截至2019年，全球约有30%的人口发生这种疾病。据估计，全球人口的1.5%至6.5%对这些过量脂肪沉积有持续的炎症反应，这被称为代谢功能障碍相关脂肪性肝炎（MASH）。

In the United States alone, the prevalence of MASH is projected to increase from approximately 16.5 million in 2015 to 27.0 million in 2030. In the absence of changes in diet and exercise, the inflammation inherent in MASH persists and may result in progressive fibrosis of the liver, which may result in cirrhosis.

仅在美国，MASH的流行率预计将从2015年的约1650万增加到2030年的2700万。在饮食和运动没有改变的情况下，MASH固有的炎症持续存在，并可能导致肝脏进行性纤维化，从而可能导致肝硬化。

These fibrotic changes are associated with numerous morbidities including recurrent hospitalization for complications of cirrhosis, hepatocellular carcinoma, need for liver transplant, and death. The first drug to treat this growing patient population, a THR-ß agonist, was recently approved..

这些纤维化变化与许多疾病有关，包括肝硬化并发症，肝细胞癌，肝移植需求和死亡的复发住院。最近批准了第一种治疗这一不断增长的患者群体的药物，一种苏氨酸激动剂。。

About Aligos

关于Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses..

Aligos Therapeutics，Inc.是一家临床阶段的生物制药公司，成立于2018年，其使命是成为肝脏和病毒性疾病治疗领域的世界领导者。Aligos的战略是利用其团队在肝脏和病毒性疾病方面的深厚专业知识和数十年的药物开发经验，发现并开发潜在的最佳治疗方法，用于代谢功能障碍相关脂肪性肝炎（MASH）和具有高度未满足医疗需求的病毒，如乙型肝炎和冠状病毒。。

Forward-Looking Statement

前瞻性声明

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, with respect to ALG-055009, the company looking forward to continuing to advance it through the clinic, it being a potential best-in-class THR-ß agonist drug candidate and the expectation of topline safety and efficacy data from the HERALD study in Q4 2024; and, with respect to MASH, the estimated occurrences of each of MASLD and MASH globally, the projected prevalence of MASH in the United States, and the possibility of cirrhosis resulting from the inflammation inherent in MASH in the absence of changes in diet and exercise.

本新闻稿包含1995年《美国私人证券诉讼改革法案》所指的前瞻性声明。本新闻稿中任何非历史事实的声明都可能被视为“前瞻性声明”，包括但不限于ALG-055009，该公司期待继续在临床上取得进展，它是一种潜在的同类最佳THR激动剂候选药物，以及对2024年第四季度HERALD研究的topline安全性和有效性数据的期望；关于MASH，全球MASLD和MASH的估计发生率，美国MASH的预计患病率，以及在饮食和运动没有变化的情况下MASH固有的炎症导致肝硬化的可能性。

Forward-looking statements are typically, but not always, identified by the use of words such as “may”, “will”, “would”, “believe”, “intend”, “plan”, “anticipate”, “estimate”, “expect”, and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements.

前瞻性陈述通常（但并非总是）通过使用诸如“可能”、“将”、“会”、“相信”、“打算”、“计划”、“预期”、“估计”、“预期”等词语以及其他类似的术语来表示未来的结果。此类前瞻性声明存在重大风险和不确定性，可能导致我们的发展计划、未来结果、绩效或成就与前瞻性声明中预期的存在重大差异。

Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficienc.

这些风险和不确定性包括但不限于药物开发过程中固有的风险和不确定性，包括Aligos的临床开发阶段，设计和进行临床试验的过程，监管审批流程，监管备案的时间安排，与制造药品相关的挑战，Aligos成功建立，保护和捍卫其知识产权的能力，以及其他可能影响足够的事项。

Contacts

联系人

Company

公司

Jordyn Tarazi

Jordyn Tarazi

Vice President, Investor Relations & Corporate Communications

投资者关系与企业传播副总裁

(650) 910-0427

(650) 910-0427

jtarazi@Aligos.com

jtarazi@Aligos.com

Media

媒体

Michael Fitzhugh

菲茨休

LifeSci Communications

LifeSci通信

mfitzhugh@lifescicomms.com

mfitzhugh@lifescicomms.com