乙型肝炎治疗发布积极的研究数据

StephenW

乙型肝炎治疗发布积极的研究数据
2022 年 3 月 30 日 • 下午 4:02 CDT
来自Pixabay的luvqs
（精准疫苗）

总部位于宾夕法尼亚州的 Antios Therapeutics , Inc .今天公布了 ATI-2173 的 1b 期和 2a 期临床试验的新数据，ATI-2173 是其研究性专利候选药物，也是乙型肝炎病毒 (HBV) 临床开发中唯一的活性位点聚合酶抑制剂核苷酸 (APIN) ）。

这些数据表明，单独使用 ATI-2173 或与富马酸替诺福韦二吡呋酯 (TDF) 联用通常在队列中具有良好的耐受性。

ATI-2173 和 TDF 抑制 HBV DNA 并诱导 cccDNA 活性的生物标志物下降。

这些试验的数据将在海报会议中展示，重点如下：

    将 ATI-2173 与链终止核苷（酸）类似物 TDF 相结合，可有效抑制 HBV DNA 并诱导 cccDNA 活性的生物标志物下降。
    ATI-2173 作为单一疗法并与 TDF 联合使用，可降低循环 HBV RNA，其动力学与 HBV DNA 相似。
    接受 ATI-2173 和 TDF 联合治疗的患者在治疗结束时具有正常的丙氨酸氨基转移酶 (ALT) 水平或低于正常上限 1 倍的 ALT 水平，这表明该化合物可以使用长达 90 天。
    许多接受 ATI-2173 与 TDF 联合治疗的患者在治疗结束时均低于定量限。
    将 ATI-2173 成功靶向肝脏大大降低了血液中氯夫定的全身暴露，这可能会提高安全性和有效性。
    ATI-2173 在 25 毫克和 50 毫克每天一次的剂量下显示出耐受性。初步药代动力学数据分析显示 ATI-2173 和 TDF 之间没有药物相互作用。所有受试者完成给药而没有严重不良事件或导致研究药物中止的不良事件。

“随着我们继续了解乙型肝炎病毒的潜在治疗方案，这些数据很重要，并增强了我们对联合治疗/治疗后抑制的全部潜在影响的理解，”内科医学教授 Nancy Reau 医学博士说。拉什医学院肝病科主任，在 2022 年 3 月 30 日发布的新闻稿中。

“我们看到了联合治疗的潜在临床益处。”

例如，“在 2a 期研究中，没有接受 ATI-2173 与 TDF 联合治疗的患者出现 ALT 突然停止治疗，每位患者都完成了长达 90 天的联合治疗。”

美国疾病预防控制中心表示，乙型肝炎是由 HBV 引起的肝脏感染，可导致慢性感染，从而导致肝硬化和肝癌的死亡风险更高。

尽管有有效的疫苗和目前的治疗方案，但每年仍有大约 900,000 人死于与慢性 HBV 感染相关的并发症。

肝炎疫苗新闻发布在 PrecisionVaccinations.com/hepatitis。

注意：为了清晰起见，这篇新闻文章编辑了新闻声明，并为移动读者整理了它。
—
员工审查

StephenW

Hepatitis B Treatment Posts Positive Study Data
March 30, 2022 • 4:02 pm CDT
luvqs from Pixabay
(Precision Vaccinations)

Pennsylvania-based Antios Therapeutics, Inc. today announced new data from the Phase 1b and 2a clinical trials of ATI-2173, its investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for hepatitis b virus (HBV).

These data showed that ATI-2173 alone or combined with tenofovir disoproxil fumarate (TDF) was generally well-tolerated among the cohorts.

And ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.

Data from these trials will be presented in poster sessions, which are highlighted below:

    Combining ATI-2173 with TDF, a chain-terminating nucleos(t)ide analogue, potently suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.
    ATI-2173, as a monotherapy and in combination with TDF, decreased circulating HBV RNA with similar kinetics to HBV DNA.
    Patients receiving ATI-2173 and TDF combination treatment had normal alanine aminotransferase (ALT) levels or ALT levels less than 1x the upper limit of normal at the end of treatment, demonstrating the ability to administer this compound for up to 90 days.
    Many of the patients receiving ATI-2173 in combination with TDF were below the limit of quantification at the end of treatment.
    Successful targeting of ATI-2173 to the liver greatly decreased systemic exposure to clevudine in the blood, which may lead to enhanced safety and efficacy.
    ATI-2173 showed tolerability at 25 mg and 50 mg once-daily doses. Preliminary pharmacokinetic data analyses showed no drug-drug interaction between ATI-2173 and TDF. All subjects completed dosing without serious adverse events or adverse events leading to study drug discontinuation.

