A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)

A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection

开始日期2025-08-05

申办/合作机构

Vir Biotechnology, Inc.

NCT07128550

/ Recruiting临床3期

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide

开始日期2025-07-30

申办/合作机构

Vir Biotechnology, Inc.

ACTRN12625000416493

/ Not yet recruiting临床3期

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)

开始日期2025-05-29

申办/合作机构

Vir Biotechnology, Inc.

100 项与 Elebsiran 相关的临床结果

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100 项与 Elebsiran 相关的转化医学

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100 项与 Elebsiran 相关的专利（医药）

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项与 Elebsiran 相关的文献（医药）

2025-07-01·GASTROENTEROLOGY

The Impact of Hepatitis B Surface Antigen Reduction via Small Interfering RNA Treatment on Natural and Vaccine (BRII-179)-Induced Hepatitis B Virus-Specific Humoral and Cellular Immune Responses

Article

作者: Ma, Haiyan ; Tan, Ying ; Lee, Ariel ; Bertoletti, Antonio ; Chen, Jieliang ; Wang, Bing ; Zhu, Chong ; Lai-Hung Wong, Grace ; Douglas, Mark W ; Li, Dong ; Ji, Yun ; Chen, Xiaofei ; Yuen, Man-Fung ; Lv, Jianxiang ; Zhu, Qing ; Le Bert, Nina

BACKGROUND & AIMS:

The impact of hepatitis B surface antigen (HBsAg) reduction from small interfering RNA (siRNA) treatments on hepatitis B virus (HBV)-specific immunity of individuals with chronic hepatitis B (CHB) has not been adequately analyzed in humans. We conducted a phase 2a study treating CHB participants with nine 4-weekly doses of HBV-targeted siRNA elebsiran (BRII-835), either alone (n = 10) or in combination with a virus-like particle-based therapeutic vaccine (BRII-179) containing Pre-S1, Pre-S2, and S antigens, coadministered with (n = 39) or without (n = 41) interferon alfa.

METHODS:

We analyzed longitudinally for 72 weeks virologic, clinical, and immunologic parameters, including HBsAg, alanine aminotransferase, hepatitis B surface antibody (anti-HBs), the neutralizing activity of representative sera, and frequency and cytokine secretion ability of T cells specific for Pre-S1, Pre-S2, and S both directly ex vivo and after in vitro expansion.

RESULTS:

Combination therapy with elebsiran and BRII-179 was well tolerated. Although no sustained HBsAg seroclearance or notable difference in mean HBsAg reduction at the group level was observed, we detected marked heterogeneity in immunologic responses among groups. HBsAg reduction mediated by siRNA alone was associated with minimal HBV-specific immune response recovery. In contrast, combination of elebsiran with BRII-179 induced a significant modification of immune responses demonstrated by anti-HBs antibody production and an expansion of interleukin 2-producing helper T cells specific for Pre-S1/Pre-S2 antigens only. Importantly, anti-HBs antibodies persisted at ≥100 IU/L in ∼40% of the participants for at least 32 weeks after combined treatment. Moreover, the neutralizing ability of the anti-HBs-positive sera was associated with HBsAg reduction.

CONCLUSIONS:

siRNA-induced HBsAg reduction may contribute to the persistence and efficacy of the humoral arm of HBV-specific adaptive immunity in CHB participants receiving the therapeutic vaccine BRII-179.

CLINICALTRIALS:

gov number: NCT04749368.

2025-06-01·JHEP Reports

Therapy with murinized tobevibart and elebsiran is efficacious in a liver-chimeric mouse model of HDV infection

Article

作者: Terrell, Ashley N ; Lempp, Florian A ; Zhou, Jiayi ; Puschnik, Andreas S ; Corti, Davide ; Rocha, Evelyn ; Kaiser, Hannah ; Purcell, Lisa A

Background & Aims:

Chronic hepatitis delta virus (HDV) infection represents the most severe form of viral hepatitis. HDV is a satellite virus of hepatitis B virus (HBV) and depends on the hepatitis B surface antigen (HBsAg) for envelopment and viral entry. Tobevibart (VIR-3434) is an investigational monoclonal antibody targeting the antigenic loop of HBsAg. Elebsiran (VIR-2218) is an investigational RNAi therapeutic targeting a highly conserved region within the HBV genome. The aim of this study was to investigate the antiviral effect of tobevibart and elebsiran on HDV infection in preclinical models.

Methods:

In vitro antiviral activity was determined in an HBV/HDV coinfection model in primary human hepatocytes (PHHs) or Huh7-NTCP cells. The in vivo efficacy of a murinized version of tobevibart alone or in combination with elebsiran was evaluated in HBV/HDV-coinfected liver-chimeric mice.

