Aligos Therapeutics 在第一阶段概念验证研究中开始在健康志愿者

StephenW

Aligos Therapeutics 在第一阶段概念验证研究中开始在健康志愿者中使用反义寡核苷酸候选药物 ALG-020572给药

阿里戈斯疗法
2021 年 10 月 11 日，星期一，晚上 11:00·5 分钟阅读
在本文中：

Aligos 现在正在临床试验中评估其四种慢性乙型肝炎 (CHB) 组合候选药物中的三种

加利福尼亚州南旧金山，2021 年 10 月 11 日（环球新闻社）——Aligos Therapeutics, Inc.（纳斯达克股票代码：ALGS）是一家临床阶段的生物制药公司，专注于开发新型疗法，以满足病毒和肝脏疾病未满足的医疗需求，今天宣布，该公司已开始在研究 ALG-020572-401 (NCT05001022) 的第一批健康志愿者中给药。该试验正在评估 ALG-020572，这是一种专有的反义寡核苷酸 (ASO) 治疗候选药物，旨在降低循环 HBsAg（乙型肝炎表面抗原）水平。

“这是我们已推进到临床开发的第二个候选药物，其目标是减少慢性乙型肝炎患者的 HBsAg，”Aligos 董事长兼首席执行官 Lawrence Blatt 博士、MBA 说。 “我们的 ASO 分子的机制专门设计用于选择性地寻找和破坏病毒信使 RNA，并利用旨在改善分子药理特性的第三代 XNA 化学。我们希望这些增强的特性将增强候选者在临床中的抗病毒活性。”

ALG-020572-401 研究的首席研究员、MB ChB 教授 Ed Gane 补充说：“我相信降低 HBsAg 水平是实现功能性治愈的必要步骤。其他 ASO 已证明临床上 HBsAg 显着减少。鉴于 ALG-020572 似乎比其他 ASO 具有更有效的抗病毒活性和通过 GalNAc 增强的肝细胞靶向，包含 ALG-020572 的联合方案可能有可能实现更高的功能治愈率。”

研究 ALG-020572-401 是一个由两部分组成的伞式协议。在第 1 部分，它将评估单次皮下 (SC) 剂量的 ALG-020572 在健康志愿者中的安全性、耐受性和药代动力学 (PK)。在第 2 部分中，它将评估在多个慢性乙型肝炎 (CHB) 亚群中给予超过 28 天的多次 SC 剂量的安全性、PK 和抗病毒活性。

Aligos 的 ASO 计划是该公司 CHB 产品组合中针对乙型肝炎病毒生命周期中不同临床验证作用机制的几个项目之一。该产品组合还包括 S-抗原转运抑制寡核苷酸聚合物 (STOPSTM) 分子、衣壳组装调节剂 (CAM) 和小干扰 RNA (siRNA) 候选药物。这些候选药物的特性表明，它们的组合使用可能会产生潜在的同类最佳治疗方案，其功能治愈率可能比当前的护理标准更高。对于这些候选药物中的每一种，Aligos 计划首先在 1 期伞形试验中建立作为单一疗法的概念证明，然后在后续试验中对它们进行组合评估。

StephenW

Aligos Therapeutics Begins Dosing with Antisense Oligonucleotide Drug Candidate, ALG-020572, in Healthy Volunteers in a Phase 1 Proof-of-Concept Study

Aligos Therapeutics
Mon, October 11, 2021, 11:00 PM·5 min read
In this article:

Aligos now evaluating three of its four chronic hepatitis B (CHB) portfolio drug candidates in clinical trials

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company has started dosing in the first cohort of healthy volunteers in Study ALG-020572-401 (NCT05001022). The trial is evaluating ALG-020572, a proprietary antisense oligonucleotide (ASO) therapeutic candidate that is designed to reduce circulating HBsAg (Hepatitis B surface antigen) levels.

“This is the second drug candidate we have advanced to clinical development that targets HBsAg reductions in chronic hepatitis B patients,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “The mechanism of our ASO molecule is specifically designed to selectively seek out and destroy viral messenger RNA and utilizes third generation XNA chemistry devised to improve the pharmacological characteristics of the molecule. We are hopeful these enhanced properties will augment the candidate’s antiviral activity in the clinic.”

Professor Ed Gane, MB ChB, Principal Investigator for the ALG-020572-401 study, added, “I believe that reducing HBsAg levels is an essential step in achieving functional cure. Other ASOs have demonstrated substantial HBsAg reductions in the clinic. Given that ALG-020572 appears to have more potent antiviral activity and enhanced hepatocyte targeting via GalNAc than other ASOs, a combination regimen containing ALG-020572 may have the potential to achieve higher rates of functional cure.”

Study ALG-020572-401 is a two-part umbrella protocol. In Part 1, it will evaluate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) doses of ALG-020572 in healthy volunteers. In Part 2, it will evaluate the safety, PK, and antiviral activity of multiple SC doses given over 28 days in multiple chronic hepatitis B (CHB) subpopulations.

Aligos’s ASO program represents one of several in the company’s CHB portfolio that target different clinically validated mechanisms of action in the hepatitis B virus life cycle. The portfolio also includes S-antigen Transport-inhibiting Oligonucleotide Polymer (STOPSTM) molecules, capsid assembly modulators (CAMs), and small interfering RNA (siRNA) drug candidates. The properties of these candidates indicate that their use in combination could yield potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.

newchinabok

十年之内用不起，药价一定贵

lancas

如果真的能治愈，就算用不起也是一件好事了~~~~~