"As we continue to understand potential treatment options for the hepatitis B virus, these data are important and augment our understanding of the full potential effects of the combination on/off-treatment suppression," said Nancy Reau, M.D., Professor of Internal Medicine and Hepatology Section Head at Rush Medical College, in a press release issued on March 30, 2022.

"We are seeing potential clinical benefits in combination treatment."

For example, "in the Phase 2a study, no patients receiving ATI-2173 in combination with TDF had an ALT flare off-treatment, and every patient completed the combination treatment for up to 90 days."

Hepatitis B is a liver infection caused by HBV that can cause chronic infection, which leads to a higher risk of death from cirrhosis and liver cancer, says the U.S. CDC.

Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

Hepatitis vaccine news is posted at PrecisionVaccinations.com/hepatitis.

Note: This news article edited the press statement for clarity and curated it for mobile readers.
—
Staff Review

StephenW

Antios Therapeutics 的 ATI-2173 在 1b 期和 2a 期研究中展示了对乙型肝炎病毒的抑制作用

    ATI-2173 表现出有效的乙型肝炎病毒 (HBV) DNA 抑制
    ATI-2173 与富马酸替诺福韦二吡呋酯 (TDF) 联用，通常耐受性良好，丙氨酸氨基转移酶 (ALT) 正常化且无安全信号

宾夕法尼亚州道尔斯顿，2022 年 3 月 30 日 – Antios Therapeutics, Inc. (Antios) 是一家临床阶段的生物制药公司，开发治疗和治愈慢性乙型肝炎病毒 (HBV) 的创新疗法，今天公布了 1b 期和 2a 期临床的新数据ATI-2173的试验，它的研究专有药物候选和唯一的活性位点聚合酶抑制剂核苷酸（ASPIN）在乙肝的临床开发中。这些数据表明，单独使用 ATI-2173 或与富马酸替诺福韦二吡呋酯 (TDF) 联合使用在队列中通常具有良好的耐受性，并且 ATI-2173 和 TDF 抑制 HBV DNA 并诱导 cccDNA 活性的生物标志物下降。这些试验的数据将在 2022 年 3 月 30 日至 2022 年 4 月 3 日在韩国首尔举行的第 31 届亚太肝脏研究协会 (APASL) 会议期间的两个海报会议上展示。


APASL 海报展示的亮点

    将 ATI-2173 与链终止核苷（酸）类似物 TDF 相结合，可有效抑制 HBV DNA 并诱导 cccDNA 活性的生物标志物下降。
    ATI-2173 作为单一疗法并与 TDF 联合使用，可降低循环 HBV RNA，其动力学与 HBV DNA 相似。
    接受 ATI-2173 和 TDF 联合治疗的患者在治疗结束时具有正常的丙氨酸氨基转移酶 (ALT) 水平或低于正常上限 1 倍的 ALT 水平，这表明该化合物可以使用长达 90 天。
    许多接受 ATI-2173 与 TDF 联合治疗的患者在治疗结束时低于定量限 (BLQ)。
    将 ATI-2173 成功靶向肝脏大大降低了血液中氯夫定的全身暴露，这可能会提高安全性和有效性。
    ATI-2173 在 25 毫克和 50 毫克每天一次的剂量下显示出耐受性。初步药代动力学数据分析显示 ATI-2173 和 TDF 之间没有药物相互作用。所有受试者完成给药而没有严重不良事件或导致研究药物中止的不良事件。

“随着我们继续了解乙型肝炎病毒的潜在治疗方案，这些数据很重要，并增强了我们对联合治疗/停药抑制的全部潜在影响的理解，”内科和肝病学教授 Nancy Reau 医学博士说拉什医学院的科长。 “我们看到了联合治疗的潜在临床益处。在 2a 期研究中，没有接受 ATI-2173 与 TDF 联合治疗的患者出现 ALT 突然停止治疗，每位患者都完成了长达 90 天的联合治疗。”

演讲详情如下。海报和海报的口头介绍都可以在 Antios 网站上找到，网址为 https://www.antiostherapeutics.c ... ions-presentations/。