Results:

Elebsiran treatment reduced levels of secreted HBsAg and infectious HDV with picomolar potency. Tobevibart exhibited pan-genotypic neutralizing activity against all tested HDV genotypes with EC₅₀ ranging from 1.1 to 4.6 ng/ml. Combination treatment with tobevibart and elebsiran reduced infectious HDV levels in HBV/HDV-coinfected PHHs in an additive manner. In vivo, compared to vehicle, treatment with elebsiran, murinized tobevibart, or their combination significantly decreased HDV RNA serum levels by 0.7 log (p <0.0001), 1.6 log (p = 0.0034) and 2.1 log (p = 0.0002), respectively (measured at day 14 for elebsiran or day 21 for murinized tobevibart and the combination). HBsAg serum levels were reduced by 0.6 log (p <0.0001), 2.0 log (p <0.0001) and 2.8 log (p <0.0001), respectively.

Conclusions:

Tobevibart and elebsiran exert potent antiviral activity as single agents and in combination. The data support the clinical development of tobevibart and elebsiran for the treatment of patients with chronic HDV infection.

Impact and implications:

Chronic hepatitis delta is the most severe form of viral hepatitis and is associated with rapid progression of liver-related diseases and a high risk of hepatocellular carcinoma development. To date, there are only limited treatment options available. Tobevibart and elebsiran are currently being evaluated in clinical trials for the treatment of HDV (phase III) and for the treatment of HBV (phase II). The current study demonstrates that tobevibart and elebsiran are efficacious in preclinical models of HBV/HDV coinfection, supporting their clinical development.

2024-12-01·Lancet Gastroenterology & Hepatology

VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study

Article

作者: Lim, Tien-Huey ; Yuen, Man-Fung ; Gane, Edward ; Cloutier, Daniel ; Yoon, Ki Tae ; Gupta, Sneha V ; Arizpe, Andre ; Lim, Young-Suk ; Mao, Shenghua ; Heo, Jeong ; Thanawala, Vaidehi ; Cathcart, Andrea L ; Tak, Won Young ; Hwang, Carey ; Tangkijvanich, Pisit

BACKGROUND:

Chronic hepatitis B virus (HBV) remains a global concern, with current treatments achieving low rates of HBsAg seroclearance. VIR-2218 (elebsiran), a small interfering RNA agent against HBV transcripts, reduces HBsAg concentrations. We aimed to evaluate the safety and antiviral activity of VIR-2218 with and without pegylated interferon-alpha-2a treatment in participants with chronic HBV.

METHODS:

This open-label, phase 2 study was conducted at 23 sites in six countries (New Zealand, Australia, Hong Kong, Thailand, South Korea, and Malaysia). Adults (aged 18-65 years) with chronic HBV infection without cirrhosis and with HBsAg more than 50 IU/mL and HBV DNA less than 90 IU/mL who were on continued nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) therapy for 2 months or longer were eligible. Participants were enrolled into one of six cohorts to receive VIR-2218 200 mg subcutaneously every 4 weeks, with or without 180 μg subcutaneous pegylated interferon-alfa-2a once per week. Cohort 1 received six doses of VIR-2218 (total 20 weeks); cohort 2 received six doses of VIR-2218 starting at day 1, plus 12 doses of pegylated interferon-alfa-2a starting at week 12 (total 24 weeks); cohort 3 received six doses of VIR-2218 and 24 doses of pegylated interferon-alfa-2a (total 24 weeks); cohort 4 received six doses of VIR-2218 and up to 48 doses of pegylated interferon-alfa-2a (total 48 weeks); cohort 5 received up to 13 doses of VIR-2218 and up to 44 doses of pegylated interferon-alfa-2a (total 48 weeks); and cohort 6 received three doses of VIR-2218 and 12 doses of pegylated interferon-alfa-2a (total 12 weeks). The primary endpoints were the incidence of adverse events and clinical assessments (including results of laboratory tests). Secondary endpoints were the mean maximum reduction of serum HBsAg at any timepoint; the proportion of participants with serum HBsAg seroclearance at any timepoint and for more than 6 months after the end of treatment; and the proportion of participants with anti-HBs seroconversion at any timepoint. For patients who were HBeAg-positive, we also assessed the proportion with HBeAg seroclearance or anti-HBe seroconversion at any timepoint. This study is registered with ClinicalTrials.gov, NCT03672188, and is ongoing.

FINDINGS:

