A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALG-055009 in Non-Cirrhotic Adults With Metabolic Dysfunction-Associated Steatohepatitis

This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks.

开始日期2024-04-01

申办/合作机构

Aligos Therapeutics, Inc.

NCT06191991

/ Completed临床1期

A Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential Between ALG-055009 and Statin Therapy(Ies)

This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs). In Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).

开始日期2023-11-03

申办/合作机构

Aligos Therapeutics, Inc.

NCT05090111

/ Completed临床1期

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia, and an Open-Label Assessment of Bioavailability and Food-effect in Healthy Volunteers

A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia

开始日期2021-12-01

申办/合作机构

Aligos Therapeutics, Inc.

100 项与 ALG-055009 相关的临床结果

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100 项与 ALG-055009 相关的转化医学

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100 项与 ALG-055009 相关的专利（医药）

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项与 ALG-055009 相关的文献（医药）

2024-09-12·Journal of Medicinal Chemistry

Discovery and Preclinical Profile of ALG-055009, a Potent and Selective Thyroid Hormone Receptor Beta (THR-β) Agonist for the Treatment of MASH

Article

作者: Deval, Jerome ; Lv, Zhidan ; Serebryany, Vladimir ; Luong, Xuan G. ; Lin, Tse-I ; Maskos, Klaus ; Vandyck, Koen ; Hu, Haiyang ; Raboisson, Pierre ; Jekle, Andreas ; Lammens, Alfred ; Gupta, Kusum ; Misner, Dinah L. ; Beigelman, Leonid N. ; Chanda, Sushmita ; Blatt, Lawrence M. ; McGowan, David C. ; Symons, Julian A. ; Stevens, Sarah K. ; Stoycheva, Antitsa D. ; Williams, Caroline ; Welch, Michael

Agonists of thyroid hormone receptor β (THR-β) decreased LDL cholesterol (LDL-C) and triglyceride (TG) levels in human clinical trials for patients with dyslipidemia. The authors present the highly potent and selective compound ALG-055009 (14) as a potential best in class THR-β agonist. The high metabolic stability and good permeability translated well in vivo to afford a long in vivo half-life pharmacokinetic profile with limited liability for DDI, and it overcomes certain drawbacks seen in recent clinical candidates.

项与 ALG-055009 相关的新闻（医药）

2025-03-26

·GlobeNewswire-Health Care

Aligos Therapeutics Presents Positive Data at APASL 2025

SOUTH SAN FRANCISCO, Calif., March 26, 2025 (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 positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China. “We are pleased to present preliminary data out to 96 weeks in our Phase 1 study of ALG-000184, which continues to demonstrate first-/best-in-class reductions in important HBV markers,” stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. “Additionally, the HERALD data from the Phase 2a study of ALG-055009 in MASH subjects demonstrated robust reductions in liver fat, with a subgroup analysis in subjects on stable GLP-1 agonist therapy, showing a potential role for ALG-055009 in combination with other therapies.” Two oral presentations will highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B virus (HBV) infection in both HBeAg-positive and HBeAg-negative subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure. Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated HBV DNA suppression (