标题：SAVE-1：ATI-2173 的 2a 期结果，一种新型活性位点聚合酶抑制剂核苷酸，与 TDF 联合用于慢性乙型肝炎患者 (OP-0829)
作者/主持人：Douglas Mayers, M.D.
演讲类型：科学汇报会和海报展示

标题：活性位点聚合酶抑制剂核苷酸在治疗停止后诱导持续的 HBV RNA 抑制 (OP-0621)
作者/主持人：Katherine Squires，博士
展示类型：海报展示


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，是一种在研的磷酸氯夫定前药。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。 ATI-2173目前处于2a期临床开发阶段。 SAVE-1（持续抗病毒功效）试验是一项正在进行的、双盲、随机、安慰剂对照研究，对 30 名患者进行了评估，旨在评估每天 25 和 50 毫克剂量的 ATI-2173 90 天的安全性和有效性与富马酸替诺福韦酯 (TDF) 联用，与 TDF 加 ATI 安慰剂（对照）相比，慢性 HBV 感染受试者和一组 HDV 共感染受试者。

StephenW

Antios Therapeutics’ ATI-2173 Demonstrates Suppression of Hepatitis B Virus in Phase 1b and 2a Studies

    ATI-2173 demonstrated potent hepatitis B virus (HBV) DNA suppression
    ATI-2173, in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated with alanine aminotransferase (ALT) normalization and no safety signals

DOYLESTOWN, P.A., March 30, 2022 – Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced new data from the Phase 1b and 2a clinical trials of ATI-2173, its investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. These data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity. Data from these trials will be presented in two poster sessions during the 31st Conference of the Asian Pacific Association for the Study of Liver (APASL), taking place in Seoul, South Korea on March 30, 2022 – April 3, 2022.


Highlights from the APASL Poster Presentations

    Combining ATI-2173 with TDF, a chain-terminating nucleos(t)ide analogue, potently suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.
    ATI-2173, as a monotherapy and in combination with TDF, decreased circulating HBV RNA with similar kinetics to HBV DNA.
    Patients receiving ATI-2173 and TDF combination treatment had normal alanine aminotransferase (ALT) levels or ALT levels less than 1x the upper limit of normal at the end of treatment, demonstrating the ability to administer this compound for up to 90 days.
    Many of patients receiving ATI-2173 in combination with TDF were below the limit of quantification (BLQ) at the end of treatment.
    Successful targeting of ATI-2173 to the liver greatly decreased systemic exposure to clevudine in the blood, which may lead to enhanced safety and efficacy.
    ATI-2173 showed tolerability at 25 mg and 50 mg once-daily doses. Preliminary pharmacokinetic data analyses showed no drug-drug interaction between ATI-2173 and TDF. All subjects completed dosing without serious adverse events or adverse events leading to study drug discontinuation.

“As we continue to understand potential treatment options for the hepatitis B virus, these data are important and augment our understanding of the full potential effects of combination on/off-treatment suppression,” said Nancy Reau, M.D., Professor of Internal Medicine and Hepatology Section Head at Rush Medical College. “We are seeing potential clinical benefits in combination treatment. In the Phase 2a study, no patients receiving ATI-2173 in combination with TDF had an ALT flare off-treatment and every patient completed the combination treatment for up to 90 days.”

Details of the presentations are below. Both posters and oral presentations of the posters can be found on the Antios website at https://www.antiostherapeutics.c ... ons-presentations/.

Title: SAVE-1: Phase 2a Results of ATI-2173, A Novel Active Site Polymerase Inhibitor Nucleotide, Combined with TDF in Chronic Hepatitis B Patients (OP-0829)
Author/Presenter: Douglas Mayers, M.D.
Presentation Type: Scientific Debrief Session and Poster Presentation

Title: Active Site Polymerase Inhibitor Nucleotides Induce Sustained HBV RNA Suppression Following Treatment Cessation (OP-0621)
Author/Presenter: Katherine Squires, Ph.D.
Presentation Type: Poster Presentation


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) 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. ATI-2173 is currently in Phase 2a clinical development. The SAVE-1 (Sustained Anti-Viral Efficacy) trial is an ongoing, double-blind, randomized, placebo-controlled study of 30 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, with a cohort of HDV coinfected subjects.

lancas

这药不错~~