Between July 2, 2020, and Nov 2, 2021, 124 individuals were screened for eligibility, 84 of whom were enrolled (15 in cohort 1, 15 in cohort 2, 18 in cohort 3, 18 in cohort 4, 13 in cohort 5, and five in cohort 6). Participants were predominantly HBeAg-negative, Asian, and male (66 [79%] participants were male and 18 [21%] were female). Most treatment emergent adverse events were grades 1-2. Three (20%) participants in cohort 1, four (27%) in cohort 2, eight (44%) in cohort 3, seven (39%) in cohort 4, six (46%) in cohort 5, and two (40%) in cohort 6 reported treatment-emergent adverse events related to VIR-2218. 12 (80%) participants in cohort 2, 12 (67%) in cohort 3, 14 (78%) in cohort 4, 13 (100%) in cohort 5, and three (60%) in cohort 6 reported treatment-emergent adverse events related to pegylated interferon-alfa-2a. Two (13%) participants in cohort 1 had elevations in alanine aminotransferase, compared with 13 (87%) participants in cohort 2, 15 (83%) in cohort 3, 17 (94%) in cohort 4, 11 (85%) in cohort 5, and three (60%) in cohort 6. The mean maximum change from baseline at any timepoint in HBsAg concentration was -2·0 log₁₀ IU/mL (95% CI -2·1 to -1·8) in cohort 1, -2·2 log₁₀ IU/mL (-2·5 to -1·8) in cohort 2, -2·5 log₁₀ IU/mL (-2·8 to -2·1) in cohort 3, -2·4 log₁₀ IU/mL (-3·1 to -1·8) in cohort 4, -3·0 log₁₀ IU/mL (-3·7 to -2·3) in cohort 5, and -1·7 log₁₀ IU/mL (-2·1 to -1·4) in cohort 6. 11 participants (one in cohort 2, one in cohort 3, five in cohort 4, and four in cohort 5) receiving VIR-2218 plus pegylated interferon-alfa-2a had HBsAg seroclearance at any timepoint. Of these, ten (91%; one in cohort 2, five in cohort 4, and four in cohort 5) had anti-HBs seropositivity. Six participants (one in cohort 2, three in cohort 4, and two in cohort 5) had sustained HBsAg seroclearance through to 24 weeks after the end of treatment. No participants receiving VIR-2218 monotherapy (cohort 1) or VIR-2218 plus pegylated interferon-alfa-2a 12-week regimen (cohort 6) had HBsAg seroclearance. 12 (42%) of 26 participants (one of four in cohort 1, two of six in cohort 2, four of seven in cohort 3, four of six in cohort 4, and one of three in cohort 5) who were HBeAg positive at baseline had HBeAg seroclearance or anti-HBe seroconversion.

INTERPRETATION:

The results of this phase 2 study support further development of VIR-2218 as a potential therapy for patients with chronic HBV infection. Additional clinical trials of VIR-2218 with and without pegylated interferon-alfa-2a in combination with an HBsAg-targeting monoclonal antibody are ongoing.

FUNDING:

Vir Biotechnology.

