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Aligos Therapeutics Presents Positive Clinical Data at APASL 2024 From ALG-055009 and ALG-000184 Phase 1 Studies

Aligos Therapeutics Presents Positive Clinical Data at APASL 2024 From ALG-055009 and ALG-000184 Phase 1 Studies

Aligos Therapeutics 在 2024 年 APASL 上公布了来自 ALG-055009 和 ALG-000184 1 期研究的积极临床数据
GlobeNewswire ·  03/27 20:00

SOUTH SAN FRANCISCO, Calif., March 27, 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 three oral presentations and one poster presentation at the 33rd Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2024, being held March 27-31, 2024 in Kyoto, Japan.

加利福尼亚州南旧金山,2024年3月27日(GLOBE NEWSWIRE)——专注于开发新疗法以满足肝脏和病毒性疾病未得到满足的医疗需求的临床阶段生物制药公司Aligos Therapeutics, Inc.(纳斯达克股票代码:ALGS,“Aligos”)今天在33日宣布了三场口头演讲和一次海报演讲第三方 2024年亚太肝脏研究协会(APASL)年会将于2024年3月27日至31日在日本京都举行。

The poster presentation highlights ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liver.

海报展示重点介绍了 ALG-055009 1 期数据,该数据显示,高脂血症受试者在 14 天内的多次递增剂量 (MAD) 对动脉粥样硬化脂质和性激素结合球蛋白 (SHBG) 产生了良好的剂量依赖性药效学作用,性激素结合球蛋白 (SHBG) 是靶向参与肝脏的指标。

The three oral presentations provide interim data from Parts 3 and 4 of Aligos' ALG-000184 Phase 1 extended dosing study showing consistent, potent antiviral activity across different cohorts of untreated CHB patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV).

这三份口头陈述提供了来自Aligos的 ALG-000184 1期延长剂量研究的第三部分和第四部分的中期数据,这些数据显示,在作为单一疗法或与恩替卡韦(ETV)联合使用的 ALG-000184 的不同群体的未经治疗的 CHB 患者中,具有一致而有效的抗病毒活性。

"We are pleased to present these additional Phase 1 data for ALG-055009 and ALG-000184 at APASL 2024. After the recent initiation of our Phase 2a HERALD study of ALG-055009 in MASH subjects, we remain encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement, as shown by induction of sex hormone binding globulin and lowering of atherogenic lipids. We continue to believe our molecule has the potential to be best-in-class," said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. "In addition, the three ALG-000184 oral presentations demonstrate a consistent effect in the reduction of key viral markers. These promising results affirm our belief that this compound will play an essential role in the future treatment of hepatitis B."

“我们很高兴在 APASL 2024 上提供 ALG-055009 和 ALG-000184 的额外第一阶段数据。在我们最近启动了针对 MASH 受试者的 ALG-055009 的 2a 期 HERALD 研究之后,我们仍然对所提供的数据感到鼓舞,这些数据显示出良好的安全性和有力的靶向参与证据,如诱导性激素结合球蛋白和降低动脉粥样硬化脂质所示。我们仍然相信我们的分子有可能成为同类最佳分子。” 博士、工商管理硕士、Aligos Therapeutics董事长、总裁兼首席执行官劳伦斯·布拉特说。“此外,三次 ALG-000184 口头陈述在减少关键病毒标志物方面表现出一致的效果。这些令人鼓舞的结果证实了我们的信念,即这种化合物将在未来的乙型肝炎治疗中发挥至关重要的作用。”

Details of the presentations are as follows:

演讲详情如下:

ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

ALG-055009:潜在的同类最佳小分子 THR-β 激动剂,用于代谢功能障碍相关性脂肪肝炎 (MASH)

  • Poster Presentation Title: Pharmacodynamics of Multiple Ascending Oral Doses of ALG-055009, a THR-β Agonist, in Hyperlipidemic Subjects
    • Presented by Megan Fitzgerald, Ph.D.
    • March 28, 2024 at 5:10pm GMT+9
  • 海报演示文稿标题: 高脂血症受试者多次递增口服剂量 ALG-055009(一种 THR-β 激动剂)的药效学
    • 由梅根·菲茨杰拉德博士主持
    • 格林威治标准时间+9 2024 年 3 月 28 日下午 5:10

ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB)

