Antios Therapeutics 和 Assembly Biosciences 宣布签署临床合作协议，

StephenW

Antios Therapeutics 和 Assembly Biosciences 宣布签署临床合作协议，以评估 ATI-2173 和 Vebicorvir 联合治疗慢性乙型肝炎病毒感染患者的疗效

新泽西州门德姆和加利福尼亚州南旧金山，2021 年 10 月 19 日——Antios Therapeutics, Inc. 和 Assembly Biosciences, Inc.（纳斯达克股票代码：ASMB）今天宣布，两家公司已达成一项临床合作协议，以评估三联疗法慢性乙型肝炎病毒（HBV）感染患者的治疗。正在进行的 Antios 2a 期 ANTT201临床试验中的一个单一队列将评估 ATI-2173、Antios 的研究专有活性位点聚合酶抑制剂核苷酸 (ASPIN)、vebicorvir (VBR)、Assembly Bio 的研究先导核心抑制剂候选药物和富马酸替诺福韦二吡呋酯核苷酸逆转录酶抑制剂。

多中心、双盲、安慰剂对照队列将评估这种全口服三联疗法的安全性、药代动力学和抗病毒活性。该队列预计将于 2022 年上半年开始，并将在为期 12 周的治疗研究中招募 10 名未经治疗或停止治疗的 HBeAg 阴性或阳性患者。

“Antios 专注于为慢性 HBV 感染者开发功能性治疗方法。迄今为止，ATI-2173 已证明具有普遍良好耐受性的安全性，在临床开发中利用独特的 ASPIN 机制为联合治疗提供支持。最终，ATI-2173 有可能成为与其他药物（如维比考韦）联合治疗慢性 HBV 的每日一次治疗方案的基石，”Antios 首席执行官 Gregory Mayes 说。

“我们与 Antios 的合作强调了我们致力于评估我们的核心抑制剂和核苷（酸）类似物的骨架，并结合其他机制来治疗 HBV，这是一种慢性感染的原因，可导致更高的肝硬化和死亡风险。肝癌，” AO 医学博士、Assembly Bio 首席执行官兼总裁 John McHutchison 说。 “我们和 Antios 共同致力于为 HBV 寻求有限和治愈性疗法，这将我们团结在这些研究工作中，并为患者带来希望。”

关于 ATI-2173

ATI-2173 是 Antios Therapeutics 用于治疗 HBV 的每日一次的主要口服候选药物，是一种研究性的氯磺定单磷酸酯的氨基磷酸酯前药。如果获得批准，ATI-2173 有可能成为治愈性 HBV 治疗方案的基石。它是临床开发中唯一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实现功能性治愈的方法互补。 ATI-2173目前处于2期临床开发阶段。 SAVE-1（持续抗病毒功效）试验是一项针对 30 名成年患者的持续、双盲、随机、安慰剂对照研究，旨在评估每天 25 和 50 毫克剂量的 ATI-2173 的安全性和有效性，持续 90与 TDF 加 ATI 安慰剂（对照）相比，在慢性 HBV 感染受试者中联合富马酸替诺福韦二吡呋酯 (TDF) 的天数。

关于 Vebicorvir，Assembly Bio 的主要 HBV 核心抑制剂

Assembly Bio 的 HBV 产品组合包括三种在研小分子候选药物，所有这些都是针对 HBV 复制周期多个步骤的 HBV 核心抑制剂。在 2 期临床试验中，第一代核心抑制剂维比可韦 (VBR) 与核苷（酸）类似物逆转录酶抑制剂 (NrtI) 治疗一起显示出良好的安全性，并导致对 HBV DNA 和 HBV pgRNA 的病毒抑制比 NrtI 更强单独治疗。 VBR 正在多项第 2 阶段联合研究中取得进展。

StephenW

Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients with Chronic Hepatitis B Virus Infection

MENDHAM, N.J., and SOUTH SAN FRANCISCO, Calif., October 19, 2021 – Antios Therapeutics, Inc. and Assembly Biosciences, Inc. (Nasdaq: ASMB) today announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial  will evaluate ATI-2173, Antios’ investigational proprietary active site polymerase inhibitor nucleotide (ASPIN), vebicorvir (VBR), Assembly Bio’s investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor.

The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics, and antiviral activity of this all-oral triple combination. This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naïve or off-treatment HBeAg negative or positive patients in a 12-week treatment study.

“Antios is focused on developing a functional cure for people living with chronic HBV. ATI-2173 has, to date, demonstrated a generally well-tolerated safety profile, leveraging a unique ASPIN mechanism in clinical development to empower combination therapy. Ultimately, ATI-2173 has the potential to become a cornerstone of a once-daily curative regimen in combination with other agents, like vebicorvir, for the treatment of chronic HBV,” said Gregory Mayes, Chief Executive Officer of Antios.

“Our collaboration with Antios emphasizes our commitment to evaluating the backbone of our core inhibitors plus a nucleos(t)ide analogue in combination with other mechanisms to treat HBV, a cause of chronic infection that can lead to a higher risk of death from cirrhosis and liver cancer,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. “The commitment that we and Antios share to pursue finite and curative therapies for HBV unites us in these research efforts and offers hope for patients.”

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 become the cornerstone of a curative HBV regimen. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure. ATI-2173 is currently in Phase 2 clinical development. The SAVE-1 (Sustained Anti-Viral Efficacy) trial is an ongoing, double-blind, randomized, placebo-controlled study of 30 adult patients designed to assess the safety and efficacy of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with tenofovir disoproxil fumarate (TDF) compared with TDF plus ATI-placebo (control) in chronic HBV-infected subjects.

About Vebicorvir, Assembly Bio’s Lead HBV Core Inhibitor

Assembly Bio’s HBV portfolio includes three investigational small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.