240

项与 Elebsiran 相关的新闻（医药）

2025-08-21

·美通社

腾盛博药发布最新公司业务进展及2025中期业绩报告

通过多项进行中的 IIb期临床研究推进乙型肝炎功能性治愈策略与健康元集团达成大中华区战略合作，加速重症用抗生素s oralimixin的研发充足的现金储备助力新药早期研发及合作伙伴战略公司将于香港时间 8月22日上午9:00（美国东部时间8月21日晚间9:00）举行电话会议（中文场）香港时间 8月21日晚间9:00（美国东部时间8月21日上午9:00）举行电话会议（英文场）中国北京和美国北卡罗来纳州达勒姆 2025年8月21日 /美通社/ -- 腾盛博药生物科技有限公司（"腾盛博药"、"我们"或"公司"，股票代码：2137.HK），一家致力于针对患者需求未被满足的疾病开发治疗方案，以改善患者健康状况和治疗选择的生物技术公司，今日发布了公司最新业务进展和截至2025年6月30日六个月的中期业绩。 2025年上半年，腾盛博药通过多项确证性IIb期临床试验（包括ENRICH和ENHANCE研究）迅速推进其核心乙型肝炎病毒（HBV）功能性治愈项目，旨在探索能实现更高HBV功能性治愈率的联合治疗方案。公司在2025年亚太肝病研究协会（APASL）年会和欧洲肝病研究协会（EASL）会议上发布了ENSURE研究队列4数据，提示通过BRII-179诱导的抗HBs应答实现患者富集策略的潜力，受此启发，公司已在ENHANCE研究中纳入了基于修订方案的新队列。该修订方案将评估一个新的三联治疗方案，即BRII-179和elebsiran联合治疗再追加短疗程聚乙二醇干扰素α（PEG-IFNα）的治疗。新队列已于2025年7月完成入组。除HBV管线外，腾盛博药与健康元药业集团（"健康元集团"）达成战略许可合作协议，推进soralimixin（BRII-693）在大中华区的开发。公司加大了对早期研发的投入以进一步拓展产品组合，并将继续寻求合作以提升现金流的持续性。通过行之有效的成本控制措施，腾盛博药仍保持充裕的资金储备，目前现金储备为2.899亿美金，足以支持推进其核心HBV功能性治愈项目的后期研发计划以及早期研发项目。腾盛博药董事长兼首席执行官洪志博士表示："2025年上半年我们在HBV项目上取得了重要进展，其中ENSURE研究的队列4数据令人鼓舞，ENRICH和ENHANCE研究也得到了快速推进。这些成果体现了腾盛博药为HBV慢性感染者开发创新性治愈疗法方面的丰富经验和坚定承诺。与此同时，soralimixin（BRII-693）在大中华区的对外授权以及我们对早期研发项目的持续投资，进一步强化了我们内部创新与战略性外部合作并驾齐驱的战略，以推动可持续增长。" 公司业务和临床进展 HBV项目腾盛博药继续推进其HBV管线，重点通过新型联合治疗方案实现更高的HBV功能性治愈率。公司正在推进多项正在进行的IIb期联合研究（ENSURE、ENRICH和ENHANCE），使用其差异化的HBV候选药物，包括靶向HBV的小干扰核糖核酸（siRNA）药物elebsiran和基于重组蛋白的HBV免疫疗法BRII-179。 BRII-179在ENSURE研究队列4中展现出令人鼓舞的结果，关键数据已在2025年APASL和EASL会议上公布： - 在第 48 周（治疗结束时 [EOT]），此前对BRII-179有应答的患者中，61%（11/18）实现了 HBsAg 血清清除，而无应答者中仅有10%（1/10）实现。在应答者中，91%（10/11）的患者抗HBs滴度≥100 IU/L。 - BRII-179 经治参与者实现了更快的HBsAg清除，其中83%（10/12）在第24周时实现了 HBsAg清除，而BRII-179未经治参与者中仅有55%（6/11）实现了HBsAg清除。 ENSURE研究结果表明，先前接受BRII-179/elebsiran治疗可诱导强烈的抗HBs应答，并使更可能实现 HBsAg清除的患者比例增加。这些数据还表明，大多数HBsAg清除可能在较短的PEG-IFNα治疗持续时间（24周）内实现。 ENSURE研究队列4的24周随访数据预计将于2025年下半年公布，并将在科学会议上进行展示。为了进一步明确BRII-179在HBV治疗中的作用，并确定推进至注册性研究的最佳联合用药方案，公司正在两项额外的IIb期临床试验中评估BRII-179： - ENRICH研究：评估BRII-179在诱导HBV特异性免疫应答和/或识别更可能实现功能性治愈的免疫应答患者中的作用。我们认为BRII-179可能在治愈性治疗方案中发挥独特作用。 - ENHANCE研究：评估BRII-179与elebsiran联合PEG-IFNα的三联治疗方案，以提高功能性治愈率。