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标题: Antios Therapeutics 在 EASL International Liver Congress™ 2022 上宣布 ATI- [打印本页]

作者: StephenW    时间: 2022-6-9 12:31     标题: Antios Therapeutics 在 EASL International Liver Congress™ 2022 上宣布 ATI-

Antios Therapeutics 在 EASL International Liver Congress™ 2022 上宣布 ATI-2173、ATI-1428 和 ATI-1645 乙型肝炎病毒计划的口头报告

美国东部时间 2022 年 6 月 8 日 07:00
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宾夕法尼亚州道尔斯顿,2022 年 6 月 8 日 /美通社/ -- Antios Therapeutics, Inc. (Antios) 是一家临床阶段的生物制药公司,致力于开发创新疗法以推进治疗,从而为治愈慢性乙型肝炎病毒 (HBV) 提供桥梁),今天宣布接受口头报告,重点介绍 ATI-2173,Antios 的主要治疗性 HBV 候选药物和唯一用于 HBV 临床开发的活性位点聚合酶抑制剂核苷酸 (APIN),以及 ATI-1428 和 ATI-1645,来自 Antios 的候选药物第 4 代衣壳组装调节剂 (CAM) 程序。这些演讲将于 2022 年 6 月 22 日至 26 日在英国伦敦的 ExCeL 伦敦展览中心举行的 2022 年欧洲肝脏研究协会 (EASL ILC 2022) 上进行。

Antios 将展示 ATI-2173 与富马酸替诺福韦二吡呋酯 (TDF) 联合进行的为期 90 天的 2a 期研究。这项对 20 名成年患者进行的双盲、随机、安慰剂对照研究旨在评估与 TDF 加安慰剂(对照)相比,每天 25 和 50 毫克剂量的 ATI-2173 与 TDF 联合治疗 90 天的疗效和安全性。慢性HBV感染者。主要终点包括出现不良反应的患者百分比和 HBV 病毒载量复发的时间。除了不良反应,作为主要安全终点的一部分,安全性评估记录了所有治疗组的治疗后 ALT 突然发作。

Antios 还将提供来自 ATI-1428 和 ATI-1645 的临床前数据,这些数据正处于研究性新药开发中。这些候选药物是 II 类 CAM,具有新颖独特的超强作用机制设计,可以为免疫系统提供更有针对性和有益的抗病毒反应。迄今为止,这两种化合物在转基因小鼠模型中的数据为有效的体外和体内活性、出色的药代动力学特征以及在肝细胞质中没有空衣壳的积累提供了初步证据。

Antios 首席执行官 Greg Mayes 说:“我们将 ATI-2173 视为通往治愈的桥梁——这是最终寻求治愈 HBV 的重要第一步。” “迄今为止,数据一直令人鼓舞,表明将 ATI-2173 与核苷类似物(如 TDF)结合在一个简单的、每天一次的方案中,有可能完全关闭 HBV 聚合酶活性和病毒复制。我们期待在即将举行的国际肝脏大会上展示我们的 2a 期数据以及我们 CAM 计划的初始数据。”
Antios Therapeutics EASL ILC 2022 演示详情:

标题:ATI-2173(一种新型活性位点聚合酶抑制剂核苷酸)与富马酸替诺福韦二吡呋酯联合治疗慢性乙型肝炎患者的持续 12 周的抗病毒疗效,2a 期临床试验 (#296)

     作者/主持人:Douglas Mayers, M.D.
     演讲类型:口头演讲
     日期/时间:英国夏令时 2022 年 6 月 25 日上午 9:15

标题:新型超强效衣壳组装调节剂可防止乙型肝炎病毒感染小鼠模型中空衣壳的异常积累和相关的 T 细胞介导的肝损伤 (#291)

     作者/主持人:Luca Guidotti, M.D., Ph.D.
     演讲类型:口头演讲
     日期/时间:英国夏令时 2022 年 6 月 25 日下午 5:30

关于 ATI-2173

ATI-2173 是 Antios Therapeutics 的主要每日一次口服候选药物,用于治疗 HBV,是一种在研的磷酸胺前体药物 clevudine monophosphate。如果获得批准,ATI-2173 有可能成为潜在治愈 HBV 的桥梁。它是临床开发中唯一用于 HBV 的活性位点聚合酶抑制剂核苷酸 (ASPIN),其作用机制旨在与其他寻求功能性治愈的方法相辅相成。
关于 ATI-1428 和 ATI-1645

