Aligos Therapeutics在亚太肝病研究协会第30届年会上介绍其慢性

StephenW

Aligos Therapeutics Presents Data for its Chronic Hepatitis B Drug Candidates at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver
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February 03, 2021 08:00 ET | Source: Aligos Therapeutics

SOUTH SAN FRANCISCO, Calif., Feb. 03, 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 will deliver four poster presentations at the 30th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL), taking place virtually from February 4 through February 6, 2021.

“We are proud to show progress for two of our clinical candidates from our chronic hepatitis B portfolio,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Both candidates are currently being evaluated in Phase 1a/b umbrella studies where we will evaluate each for antiviral activity in CHB patients following demonstration of safety and tolerability in healthy volunteers. These trials are part of a larger plan to develop highly effective treatments using combinations of multiple novel drugs from our portfolio. We look forward to advancing our other lead candidates targeting other viral mechanisms of action into the clinic alongside ALG-010133 and ALG-000184.”

Three of the presentations highlight encouraging data from Aligos’ two most advanced CHB candidates for development toward a combination therapy for chronic hepatitis B (CHB): STOPS™ (ALG-010133), a proprietary oligonucleotide designed to inhibit hepatitis B virus (HBV) S-antigen (or HBsAg) replication, and ALG-000184, a capsid assembly modulator (CAM), designed to inhibit HBV replication.

The first presentation, titled “Preclinical Efficacy and Pharmacokinetics of ALG-010133, an S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPS) for the Treatment of Chronic Hepatitis B (CHB)”, demonstrated that Aligos’ lead STOPS candidate inhibited S-antigen release from cells in several lines of human hepatocytes. In vivo, ALG-010133 demonstrated high, rapid and sustained exposure in the liver following single subcutaneous injections given to nonclinical species, predicting once-weekly dosing in humans. Further, a nonclinical multiple dosing study in which animals were given three weekly subcutaneous doses demonstrated sufficient concentrations in the liver sufficient for projected efficacy in human CHB patients. Together, the combination of excellent in vitro efficacy and a favorable pharmacokinetic profile in vivo has justified ALG-010133’s progression to a Phase 1a/b trial for evaluation as a potential treatment for CHB.

A second presentation, “Safety, tolerability and pharmacokinetics of single ascending doses of ALG-000184, a Class II Capsid Assembly Modulator for the treatment of Chronic Hepatitis B (CHB), in healthy volunteers (HV)”, outlined preliminary data supporting further evaluation of Aligos’ small molecule candidate ALG-000184 in healthy volunteers and in CHB patients, as planned in the ongoing Phase 1a/b trial. At single oral doses of up to 500 mg, ALG-000184 was safe, well-tolerated and demonstrated a linear pharmacokinetic profile supporting once-daily oral dosing. Doses of 100 mg or higher resulted in plasma concentrations of active compound that are projected to result in antiviral activity in CHB patients.

Two other poster presentations entitled “Excellent preclinical characteristics of ALG-000184, a prodrug of the HBV capsid assembly modulator ALG-001075” and “ALG-020572, a next generation hepatitis B virus (HBV) antisense oligonucleotide (ASO) with bridged nucleic acid chemistry, has a significantly improved preclinical profile” highlight the nonclinical characteristics of ALG-000184 and its parent compound, ALG-001075, and ALG-020572, Aligos’ ASO candidate for chronic hepatitis B that significantly improves upon other ASOs in terms of nonclinical safety and efficacy.

StephenW

Aligos Therapeutics在亚太肝病研究协会第30届年会上介绍其慢性乙型肝炎药物候选者的数据
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美国东部时间2021年2月3日08:00 |资料来源：Aligos Therapeutics

2021年2月3日，加利福尼亚州南旧金山-全球领先的生物制药公司Aligos Therapeutics，Inc.（纳斯达克股票代码：ALGS）致力于开发新型疗法，以解决病毒和肝病中尚未满足的医疗需求，今天宣布，该公司将在2021年2月4日至2月6日举行的亚太肝病研究协会（APASL）第30届年会上作四场海报展示。

MBA博士Aligos首席执行官劳伦斯·布拉特（Lawrence Blatt）表示：“我们很自豪能够为我们的两个慢性乙型肝炎临床候选药物取得进展。” “目前正在1a / b期总括研究中对这两种候选药物进行评估，在健康志愿者证明其安全性和耐受性之后，我们将评估每种药物在CHB患者中的抗病毒活性。这些试验是一项更大计划的一部分，该计划将使用我们产品组合中的多种新型药物来开发高效治疗药物。我们期待着将针对其他病毒作用机制的其他主要候选人与ALG-010133和ALG-000184一起推广到诊所。”

其中三个演讲重点介绍了来自Aligos的两个最先进的CHB候选药物的令人鼓舞的数据，这些候选药物正在发展用于慢性B型肝炎（CHB）的联合疗法：STOPS™（ALG-010133），一种旨在抑制B型肝炎病毒（HBV）S的专有寡核苷酸-抗原（或HBsAg）复制和ALG-000184，衣壳装配调节剂（CAM），旨在抑制HBV复制。

第一个演讲题目为“ ALG-010133的临床疗效和药代动力学，ALG-010133是一种抑制S抗原转运的寡核苷酸聚合物（STOPS），用于治疗慢性乙型肝炎（CHB）”，表明Aligos的主要STOPS候选物抑制了S抗原。从人肝细胞几系中的细胞释放。在体内，ALG-010133在非临床种类的皮下注射后，在肝脏中表现出高，快速和持续的暴露，预示着人类每周给药一次。此外，一项非临床的多剂量研究表明，动物每周皮下注射三剂，证明肝脏中足够的浓度足以对人CHB患者产生预期的疗效。综合起来，优异的体外功效和良好的体内药代动力学特征相结合，证明了ALG-010133正在进行1a / b期临床试验以评估其作为CHB的潜在治疗方法的合理性。

第二份报告“单次上升剂量的ALG-000184，用于治疗健康志愿者（HV）的慢性乙型肝炎（CHB）的II类衣壳装配调节剂ALG-000184的安全性，耐受性和药代动力学”概述了支持进一步评估的初步数据按照正在进行的1a / b期临床试验的计划，在健康志愿者和CHB患者中使用Aligos的小分子候选物ALG-000184。在最高500 mg的单次口服剂量下，ALG-000184是安全的，耐受性良好的，并且表现出线性药代动力学特征，支持每天一次口服给药。 100 mg或更高的剂量会导致血浆活性化合物浓度升高，预计会在CHB患者中产生抗病毒活性。

其他两个海报演讲分别是“ ALG-000184，HBV衣壳装配调节剂ALG-001075的前体药物的卓越临床前特性”和“ ALG-020572，下一代具有桥连核酸的乙型肝炎病毒（HBV）反义寡核苷酸（ASO）”化学，具有显着改善的临床前特征”，突出了ALG-000184及其母体化合物ALG-001075和ALG-020572的非临床特征，这是Aligos的慢性乙肝ASO候选药物，在非临床安全性方面显着改善了其他ASO和功效。