基于ENSURE研究队列4的洞察，我们对研究方案进行了修订，以评估一种简化的三联疗法，旨在将PEG-IFNα的治疗周期缩短至24周。所有研究均已完成患者招募。ENRICH和ENHANCE研究的治疗结束数据预计将于2026年上半年在科学会议上公布。本公司已与中国国家药品监督管理局（NMPA）药品审评中心（CDE）就潜在的III期研究设计和主要终点进行沟通。正在进行的ENRICH和ENHANCE研究的结果将决定最终哪种联合治疗方案将被推进至潜在的注册研究。其他临床项目腾盛博药正在积极寻求外部合作，以推动其针对HIV及多重耐药/广泛耐药（MDR/XDR）感染的治疗候选药物的研发与商业化进程。 2025年7月，公司宣布与健康元集团达成战略性对外授权协议，共同推进soralimixin（BRII-693）在大中华区的研发、开发及商业化。此次合作将借助健康元集团在抗感染治疗领域强大的专业能力，加速soralimixin（BRII-693）的研发进程并最大化其商业潜力。公司将继续为其寻求针对大中华区以外地区权益的非稀释性融资或合作机会。展望展望未来，腾盛博药将继续致力于为感染性疾病提供创新疗法，并持续专注于实现HBV功能性治愈。 HBV功能性治愈计划的关键数据预计将于2026年上半年公布，本公司已做好充分准备，将科学规划下一阶段的HBV功能性治愈临床策略。自去年任命新任首席科学官（CSO）以来，在持续推进核心HBV项目的同时，腾盛博药进一步壮大了内部早期研发团队并提升了能力。腾盛博药将继续加大早期研发投入，强化创新引擎，巩固其在生物技术突破领域的领先地位。 2025年中期财务业绩公司拥有充足的现金储备，以支持运营至2028年。截至2025年6月30日，公司的银行存款、现金及现金等价物为人民币20.753亿元，较截至2024年12月31日的人民币24.134亿元减少人民币 3.381 亿元，降幅为14.0%。该减少主要归因于研发活动及日常运营的支出。通过优化管线布局和资源配置、将部分临床开发活动转由内部执行以及对第三方承包商的成本优化措施，我们有效控制了运营支出。截至2025年6月30日的六个月期间，研发费用为人民币1.17亿元，较截至2024年6月30日的六个月期间的人民币1.262亿元减少人民币920万元，降幅为7.3%。公司在2025年上半年保持对核心项目的投入，同时审慎地推进了对研发管线的优化和组织精简。截至2025年6月30日的六个月期间，行政费用为人民币5,820万元，较截至2024年6月30日止的六个月期间的人民币7,860万元减少了人民币2,040万元，降幅为26.0%。该减少主要归因于组织优化和有效的成本控制，其中员工成本减少人民币950万元，及与办公场所相关的成本和专业服务费减少人民币840万元。截至2025年6月30日的六个月期间，其他收入为人民币2,810万元，较截至2024年6月30日的六个月期间的人民币7,090万元减少人民币4,280万元，降幅为60.4%。这主要归因于人民币和港元定期存款利率下降和短期存款重新配置至货币市场基金投资，导致的银行利息收入减少人民币2,160万元，以及来自政府补助的收入减少。电话会议信息公司将举办两场电话会议。英文场次将于8月21日晚9:00（香港时间，即美国东部时间上午9:00）举行（注册链接请点击此处），随后于8月22日上午9:00（香港时间，即美国东部时间8月21日晚9:00）举行中文场次（注册链接请点击此处）。所有参会者须在电话会议之前通过上述链接完成在线注册。此电话会议的回放将在会议后提供，并可通过访问本公司网站 www.briibio.com 的投资者关系版块获取。本新闻稿涉及第三方信息的引用。此类信息不应被视为参考信息纳入本新闻稿中。腾盛博药对此类第三方信息不负任何责任。关于腾盛博药腾盛博药（股票代码：2137.HK）是一家生物技术公司，致力于针对存在巨大未被满足的患者需求、治疗手段有限，以及给患者带来严重社会歧视的重大公共卫生挑战开发创新疗法。公司专注于感染性疾病，正在推进一条涵盖多种独特候选药物的产品管线，重点包括针对乙型肝炎病毒（HBV）感染的领先项目。在富有远见卓识和经验丰富的领导团队带领下，公司在位于罗利-达勒姆、旧金山湾区、北京和上海的主要生物技术中心开展业务。欲了解更多信息，请访问 www.briibio.com 。前瞻性声明本新闻稿中传达的信息包含某些具有或可能具有前瞻性的陈述。这些陈述通常包含诸如"将"、"期望"、"相信"、"计划"和"预期"等词语以及类似含义的词语。就其性质而言，前瞻性陈述涉及风险和不确定性，因为它们与事件相关并取决于未来将发生的情况。可能存在目前被认为不重要或本公司未意识到的其他重大风险。该等前瞻性陈述并非对未来业绩的保证。在此等不确定性的背景下，读者不应依赖该等前瞻性陈述。前瞻性陈述可能更新或根据未来的事件或发展进行相应修改，对此本公司不承担任何责任。

