Vir Biotech 提供慢性乙型肝炎病毒功能性治愈的新数据

StephenW

Vir Biotech 提供慢性乙型肝炎病毒功能性治愈的新数据
通过丽莎法律
2022 年 11 月 8 日 - 3 分钟


Vir Biotechnology, Inc. 今天（11 月 8 日）公布了其强大的乙型肝炎病毒 (HBV) 产品组合的新数据，旨在实现功能性治愈。这些数据以及健康结果研究正在美国肝病研究协会 (AASLD) 上公布。

肝病会议以两次口头报告的形式进行，均被选入最佳肝病会议摘要、海报和最新的海报报告。最佳肝病会议的称号突显了 Vir 广泛的肝炎产品组合的实力，该产品涉及 HBV 和丁型肝炎病毒 (HDV)。

在一次口头报告中，来自正在进行的 2 期试验的新初步数据表明，接受 48 周 VIR-2218（一种研究性小干扰核糖核酸 (siRNA)，与聚乙二醇干扰素 α 同时启动）的参与者中有 30.8% 获得了乙型肝炎表面抗原(HBsAg) 血清清除与抗 HBs 血清转换。
维尔生物技术

此外，与单独使用 VIR-2218 或使用较短的组合方案相比，48 周的 VIR-2218 加聚乙二醇化干扰素 α 提供了更大的 HBsAg 降低。没有发现新的安全信号。

香港大学胃肠病学和肝病学系主任袁文峰博士说：“这些新的初步数据表明，聚乙二醇干扰素等免疫调节剂可以增强 VIR-2218，从而实现有意义的 HBsAg 下降。

“在 48 周治疗结束时，HBsAg 血清学清除率较高，抗 HBs 血清学转换可能表明该方案有可能作为有限持续时间的治愈性慢性 HBV 治疗。”

在单独的口头报告中，2 期 3 月（单克隆抗体 siRNA 组合抗乙型肝炎）试验的 A 部分的新结果（包括所有三个队列）显示平均 HBsAg 降低小于 2.5 log10 IU/mL。
功能性固化

这些数据表明，VIR-2218 和 VIR-3434 是一种研究中的靶向 HBsAg 的单克隆抗体，被设计成可能用作治疗性疫苗，它们有助于降低 HBsAg。在 A 部分中，通过长达 20 周的治疗，VIR-2218 和 VIR-3434 的组合通常具有良好的耐受性。

将 VIR-2218 加 PEG-IFN-α 试验的经验与这些令人鼓舞的新结果相结合，导致更多的队列评估 VIR-2218、VIR-3434 和 PEG-IFN-α 的三重组合被添加到 B 部分三月审判。 B 部分的初始数据预计将在 2023 年下半年发布。

此外，以海报形式展示的 1 期数据表明，单次 75 mg 或 300 mg 剂量的 VIR-3434 导致大多数患有慢性 HBV 感染且无核仁的病毒血症参与者的 HBsAg 和 HBV DNA 快速降低ide 逆转录酶抑制剂 (NRTI) 治疗。
乙型肝炎

最后，对美国 20 年医疗记录的真实世界分析（将在最新的海报展示中突出显示）显示，大多数慢性 HBV 感染者在整个研究期间仍未得到治疗。

Vir 临床研究高级副总裁兼慢性感染负责人 Carey Hwang 说：“我们正在进行的治疗组合试验的新数据继续支持我们将抗病毒药物与免疫调节剂相结合的策略，我们相信在我们的追求中向前迈出了令人鼓舞的一步为大约 3 亿慢性 HBV 感染者开发功能性治愈方法。
“我们对这些数据感到兴奋，这是我们开发新型 HBV 化合物 VIR-2218 和 VIR-3434 的重要里程碑。我们期待在 2023 年报告来自 Vir 最先进的开发项目之一的更多临床数据。”

StephenW

Vir Biotech presents new data for functional cure of chronic Hep B virus
By Liza Laws
November 8, 2022 - 3 minutes


Vir Biotechnology, Inc. today (November 8) announced new data from its robust hepatitis B virus (HBV) portfolio aimed at achieving a functional cure. These data, plus health outcomes research, are being presented at the American Association for the Study of Liver Diseases (AASLD).

The Liver Meeting was delivered in two oral presentations, both of which were selected for inclusion in the Best of the Liver Meeting summary, a poster and a late-breaking poster presentation. The Best of the Liver Meeting designation underscores the strength of Vir’s broad hepatitis portfolio, which is addressing both HBV and hepatitis D virus (HDV).

In one oral presentation, new preliminary data from an ongoing phase 2 trial demonstrated that 30.8% of participants receiving 48 weeks of VIR-2218, an investigational small interfering ribonucleic acid (siRNA), initiated concurrently with pegylated interferon alpha, achieved hepatitis B surface antigen (HBsAg) seroclearance with anti-HBs seroconversion.
Vir Biotech

Additionally, 48 weeks of VIR-2218 plus pegylated interferon alpha provided greater reductions in HBsAg compared to VIR-2218 alone or with shorter regimens of the combination. No new safety signals were identified.

Man-Fung Yuen, chief of division of gastroenterology and hepatology, The University of Hong Kong, said:  “These new preliminary data demonstrate that VIR-2218 can be potentiated by immunomodulating agents such as pegylated interferon to achieve meaningful HBsAg loss.

“The higher rates of HBsAg seroclearance with anti-HBs seroconversion by the end of the 48-week treatment could be indicative of the potential for this regimen to serve as a curative chronic HBV treatment with a finite duration.”

In a separate oral presentation, new results from part A of the phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial, including all three cohorts, demonstrated a mean HBsAg reduction of less than 2.5 log10 IU/mL.
Functional cure

These data showed that VIR-2218 and VIR-3434, an investigational HBsAg-targeting monoclonal antibody engineered to potentially act as a therapeutic vaccine, are additive in reducing HBsAg. The combination of VIR-2218 and VIR-3434 through up to 20 weeks of treatment in part A was generally well tolerated.

Combining the learnings from the VIR-2218 plus PEG-IFN-α trial with these encouraging new results have led to additional cohorts evaluating the triple combination of VIR-2218, VIR-3434 and PEG-IFN-α being added to Part B of the MARCH trial. Initial data from part B are expected in the second half of 2023.

Additionally, phase 1 data presented as a poster demonstrated that a single 75 mg or 300 mg dose of VIR-3434 resulted in rapid reductions in HBsAg and HBV DNA in the majority of viremic participants with chronic HBV infection in the absence of nucleot(s)ide reverse transcriptase inhibitor (NRTI) therapy.
Hepatitis B

Finally, a real-world analysis of 20 years of medical records in the U.S., to be highlighted in a late-breaking poster presentation, revealed that the majority of people with chronic HBV infection remained untreated throughout the study period.

Carey Hwang, Vir’s senior vice president, clinical research, head of chronic infection, said: “The new data from our ongoing therapeutic combination trials continues to support our strategy of combining an antiviral with an immunomodulator and we believe are encouraging steps forward in our pursuit of developing a functional cure for the approximately 300 million people living with chronic HBV.
“We are excited by these data, which are important milestones in the development of our novel HBV compounds VIR-2218 and VIR-3434. We look forward to reporting additional clinical data from one of Vir’s most advanced development programs in 2023.”