临床结果临床2期临床1期

2024-11-25

·生物制药小编

Q3被百济二股东清仓的Biotech

2024Q3高瓴旗下专注于美股持仓的HHLR大规模减少了持仓企业，持仓呈现出集中化的特点，而同为百济股东之一的Baker Brother本季度的变动反而没有那么显著。在新建仓几家Biotech的同时，也清仓了几家Biotech。Baker Brother的清仓是较为合理的，在本季度这些企业或多或少都出现了一些问题。 Sage Therapeutics Sage公司在本季度迎来了危急时刻，今年的早些时候该公司的核心管线——NDMA受体调节剂dalzanemdor在阿尔兹海默症和帕金森症中先后失败，因此这直接导致公司在上个月出现了一波裁员潮。更悲剧的是最近该公司宣布，Dalzanemdor也未能改善成年亨廷顿舞蹈症患者的认知功能。这意味着这家公司目前只能寄托于和渤健合作的Zurzuvae销售额不会太难看。 Baker Brother在今年第一季度建仓了Sage，现在清仓也说明可能失算了。 Aligos Therapeutics 数据很好但是股价下跌是Aligos Therapeutics的最直接反映，这家以非酒精性脂肪肝药物为卖点的公司在本季度公布了核心管线THR-β激动剂ALG-055009临床数据。作为首款MASH药物Rezdiffra的挑战者，ALG-055009需要证明自己有独到优势。 Baker Brother建仓该公司于Q1，也算是一种看好。然而，尽管数据史无前例地好，但是投资人觉得临床中存在问题，ALG-055009的临床中并没有严格筛选掉以前服用过GLP-1药物的受试者。同时，安慰剂组的数据疑似太好了，按理来说应该出现患者肝脏脂肪下降的情况，但ALG-055009的临床中竟然反常地增加了。这些不合理之处让这家公司走势破朔迷离。 Athira Pharma Athira Pharma在本季度迎来了核心管线fosgonimaton的重大失利，fosgonimaton是一种用于治疗中枢神经系统疾病的HGF/MET系统的皮下小分子阳性调节剂。然而，该药物在针对阿尔茨海默病的II/III期LIFT-AD试验中未能达到主要和关键的次要终点，导致公司股价大幅下跌。 Adaptimmune Therapeutics “Biotech憋了多年，终于迎来了产品上市，可没有人看好未来前景，股价一路走低，前景暗淡，债台高筑”这样的事件就发生在Adaptimmune身上。作为推动首款TCR-T疗法Afami-cel上市的企业，有太多里程碑可以颁发给Adaptimmune，但是商业化前景上，没人看好Afami-cel会是个重磅炸弹。适应症软组织肉瘤本身就是一类肿瘤中的罕见疾病，考虑到高昂的价格，在产品上市的里程碑后，这家公司的股价反而一路走低。本季度内一直徘徊于1美元左右。 Achilles Therapeutics 相比于上述几家公司，Achilles Therapeutics的情况就没有那么好了，现在这家英国公司已经走到了破产边缘，已经着手探寻“价值最大化”战略。9月份时，在没有看到临床数据希望的情况下，这家公司决定放弃最后一款TILs管线的两个临床，这使得该公司目前已经没有任何在研管线。总结总的来说，Baker Brother本季度变动不大，从总体来看前十大持仓总体价值提高，这可能和Baker Brother主要注重生物制药有关，而HHLR的不少持股变动可能反映了对美国大选中概股影响的合理反馈。

细胞疗法

2024-11-19

·GlobeNewswire-Health Care

Aligos Therapeutics Presents Positive Data at The Liver Meeting (TLM) 2024

SOUTH SAN FRANCISCO, Calif., Nov. 19, 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 positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024, being held November 15 – 19, 2024 in San Diego, CA. The clinical poster presentation highlighted the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) virus infection in both HBeAg-positive and HBeAg-negative subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure. Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (

临床结果临床2期

100 项与 ALG-055009 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非酒精性脂肪性肝炎	临床2期	美国	Aligos Therapeutics, Inc.	2024-04-01
高脂血症	临床1期	法国	Aligos Therapeutics, Inc.	2021-12-01

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06342947 (HERALD, GlobeNewswire) 人工标引	临床2期	非酒精性脂肪性肝炎	102	ALG 055009 0.3 mg	(範膚獵衊構鏇襯淵獵夢) = 鑰蓋醖築糧製夢選簾繭觸淵選夢蓋製選蓋醖鏇 (壓觸鏇構襯鬱壓範鬱淵 ) 达到	积极	2024-09-19
				ALG 055009 0.5 mg	(範膚獵衊構鏇襯淵獵夢) = 蓋構選淵鏇築蓋醖廠鬱觸淵選夢蓋製選蓋醖鏇 (壓觸鏇構襯鬱壓範鬱淵 ) 达到
GlobeNewswire 人工标引	临床1期	高脂血症	-	ALG-055009	(壓膚獵製衊簾廠艱襯獵) = Expected thyromimetic effects were observed: dose-dependent increases in sex hormone binding globulin levels (SHBG) and decreases in lipid levels 構選壓製膚構廠齋觸鏇 (鑰築願獵窪顧顧鏇蓋襯 ) 更多	积极	2023-12-07
GlobeNewswire 人工标引	临床1期	高胆固醇血症	-	ALG-055009 1.0 mg	(憲顧築廠簾窪壓蓋糧製) = well tolerated with no safety signals identified 獵齋餘艱淵簾鹽壓窪憲 (簾遞襯積簾壓淵醖願顧 ) 更多	积极	2023-11-13
NCT05090111 (Corporate Publications) 人工标引	临床1期	高脂血症	40	ALG-055009	(選製醖壓願構餘築範繭) = There were no serious adverse events, dose-limiting toxicities, or TEAEs leading to premature discontinuation 糧簾蓋鹹壓淵鏇簾窪鏇 (構糧夢襯築鹽衊選淵簾 )	积极	2022-11-04
				Placebo