临床2期

2025-08-21

·PRNewswire

Brii Biosciences Provides Corporate Updates and Reports 2025 Interim Financial Results

Multiple Ongoing Phase 2b Studies Advancing HBV Functional Cure Strategy Greater China Partnership with Joincare to Accelerate Development of Critical Care Antibiotic soralimixin Strong Cash Position to Pursue New Discovery Opportunities and Partnership Strategy Conference Calls Scheduled: English Session: August 21 at 9:00 p.m. HKT / 9:00 a.m. ET Chinese Session: August 22 at 9:00 a.m. HKT / August 21 at 9:00 p.m. ET DURHAM, N.C., and BEIJING, Aug. 21, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical need, today provided a corporate update and reported its financial results for the six-month period ended June 30, 2025. In the first half of 2025, Brii Bio rapidly advanced its core hepatitis B virus (HBV) functional cure program through multiple confirmatory Phase 2b trials, including ENRICH and ENHANCE studies, seeking combination regimens with higher HBV functional cure rates. Encouraged by promising data from Cohort 4 of the ENSURE study, presented at both the Asian Pacific Association for the Study of the Liver (APASL) and the European Association for the Study of the Liver (EASL) Congress 2025 supporting the potential of its patient enrichment strategy through BRII-179 induced anti-HBs response, the Company initiated a new cohort in an amended protocol within the ENHANCE study. This amendment evaluates a new triple regimen cohort with BRII-179 and elebsiran combination treatment followed by an added short-course pegylated interferon alpha (PEG-IFNα) treatment. This new cohort was fully enrolled in July 2025. Beyond its HBV pipeline, Brii Bio entered into a strategic license collaboration with Joincare Pharmaceutical Group Industry Co., Ltd ("Joincare Group") for the development of soralimixin (BRII-693) in the Greater China region. The Company has expanded its new discovery efforts to further broaden its portfolio and will continue to pursue partnership to extend the cash runway. With effective cost control measures in place, Brii Bio remains well-capitalized, maintaining a cash position of US$289.9 million, which is sufficient to support its late-stage development plans for its core HBV functional cure program and early discovery initiatives. "We made significant strides in our HBV cure program during the first half of 2025, highlighted by encouraging data from Cohort 4 of the ENSURE study and the rapid advancement of ENRICH and ENHANCE studies." said Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio, "These achievements reflect Brii's experience and commitment to discovering innovative curative treatments for patients with chronic HBV infection. Meanwhile, the out-licensing of soralimixin in Greater China and our continued investment in early-stage discovery programs reinforce our strategy of combining internal innovation with strategic external collaborations to drive sustainable growth." Corporate and Clinical Updates HBV Program Brii Bio continues to advance its HBV pipeline with a strong focus on achieving higher rates of HBV functional cure through novel combination regimens. The Company is progressing multiple ongoing Phase 2b combination studies (ENSURE, ENRICH and ENHANCE) with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA, and BRII-179, a recombinant protein-based HBV immunotherapeutic. BRII-179 demonstrated encouraging results in the Cohort 4 of ENSURE study, with key data presented at APASL and EASL 2025: At Week 48 (end of treatment [EOT]), 61% (11/18) of patients who previously responded to BRII-179 achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among responders, 91% (10/11) developed anti-HBs titers ≥100 IU/L. BRII-179-experienced participants achieved faster HBsAg loss, with 83% (10/12) achieving loss by Week 24, versus 55% (6/11) in BRII-179 naïve participants. The ENSURE study results demonstrate that prior treatment with BRII-179 and elebsiran can induce robust anti-HBs responses and enrich for patients more likely to achieve HBsAg loss. These data also suggest that most HBsAg loss may be achievable with a shorter PEG-IFNα treatment duration (24 weeks). The 24-week follow-up data of Cohort 4 of ENSURE study are expected in 2H 2025 and will be presented at a scientific conference. To further define BRII-179's role in HBV treatment and identify the optimal combination regimen for advancement into a registrational study, the Company is assessing BRII-179 in two additional Phase 2b trials: ENRICH Study: Evaluates the role of BRII-179 in priming HBV-specific immunity and/or identifying immuno-responsive patients with a higher likelihood of achieving functional cure. We continue to believe that BRII-179 may play a unique role as part of the curative regimens. ENHANCE Study: Evaluates a triple combination treatment regimen of BRII-179 and elebsiran plus PEG-IFNα to enhance the functional cure rate. Based on insight from ENSURE Cohort 4, we amended the protocol to evaluate a simplified triple combination regimen aimed at shortening PEG-IFNα treatment duration to 24 weeks. All studies have been fully enrolled. EOT data from ENRICH and ENHANCE are expected to be presented at a scientific conference in the first half of 2026. The Company has engaged with CDE of NMPA on potential Phase 3 study design and primary endpoints. The results from the ongoing ENRICH and ENHANCE studies will inform which final combination regimen will be taken forward to potential registrational studies. Additional Clinical Programs Brii Bio is actively seeking external partnerships to advance the development and commercialization of its therapeutic candidates for HIV and multidrug-resistant/extensively drug-resistant (MDR/XDR) infections. In July 2025, the Company announced the strategic out-licensing agreement with Joincare Group for the research, development, and commercialization of soralimixin (BRII-693) in Greater China region. This collaboration will leverage Joincare Group's strong capabilities in anti-infective therapeutics to accelerate the development and maximize the commercial potential of soralimixin (BRII-693). The Company will continue to seek non-dilutive funding or partnership opportunities for rights outside of Greater China. Outlook Looking ahead, Brii Bio remains committed to delivering innovative therapies for infectious diseases, with a continued focus on achieving a functional cure for HBV. With key data readouts from its HBV functional cure program expected in the first half of 2026, the Company is well-positioned to make informed decisions that will shape the next phase of its HBV functional cure clinical strategy. Following the appointment of its new CSO last year, Brii Bio has further expanded its internal discovery team and capabilities, complementing the continued advancement of its core HBV program. Brii Bio will continue to scale up its early discovery efforts to strengthen its innovation engine and reinforce its position at the forefront of biotech breakthroughs. Interim 2025 Financial Results The Company maintains a strong cash position to support its operations through 2028. Our bank deposits and cash and cash equivalents were RMB2,075.3 million as of June 30, 2025, representing a decrease of RMB338.1 million or 14.0% compared with RMB2,413.4 million as of December 31, 2024. The decrease was primarily due to payout of research and development activities and daily operations. Through pipeline prioritization, resource optimization, internalization of certain clinical development activities, and cost-saving measures of third-party contractors, we have effectively controlled our operational expenses. Research and development expenses were RMB117.0 million for the six months ended June 30, 2025, representing a decrease of RMB9.2 million or 7.3%, compared with RMB126.2 million for the six months ended June 30, 2024. The decrease reflected disciplined pipeline prioritization and organizational streamlining, while maintaining continued investment in core programs during the first half of 2025. Administrative expenses were RMB58.2million for the six months ended June 30, 2025, representing a decrease of RMB20.4 million or 26.0%, compared with RMB78.6 million for the six months ended June 30, 2024. The decrease was primarily attributable to the decrease in employee cost of RMB9.5 million and the decrease in facility-related costs and professional service fees of RMB8.4 million, which was primarily attributable to organizational optimization and effective cost control. Other income was RMB28.1 million for the six months ended June 30, 2025, representing a decrease of RMB42.8 million or 60.4%, compared with RMB70.9 million for the six months ended June 30, 2024. This was mainly due to the decrease in bank interest income of RMB21.6 million attributable to the declining interest rates on CNY and HKD time deposits, reallocation of short-term deposits to money market fund investments, and the decrease in income recognized from PRC government grants. Conference Call Information The Company will host two live conference calls. The English session will be held August 21 at 9:00 p.m. HKT (9:00 a.m. ET), For the registration link, please click here. Followed by a Chinese session on August 22 at 9:00 a.m. HKT (9:00 p.m. ET on August 21). For the registration link, please click here. All participants shall use the link provided above to complete the online registration process prior to the conference call. A replay of the conference call will be available after the call and can be accessed by visiting the Company's website at under the Investor Relations section. This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information. About Brii Bio Brii Biosciences Limited ("Brii Bio," stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . Forward-Looking Statement The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. SOURCE Brii Biosciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期引进/卖出临床结果财报