ATI-1428 和 ATI-1645 是第 4 代 II 类衣壳组装调节剂 (CAM),两者均具有新颖独特的超强效作用机制设计,可提供免疫系统更有针对性、更有成效的抗病毒反应。这些 CAM 源自一种新型化学支架,在 HBV 感染的转基因小鼠模型中显示出强大的体外和体内活性。作为基于最初的临床前小鼠研究的具有超强设计诱导空衣壳积累的 CAM,ATI-1428 和 ATI-1645 代表了临床开发的有希望的候选者,并已进入研究性新药开发阶段。 ATI-1428 和 ATI-1645 于 2021 年 11 月由 Antios 从 San Raffaele Hospital (OSR)、Istituto Nazionale Genetica Molecolare (INGM) 和 IRBM/Promidis(意大利研究机构和全球合同研究组织的合作组织)收购。
作者: StephenW    时间: 2022-6-9 12:31

Antios Therapeutics Announces Oral Presentations on ATI-2173, ATI-1428, and ATI-1645 Hepatitis B Virus Programs at the EASL International Liver Congress™ 2022

Jun 08, 2022, 07:00 ET
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DOYLESTOWN, Pa., June 8, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to advance treatments that can provide a bridge to a cure for chronic hepatitis B virus (HBV), today announced the acceptance of oral presentations highlighting ATI-2173, Antios' lead therapeutic HBV candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and ATI-1428 and ATI-1645, candidates from Antios' 4th generation capsid assembly modulators (CAM) program. These presentations will be given at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL ILC 2022), taking place June 22 – 26, 2022 at the ExCeL London Exhibition Centre in London, UK.

Antios will be presenting the 90-day, Phase 2a study of ATI-2173 in combination with tenofovir disoproxil fumarate (TDF). This double-blind, randomized, placebo-controlled study of 20 adult patients was designed to assess the efficacy and safety of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with TDF compared with TDF plus placebo (control) in chronic HBV-infected subjects. The primary endpoints included the percentage of patients experiencing adverse reactions and time to HBV viral load relapse. In addition to adverse reactions, as a part of the primary safety endpoint, the safety evaluations recorded off-treatment ALT flares in all treatment groups.

Antios will also present preclinical data from ATI-1428 and ATI-1645, which are in investigational new drug enabling development. These candidates are class II CAMs with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted and beneficial antiviral response by the immune system. To date, data in a transgenic mouse model for both compounds provide initial evidence for potent in vitro and in vivo activity, an excellent pharmacokinetic profile, and no accumulation of empty capsids in the hepatocellular cytoplasm.

"We see ATI-2173 as a bridge to a cure – an important first step in the ultimate search for a cure for HBV," said Greg Mayes, Chief Executive Officer of Antios. "To date, the data have been encouraging, indicating that combining ATI-2173 with a nucleoside analogue such as TDF in a simple, once-a-day regimen has the potential to completely shut down HBV polymerase activity and viral replication. We look forward to presenting our Phase 2a data, as well as the initial data from our CAM program, at the upcoming International Liver Congress."
Antios Therapeutics EASL ILC 2022 Presentation Details:

Title: Sustained 12-week off treatment antiviral efficacy of ATI-2173, a novel active site polymerase inhibitor nucleotide, combined with tenofovir disoproxil fumarate in chronic hepatitis B patients, a phase 2a clinical trial (#296)

     Author/Presenter: Douglas Mayers, M.D.
     Presentation Type: Oral Presentation
     Date/Time: June 25, 2022, at 9:15am BST

Title: Novel ultra-potent capsid assembly modulators prevent abnormal accumulation of empty capsids and associated T-cell mediated liver injury in a mouse model of hepatitis B virus infection (#291)

     Author/Presenter: Luca Guidotti, M.D., Ph.D.
     Presentation Type: Oral Presentation
     Date/Time: June 25, 2022, at 5:30pm BST

About ATI-2173

ATI-2173, Antios Therapeutics' lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to be a bridge to a potential cure for HBV. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure.
About ATI-1428 and ATI-1645

ATI-1428 and ATI-1645 are 4th generation, class II capsid assembly modulators (CAMs), both with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted, productive antiviral response by the immune system. Derived from a novel chemical scaffold, these CAMs have shown strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. As CAMs with an ultrapotent design inducing no accumulation of empty capsids based on an initial preclinical mouse study, ATI-1428 and ATI-1645 represent promising candidates for clinical development and have entered investigational new drug enabling development. ATI-1428 and ATI-1645 were acquired by Antios in November of 2021 from San Raffaele Hospital (OSR), Istituto Nazionale Genetica Molecolare (INGM), and IRBM/Promidis, a collaboration of Italian research institutes and a global contract research organization.
作者: pppq123    时间: 2022-6-9 22:14

英国夏令时 2022 年 6 月 25 日下午 5:30
会出临床数据吗?
作者: 乙肝人1949    时间: 2022-6-10 22:44






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