Antios Therapeutics在SAVE 1中治疗第一例患者，这是ATI-2173在慢性

StephenW

Antios Therapeutics Doses First Patients in SAVE 1, a Phase 2a Study of ATI-2173 in Patients with Chronic Hepatitis B Virus (HBV)

Published: Apr 21, 2021

SAVE 1 to evaluate ATI-2173 in combination with tenofovir (TDF) vs. TDF plus placebo

SAVE 1 to include cohort of Hepatitis Delta Virus (HDV) co-infected subjects to assess ATI-2173 activity against HDV

MENDHAM, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Antios Therapeutics, Inc. (“Antios”) today announced that it has dosed the first patients in its Sustained Anti-Viral Efficacy (SAVE) clinical trial, a Phase 2a study of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development as a backbone of a potentially curative regimen for chronic HBV.

The double-blind randomized controlled trial plans to enroll 30 patients and will assess the safety and efficacy of 25mg and 50mg doses of ATI-2173 in combination with tenofovir (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects. A third cohort will evaluate 50mg of ATI-2173 and TDF against the control arm in HBV/HDV co-infected subjects. Efficacy will be assessed by both on-treatment maximum HBV DNA level responses and by off-treatment sustained virologic responses (SVR)s for the treatment arms in HBV-mono-infected subjects and by HDV RNA treatment responses in the HBV/HDV-coinfected subjects.

Following a screening period of up to eight weeks, subjects will be randomized to receive either once-daily, oral ATI-2173 plus TDF arm or control for 12 weeks, after which they will be evaluated off therapy during a 24-week follow-up period. Subjects’ HBV DNA will be measured regularly during both the treatment and follow-up periods. Subjects whose HBV DNA remains undetectable at six months post-treatment will be followed for up to an additional 18 months. Additional details of the clinical trial are available on clinicaltrials.gov (NCT04847440).

“We saw evidence of durable on- and off-treatment viral suppression in the Phase 1b study where ATI-2173 monotherapy was given for only 28 days,” said Gregory Mayes, chief executive officer of Antios. “We believe that the unique ability of ATI-2173 to inhibit all stages of HBV DNA synthesis could generate additional SVRs following three months of finite treatment in combination with the standard of care, TDF, potentially turning HBV from a chronic disease to a curable one for some patients.”

Douglas Mayers, chief medical officer of Antios added, “In addition to determining the ability of ATI-2173 to generate increased levels of SVR, this will be an extremely important study, as it may also provide proof-of-concept for the drug to be used as a treatment for HDV. Preclinical work in woodchuck models of HBV/HDV coinfection has demonstrated the ability of ATI-2173’s active metabolite to significantly reduce HDV RNA levels. This would be a tremendously promising finding if replicated in humans, as effective treatment of HDV remains a high unmet need. We anticipate completing dosing for SAVE 1 before the end of 2021 and presenting the results at a future scientific conference.”

About ATI-2173
ATI-2173 is a novel, orally administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver where it is metabolized to the active 5’-triphosphate. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to 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.

CONTACTS

Investors:
Lee Roth
Burns McClellan
[email protected]
+1 (212) 300-8331

StephenW

Antios Therapeutics在SAVE 1中治疗第一例患者，这是ATI-2173在慢性乙型肝炎病毒（HBV）患者中进行的2a期研究

发布时间：2021年4月21日

保存1以评估ATI-2173联合替诺福韦（TDF）与TDF加安慰剂的比较

SAVE 1包括肝炎三角洲病毒（HDV）共感染受试者队列，以评估ATI-2173对HDV的活性

2021年4月21日，新泽西州曼德姆（GLOBE NEWSWIRE）-Antios Therapeutics，Inc.（以下简称“ Antios”）今天宣布，已在其2A阶段的持续抗病毒疗效（SAVE）临床试验中给予首批患者剂量。 ATI-2173是一种活性位点聚合酶抑制剂核苷酸（ASPIN），在临床开发中作为慢性HBV潜在治疗方案的骨干。

该双盲随机对照试验计划招募30名患者，并将评估25mg和50mg剂量的ATI-2173联合替诺福韦（TDF）与TDF联合ATI-安慰剂（对照）在慢性HBV感染中的安全性和有效性科目。第三个队列将评估HBV / HDV合并感染受试者相对于对照组的50mg ATI-2173和TDF。疗效将通过治疗中最大的HBV DNA水平反应和治疗后持续性病毒学应答（SVR）评估，以针对HBV单一感染受试者的治疗组以及通过HBV / HDV合并感染的HDV RNA治疗反应科目。

经过长达八周的筛选期后，受试者将被随机分配接受每日一次口服ATI-2173加TDF臂或对照组的治疗，持续12周，之后将在24周的随访中对他们进行非治疗评估时期。在治疗和随访期间，将定期测量受试者的HBV DNA。治疗后六个月仍无法检测到HBV DNA的受试者将被随访长达18个月。有关临床试验的更多详细信息，请访问Clinicaltrials.gov（NCT04847440）。

Antios首席执行官Gregory Mayes说：“我们在1b期研究中看到了持久的治疗和非治疗性病毒抑制的证据，其中仅进行ATI-2173单药治疗28天。” “我们相信，ATI-3173抑制HBV DNA合成的所有阶段的独特能力，在经过三个月的有限治疗并与标准的TDF相结合后，可能会产生更多的SVR，从而可能将HBV从慢性疾病转变为可治愈的疾病。对于某些患者。”

Antios首席医学官Douglas Mayers补充说：“除了确定ATI-2173产生增加的SVR的能力外，这将是一项极为重要的研究，因为它也可能为该药物提供概念验证。用作HDV的治疗方法。 HBV / HDV合并感染的土拨鼠模型的临床前研究表明，ATI-2173的活性代谢产物具有显着降低HDV RNA水平的能力。如果在人类中复制，这将是一个非常有希望的发现，因为对HDV的有效治疗仍然是高度未满足的需求。我们预计将在2021年底之前完成SAVE 1的给药，并在未来的科学会议上展示结果。”

关于ATI-2173
ATI-2173是一种新颖的，口服给药的，以肝脏为靶点的活性位点聚合酶抑制剂核苷酸（ASPIN）分子，旨在将克列夫定的5'-单磷酸递送至肝脏，在肝脏中将其代谢为活性的5'-三磷酸。这种L-核苷的活性5'-三磷酸酯具有独特的抗病毒特性，作为一种非竞争性，无链终止的HBV聚合酶抑制剂，会扭曲HBV聚合酶的活性位点，从而导致有效的HBV抗病毒活性和对HBV DNA的长期治疗抑制作用。 ATI-2173靶向肝脏，可提供高水平的独特5'-三磷酸酯，同时限制了对母体L-核苷的全身性暴露。 ATI-2173有可能成为慢性乙型肝炎治愈性联合疗法不可或缺的一部分。

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。

联系方式

投资者：
李·罗斯
伯恩斯·麦克莱伦（Burns McClellan）
[email protected]
+1（212）300-8331