2025-08-07

·PipelineReview

Vir Biotechnology Successfully Initiates all Trials in ECLIPSE Registrational Program for Chronic Hepatitis Delta

SAN FRANCISCO, CA, USA I August 06, 2025 I Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company’s registrational ECLIPSE program for chronic hepatitis delta (CHD) have now been initiated. ECLIPSE 3 is a Phase 2b trial designed to compare the combination of tobevibart and elebsiran to bulevirtide treatment in patients with CHD. ECLIPSE 3 will provide important supportive data to help establish access and reimbursement in key markets. “We believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” Share “People living with chronic hepatitis delta urgently need new options to treat their disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “With the strong foundation of our previous data and the proven expertise of our team, we believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” “We are encouraged by the high rates of viral suppression demonstrated by the combination of tobevibart and elebsiran in our Phase 2 SOLSTICE study,” said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. “Taken together, our ECLIPSE trials are designed to demonstrate the potential of our tobevibart and elebsiran combination therapy, including breadth of response and dosing convenience. These are key aspects for improving patients’ quality of life and supporting long-term treatment adherence in real-world settings.” CHD is an area of significant unmet medical need, with no approved treatments in the U.S. and limited options globally. CHD is the most severe form of chronic viral hepatitis, 1 with people living with the disease rapidly progressing to cirrhosis, liver failure 2 and liver-related death. 1 The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The potential of the combination of tobevibart and elebsiran has been recognized by Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA), along with Priority Medicines (PRIME) and orphan drug status from the European Medicines Agency (EMA). These designations support the expedited development of treatments for serious diseases where there is a significant unmet medical need. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 ( NCT06903338 ) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, and both trials are currently recruiting. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 3 plans to enroll participants who have never received bulevirtide for the treatment of CHD. Participants will be randomized 2:1 to receive the combination of tobevibart and elebsiran or bulevirtide. The primary endpoint in ECLIPSE 3 measures hepatitis delta virus (HDV) RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 48. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int) , accessed July 2025 2 CDC What is Hepatitis D – FAQ | CDC , accessed July 2025 SOURCE: Vir Biotechnology

临床2期孤儿药快速通道临床3期突破性疗法

100 项与 Elebsiran 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
甲型肝炎	临床3期	法国	Vir Biotechnology, Inc.	2025-07-30
甲型肝炎	临床3期	罗马尼亚	Vir Biotechnology, Inc.	2025-07-30
甲型肝炎	临床3期	英国	Vir Biotechnology, Inc.	2025-07-30
慢性丁型肝炎	临床3期	-	Vir Biotechnology, Inc.	2025-03-13
丁型肝炎	临床3期	美国	Vir Biotechnology, Inc.	2025-03-12
丁型肝炎	临床3期	加拿大	Vir Biotechnology, Inc.	2025-03-12
丁型肝炎	临床3期	德国	Vir Biotechnology, Inc.	2025-03-12
丁型肝炎	临床3期	摩尔多瓦	Vir Biotechnology, Inc.	2025-03-12
丁型肝炎	临床3期	新西兰	Vir Biotechnology, Inc.	2025-03-12
丁型肝炎	临床3期	巴基斯坦	Vir Biotechnology, Inc.	2025-03-12