ALG-000184:治疗慢性乙型肝炎(CHB)的潜在同类最佳小分子 CAM-E

  • Oral Presentation Title: ALG-000184 (300mg) ± Entecavir Results in Substantial HBV Antigen Declines in Untreated HBeAg-Positive Subjects with CHB
    • Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
    • March 28, 2024 at 9:30am GMT+9
  • Oral Presentation Title: ALG-000184 (100 mg) + ETV Leads to Stronger Antiviral Effects Compared to ETV Alone in HBeAg-Positive CHB
    • Presented by Professor Jinlin Hou, MD, Director and Professor of the Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
    • March 28, 2024 at 9:48am GMT+9
  • Oral Presentation Title: ALG-000184 Has Favorable Antiviral Effect & Safety in Untreated Asian/Non-Asian HBeAg-Negative CHB Subjects
    • Presented by Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
    • March 28, 2024 at 9:57am GMT+9
  • 口头陈述标题: ALG-000184 (300mg) ± 恩替卡韦导致未经治疗 HBeAg 阳性的 CHB 受试者的 HBV 抗原显著下降
    • 由香港大学胃肠病学和肝病学系主任袁万丰教授,医学博士,博士,博士学位主讲
    • 格林威治标准时间+9 2024 年 3 月 28 日上午 9:30
  • 口头陈述标题: ALG-000184(100 mg)+ ETV 与 HBeAG 阳性 CHB 中单独使用 ETV 相比,具有更强的抗病毒作用
    • 由南方医科大学南方医院肝病科和传染病科主任兼教授侯金林教授主讲
    • 格林威治标准时间+9 2024 年 3 月 28 日上午 9:48
  • 口头陈述标题: ALG-000184 对未经治疗的亚洲/非亚洲 HBeAg 阴性 CHB 受试者具有良好的抗病毒作用和安全性
    • 由香港大学胃肠病学和肝病学系主任袁万丰教授,医学博士,博士,博士学位主讲
    • 格林威治标准时间+9 2024 年 3 月 28 日上午 9:57

The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website () after the live event.

直播结束后,可以在Aligos网站的 “科学演讲和会议” 部分()上找到这些演讲。

About 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 chronic hepatitis B (CHB) and coronaviruses.

关于 Aligos
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全球领导者。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,为代谢功能障碍相关性脂肪肝炎(MASH)和慢性乙型肝炎(CHB)和冠状病毒等医疗需求未得到满足的病毒发现和开发潜在的最佳疗法。

Forward-Looking Statement
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, statements that the company remains encouraged by the data presented showing a favorable safety profile and strong evidence of target engagement and continues to believe the molecule has the potential to be best-in-class; and with respect to ALG-000184, statements around the promising results contained in the three oral presentations demonstrating consistent effect in the reduction of key viral models, which results affirm the company's belief that this compound will play an essential role in the future treatment of hepatitis B. 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. 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 sufficiency of Aligos' capital resources to fund operations, reliance on third parties for manufacturing and development efforts, and the impact of global events and other macroeconomic conditions on the Aligos business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos' Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

前瞻性陈述
本新闻稿包含1995年《美国私人证券诉讼改革法》所指的前瞻性陈述。本新闻稿中任何非历史事实的陈述均可被视为 “前瞻性陈述”,包括但不限于与 ALG-055009 相关的陈述,这些陈述显示出良好的安全状况和有力的靶向参与证据,该公司仍然感到鼓舞,并继续认为该分子有可能成为同类最佳分子;对于 ALG-000184,有关三份口头陈述中显示出减少关键病毒效果一致的陈述模型,其结果证实了公司的信念,即这种化合物将在未来的乙型肝炎治疗中发挥至关重要的作用。前瞻性陈述通常使用 “可能”、“将”、“会”、“相信”、“打算”、“计划”、“预测”、“估计”、“期望” 等词语以及其他表示未来结果的类似术语来识别。此类前瞻性陈述存在重大风险和不确定性,可能导致我们的发展计划、未来业绩、业绩或成就与前瞻性陈述中的预期存在重大差异。此类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、监管机构的批准程序、监管机构申报的时机、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、其他可能影响Aligos资本资源充足运营资金的事项,对第三者的依赖派对用于制造和开发工作,以及全球事件和其他宏观经济条件对Aligos业务的影响。要进一步描述可能导致实际业绩与这些前瞻性陈述中的预期不同的风险和不确定性以及与Aligos总体业务相关的风险,请参阅Aligos于2024年3月12日向美国证券交易委员会提交的10-K表年度报告及其未来向美国证券交易委员会提交或提交的定期报告。除非法律要求,否则Aligos没有义务更新任何前瞻性陈述以反映新的信息、事件或情况,也没有义务反映意外事件的发生。

Contacts

联系人

Company
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
(650) 910-0427
jtarazi@Aligos.com

公司
乔丹·塔拉齐
投资者关系与企业传播副总裁
(650) 910-0427
jtarazi@Aligos.com

Media
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com

媒体
迈克尔·菲茨休
LifeSci
(628) 234-3889
mfitzhugh@lifescicomms.com


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