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Antios Therapeutics启动ATI-2173的人类首次I期研究 [复制链接]

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发表于 2020-2-13 12:37 |只看该作者 |倒序浏览 |打印

Antios Therapeutics Initiates First-in-Human Phase I Study of ATI-2173

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Antios Therapeutics, Inc.

Feb 12, 2020, 07:00 ET

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ATLANTA, Feb. 12, 2020 /PRNewswire/ -- Antios Therapeutics, Inc. ("Antios"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, today announced it has initiated its first-in-human Phase I clinical trial for ATI-2173, a novel liver-targeted, orally-administered, small molecule against hepatitis B. The Phase Ia study is a randomized, double-blind, placebo-controlled single-ascending dose ("SAD") study in healthy volunteers to evaluate the compound's safety, tolerability and pharmacokinetic profile.

This SAD study will be conducted in up to 35 healthy subjects randomized into 5 cohorts of 7 subjects each. A Phase Ib multiple-ascending dose ("MAD") clinical study in HBV-infected subjects is planned to commence following the completion of the SAD and MAD cohorts for the Phase Ia study.

"Dosing the first patients with ATI-2173 is a significant milestone for our company and we are very excited to initiate the first-in-human study of our liver-targeted, non-chain terminating, HBV polymerase inhibitor," said Abel De La Rosa, Ph.D., CEO of Antios.

"We are looking forward to learning more about ATI-2173 in the clinic after obtaining very encouraging preclinical antiviral activity and preclinical safety data for our lead molecule," said Douglas Mayers M.D., CMO of Antios.

Additional information can be found on www.clinicaltrials.gov

About ATI-2173

ATI-2173 is a novel liver-targeted molecule designed to deliver the 5'-monophosphate of clevudine. This L-nucleoside's active 5'-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor. By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the active 5'- triphosphate, ATI-2173 could become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

CONTACT: [email protected]

SOURCE Antios Therapeutics, Inc.
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https://www.antiostherapeutics.com/

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发表于 2020-2-13 12:37 |只看该作者
Antios Therapeutics启动ATI-2173的人类首次I期研究

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Antios Therapeutics,Inc.

东部时间2020年2月12日,07:00

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亚特兰大,2020年2月12日,美国-Antios Therapeutics,Inc.(以下简称“ Antios”)是一家临床阶段的生物制药公司,致力于开发治​​疗和治疗病毒性疾病的创新疗法,今天宣布已启动其首个- ATI-2173(一种针对肝脏的新型口服,针对乙型肝炎的小分子)在人体的I期临床试验。Ia期研究是一项随机,双盲,安慰剂控制的单次递增剂量(“ SAD” ”)在健康志愿者中进行研究,以评估该化合物的安全性,耐受性和药代动力学特征。

该SAD研究将在多达35位健康受试者中进行,随机分为5组,每组7位受试者。计划在完成Ia期研究的SAD和MAD队列之后,开始进行HBV感染受试者的Ib期多次上升剂量(“ MAD”)临床研究。

“对首批使用ATI-2173的患者而言,这对我们公司而言是一个重要的里程碑,我们很高兴对我们的针对肝脏的,非链终止的HBV聚合酶抑制剂进行首次人体研究。” Rosa,Antios首席执行官博士。

Antios的首席营销官Douglas Mayers M.D.说:“在获得非常令人鼓舞的临床前抗病毒活性和我们的前导分子的临床前安全性数据后,我们希望在临床上进一步了解ATI-2173。

可以在www.clinicaltrials.gov上找到更多信息。

关于ATI-2173

ATI-2173是一种新型的肝靶向分子,设计用于递送克列夫定的5'-单磷酸酯。这种L-核苷的活性5'-三磷酸酯具有非竞争性,非链终止性HBV聚合酶抑制剂的独特抗病毒特性。通过将5'-单磷酸酯双重递送至肝脏,同时保留活性5'-三磷酸酯独特的抗HBV活性,ATI-2173可以成为慢性乙型肝炎治疗联合方案不可或缺的一部分。

关于Antios Therapeutics Inc.

Antios Therapeutics是一家临床阶段的生物制药公司,致力于开发治​​疗和治愈病毒性疾病的创新疗法。 Antios目前正在开发ATI-2173,旨在为慢性乙型肝炎感染患者提供治愈性联合治疗方案。

联系人:[email protected]

消息来源Antios Therapeutics,Inc.
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发表于 2020-2-14 09:52 |只看该作者
本帖最后由 sky8989 于 2020-2-14 16:13 编辑

从乙肝治愈者血液中提取出对病毒有记忆的B细胞,再把这类细胞产生的能够对抗病原体的抗体分离出来,用来治疗其他的乙肝感染者。为什么这种方法不行?失败的原因在哪?
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