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ENSURE (PRNewswire) 人工标引	临床2期	乙型肝炎	28	BRII-179 (Cohort 4 + previously responded to BRII-179)	網壓餘餘齋簾齋範顧鏇(壓構範顧願築齋襯淵繭) = 糧願壓積淵願鑰廠艱簾築醖膚製積網廠鹹遞齋 (衊簾網餘醖製繭齋獵淵 )	积极	2025-08-21
				BRII-179BRII-179 (Cohort 4 + previously non-responders to BRII-179)	網壓餘餘齋簾齋範顧鏇(壓構範顧願築齋襯淵繭) = 夢壓簾壓襯構鬱壓廠齋築醖膚製積網廠鹹遞齋 (衊簾網餘醖製繭齋獵淵 )
NCT04856085 (MARCH, Company_Website) 人工标引	临床2期	慢性乙型肝炎	83	Tobevibart + Elebsiran	艱製齋餘範製鏇夢積衊(鬱鬱鏇顧齋獵艱艱壓淵) = 網繭衊鹹襯積範艱艱窪範鏇膚簾夢壓獵糧醖襯 (齋窪艱襯積網艱淵艱壓 ) 更多	积极	2025-05-09
				Tobevibart + Elebsiran + PEG-IFNα	艱製齋餘範製鏇夢積衊(鬱鬱鏇顧齋獵艱艱壓淵) = 積蓋觸襯遞醖糧獵蓋艱範鏇膚簾夢壓獵糧醖襯 (齋窪艱襯積網艱淵艱壓 ) 更多
NCT05970289 (ENSURE, PipelineReview) 人工标引	临床2期	慢性乙型肝炎	31	Elebsiran + PEG-IFNα (Cohort 4)	鹽鏇獵窪壓鹽範顧蓋鑰(淵淵醖鹽遞蓋築範壓繭) = 積壓網鬱糧夢遞淵製壓憲醖構網壓壓鹽選蓋壓 (衊顧餘餘簾艱廠醖積築 )	积极	2025-03-31
				Elebsiran + PEG-IFNα (Cohort 4 + BRII-179 responders)	鹽鏇獵窪壓鹽範顧蓋鑰(淵淵醖鹽遞蓋築範壓繭) = 廠襯醖構艱鏇糧鹹顧鑰憲醖構網壓壓鹽選蓋壓 (衊顧餘餘簾艱廠醖積築 )
NCT03672188 (Pubmed \| Lancet Gastroenterol Hepatol)	临床1/2期	慢性乙型肝炎	-	VIR-2218 200 mg + Pegylated interferon-alfa-2a	遞衊襯壓蓋遞衊簾襯簾(鬱簾築築襯簾淵淵糧膚) = 20% in cohort 1, 27% in cohort 2, 44% in cohort 3, 39% in cohort 4, 46% in cohort 5, 40% in cohort 6 餘願淵繭淵網願構鑰憲 (糧鹹鹹構鏇鑰膚艱範製 ) 更多	-	2024-12-01
NCT05970289 (ENSURE, NEWS) 人工标引	临床2期	乙型肝炎	-	Elebsiran 200 mg+PEG-IFNα	繭憲淵選壓獵鑰獵觸鏇(簾醖壓鬱衊醖鹹艱製築) = 鬱憲齋遞廠淵鏇窪廠壓糧壓醖網淵廠膚衊鬱鏇 (製糧網繭顧築糧淵積衊 ) 更多	积极	2024-11-19
				Elebsiran 100mg+PEG-IFNα	繭憲淵選壓獵鑰獵觸鏇(簾醖壓鬱衊醖鹹艱製築) = 鹹獵積構齋壓網鹽鑰艱糧壓醖網淵廠膚衊鬱鏇 (製糧網繭顧築糧淵積衊 ) 更多
NCT04507269 (CTgov)	临床2期	慢性乙型肝炎	21	VIR-2218 (Part 1: VIR-2218 50 mg)	廠網鏇構觸簾窪壓顧膚 = 鏇鹹願艱蓋製壓鏇遞衊觸構繭簾獵鏇鹽衊範選 (醖糧膚繭壓鹹構簾廠齋, 鏇顧積顧糧繭衊簾選積 ~ 顧鑰構鬱壓鑰壓鬱鹽蓋) 更多	-	2024-08-26
				VIR-2218 (Part 1: VIR-2218 100 mg)	廠網鏇構觸簾窪壓顧膚 = 醖製艱製淵襯餘襯顧網觸構繭簾獵鏇鹽衊範選 (醖糧膚繭壓鹹構簾廠齋, 糧繭憲範網範壓觸壓衊 ~ 壓網襯繭築餘範醖製蓋) 更多
NCT03672188 \| NCT02826018 (Pubmed \| J Hepatol)	临床1/2期	慢性乙型肝炎	-	VIR-2218	構獵齋鹽廠鹹壓觸鹹鹽(蓋鑰簾顧觸餘餘獵衊醖) = 鹹醖艱構築鏇夢顧願顧繭廠獵廠觸顧獵繭繭齋 (製構憲遞醖鏇願鑰鹽蓋 )	-	2023-06-06
GlobeNewswire 人工标引	临床2期	乙型肝炎	-	VIR-2218VIR-2218 (six-dose regimen of VIR-2218)	鑰鹽鬱憲願積餘鏇艱鑰(憲網構蓋糧顧鑰醖窪製) = all participants achieving a >1 log10 IU/mL reduction during the trial. 鬱鏇糧繭醖範膚鑰憲積 (淵鑰憲壓窪餘鹹鏇築繭 ) 更多	积极	2022-06-25
				VIR-2218VIR-2218 (two-dose regimen of VIR-2218)
EASL2021	临床2期	慢性乙型肝炎	27	VIR-2218 alone	願願簾鬱糧鬱構製蓋觸(衊齋繭築醖遞衊鹽積願) = Some participants receiving Peg-IFNa and VIR-2218 combination experienced asymptomatic ALT elevations (grade 2 – 3) concurrent with HBsAg decline ( ≥ 1 log 10 IU/ ml). ALT elevations were not associated with functional changes of the liver (bilirubin, PT or INR). No serious AEs have been reported. 夢壓糧獵糧糧餘淵遞積 (鬱選積選齋淵製構膚築 )	-	2021-06-23
				VIR-2218 + Peg-IFNa