Aligos Therapeutics提交了针对慢性乙型肝炎衣壳组装调节剂候选

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Aligos Therapeutics Submits Clinical Trial Application for Chronic Hepatitis B Capsid Assembly Modulator Candidate ALG-000184
Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial
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August 24, 2020 10:17 ET | Source: Aligos Therapeutics

SOUTH SAN FRANCISCO, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPSTM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)
CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos
Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
[email protected]

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
[email protected]

StephenW

Aligos Therapeutics提交了针对慢性乙型肝炎衣壳组装调节剂候选药物ALG-000184的临床试验申请
Aligos CHB产品组合中的第二个候选药物进入临床试验
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东部时间2020年8月24日10:17 |资料来源：Aligos Therapeutics

2020年8月24日，加利福尼亚州南旧金山-全球领先的临床阶段生物制药公司Aligos Therapeutics，Inc.（Aligos）今天宣布，该公司致力于开发新型疗法以解决病毒和肝脏疾病中未满足的医疗需求它已向新西兰药品和医疗器械安全局提交了一项临床试验申请（CTA），以进行人类首次1a / b期概念验证试验（ALG-000184-201）。该试验正在评估ALG-000184，这是一种针对B型肝炎病毒（HBV）衣壳装配的小分子II类衣壳装配调节剂（CAM）以及共价闭合环状DNA（cccDNA）的调控和转录。

“这对Aligos疗法而言是一项重大成就，” Aligos首席执行官MBA博士Lawrence Blatt说道。 “从在埃默里大学雷蒙德·夏纳兹（Raymond Schinazi）博士的实验室中发现的新型CAM化合物开始，我们的团队在过去两年中进行了合作，以进一步改进CAM技术。这项工作最终导致了ALG-000184的发现，该产品具有最佳的药代动力学特性和亚纳摩尔效价。 ALG-000184似乎是迄今为止已进入临床开发的最有力的II类CAM候选药物，我们很高兴看到其增强的特性如何在临床试验中转化。”

ALG-000184-201是一项多阶段的1a / 1b总括试验，旨在评估健康志愿者和慢性乙型肝炎患者每天口服一次ALG-000184最多28天的安全性，药代动力学和抗病毒活性。 CHB）。 Aligos首席医学官Matthew McClure博士说：“我们的目标是将我们的STOPSTM 1期候选药物与ALG-000184一起进入临床，并与每种候选药物同时进行1期临床试验，然后再将它们进行联合试验。” “我们认为，通过推进具有加性或协同抗病毒活性的特制治疗药物组合，我们可能能够显着改善当前标准护理药物所见的低功能治愈率。”

Aligos的CAM程序是其CHB开发产品组合中的四类化合物之一，其中还包括STOPS（抑制S抗原转运的寡核苷酸聚合物），反义寡核苷酸（ASO）和小干扰RNA（siRNA）候选药物。

关于慢性乙型肝炎（CHB）
慢性乙型肝炎是慢性肝病的主要原因，据世界卫生组织估计，这种疾病影响全世界约2.57亿人，人数超过丙型肝炎病毒（HCV）和HIV感染的总和。 CHB的严重并发症包括肝硬化和肝癌，这与死亡率高相关。仅在2015年，就有约90万人死于与CHB相关的原因，并且死亡率在数十年来一直在上升。尽管当前针对CHB患者的护理标准可有效抑制HBV，但它与功能治愈率非常低相关，这是CHB治疗的主要目标。

关于阿里戈斯
Aligos Therapeutics，Inc.是一家私有的临床阶段生物制药公司，成立于2018年，其使命是成为病毒感染和肝病治疗的全球领导者。 Aligos致力于开发针对慢性乙型肝炎（CHB）和冠状病毒的针对性抗病毒疗法，并利用其在肝脏疾病方面的专业知识来开发针对非酒精性脂肪性肝炎（NASH）的针对性疗法。 Aligos的策略是利用其员工在肝脏疾病（尤其是病毒性肝炎）方面拥有的深厚专业知识和数十年的药物开发经验，以快速推进其潜在最佳分子产品的开发。

请访问www.aligos.com了解更多信息。

媒体联络
艾米·乔布（Amy Jobe）博士
生命科学通讯
+1 315 879 8192
[email protected]

投资者联系
科里·戴维斯（Corey Davis）博士
生命科学顾问
+1 212 915 2577
[email protected]