Brelovitug(Brelovitug) - 药物靶点：HBsAg_在研适应症：慢性丁型肝炎，慢性乙型肝炎_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

BJT 778、BJT-778、BJT778

靶点

HBsAg

作用方式

抑制剂

作用机制

HBsAg抑制剂(HBV表面抗原抑制剂)

治疗领域

感染消化系统疾病其他疾病

在研适应症

慢性丁型肝炎慢性乙型肝炎

非在研适应症-

原研机构

Novartis AG

在研机构

Bluejay Therapeutics, Inc.初创企业

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)、优先药物（PRIME） (欧盟)

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关联

5

项与 Brelovitug 相关的临床试验

NCT06907290

/ Recruiting临床2/3期

A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

开始日期2025-03-25

申办/合作机构

Bluejay Therapeutics, Inc.初创企业

ACTRN12623000111673

/ Not yet recruiting临床2期

A Phase 1/2a, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection- Part 4 conducted in individuals with chronic hepatitis B infection.

开始日期2023-09-11

申办/合作机构

Bluejay Therapeutics, Inc.初创企业

ACTRN12623000105640

/ Recruiting临床1/2期

A Phase 1/2a, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection - Part 3 conducted in individuals with chronic hepatitis B and D co-infection.

开始日期2023-05-20

申办/合作机构

Bluejay Therapeutics, Inc.初创企业

100 项与 Brelovitug 相关的临床结果

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100 项与 Brelovitug 相关的转化医学

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100 项与 Brelovitug 相关的专利（医药）

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26

项与 Brelovitug 相关的新闻（医药）

2025-03-26

·PipelineReview

Bluejay Therapeutics Announces First Patient Dosed in AZURE-1 Global Pivotal Clinical Trial Evaluating Brelovitug (BJT-778) as a Monotherapy Treatment for Chronic Hepatitis D

AZURE-1 will evaluate the efficacy and safety of brelovitug compared to delayed treatment REDWOOD CITY, CA, USA I March 26, 2025 I Bluejay Therapeutics , a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that the first patient has been dosed in its AZURE-1 global pivotal clinical trial evaluating brelovitug (also known as BJT-778) for the treatment of chronic hepatitis D (CHD). Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus (HDV) and the hepatitis B virus (HBV). “CHD is the most severe form of viral hepatitis with rapid progression to cirrhosis, liver failure and liver cancer. There are currently limited treatment options for CHD, with no therapy approved by the U.S. FDA,” said Nancy Shulman, M.D., Chief Medical Officer of Bluejay Therapeutics. “The initiation of our AZURE-1 pivotal clinical trial is a critical step toward addressing the unmet medical needs of people living with CHD. We plan to recruit and complete this trial as rapidly as possible.” AZURE-1 is a global, randomized, controlled study of brelovitug as a monotherapy for adults living with CHD compared to delayed treatment. This study is being conducted in the United States and other countries around the world. The trial is powered to detect superiority of brelovitug treatment compared with delayed treatment. “Dosing the first patient in AZURE-1 marks a significant milestone in our efforts to develop potentially life-changing treatments for people impacted by viral hepatitis,” said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. “We are committed to advancing brelovitug toward regulatory approvals across the globe.” Phase 2 data for brelovitug in CHD were presented at The Liver Meeting ® 2024 of the American Association for the Study of Liver Diseases (AASLD), demonstrating that brelovitug achieved 100% virologic response across all dose arms and up to 78% combined virologic response and ALT normalization as a monotherapy in participants with CHD. In January 2025, brelovitug received FDA Breakthrough Therapy designation for the treatment of CHD. It has also received PRIME and Orphan designations from the European Medicines Agency. About Brelovitug (also known as BJT-778 ) Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives brelovitug a potentially advantageous safety profile and makes it a potentially efficacious treatment for CHD, a condition with urgent unmet medical need. In addition, brelovitug has shown immunomodulatory functions in chronic hepatitis B (CHB) patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. Bluejay Therapeutics owns the worldwide rights to brelovitug. About Chronic Hepatitis D (CHD) CHD is the most severe form of viral hepatitis due to the potential for rapid progression to liver cirrhosis, liver cancer and liver-related death. CHD affects approximately 7 million people globally. It is estimated that more than 50% of individuals with CHD will die of liver-related causes within 10 years of diagnosis. There are currently no approved treatments for CHD in the United States and most countries worldwide. About Bluejay Therapeutics Bluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug for the treatment of CHD and CHB viral infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted HBV transcript inhibitor (BJT-628). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn . SOURCE: Bluejay Therapeutics

突破性疗法临床结果临床2期孤儿药

2025-01-22

·药明康德

100%患者获得缓解！慢性肝炎药物获FDA突破性疗法认定

▎药明康德内容团队编辑 Bluejay Therapeutics公司今日宣布，其主打候选药物brelovitug（也称为BJT-778）已获得美国FDA授予的突破性疗法认定，用于治疗慢性丁型肝炎（CHD）。目前，全球大多数国家和地区尚无批准用于治疗慢性丁型肝炎的药物。 Brelovitug是一种高效的全人源化免疫球蛋白G1（IgG1）单克隆抗体，靶向乙肝病毒表面抗原（HBsAg）。它旨在中和并清除乙型和丁型肝炎病毒颗粒，同时去除含HBsAg的亚病毒颗粒，这使其成为一种安全且高度有效的CHD治疗选择。此外，brelovitug还在慢性乙型肝炎（CHB）患者中表现出免疫调节功能，它可能通过与其他药物联合使用，帮助恢复抗病毒免疫并促成CHB的功能性治愈。在2024美国肝病研究协会（AASLD）肝脏大会上公布的2期临床试验结果显示，brelovitug在所有剂量组中均实现了100%的病毒学缓解，并且多达78%的参与者达到了病毒学缓解和丙氨酸氨基转移酶（ALT）水平正常化的复合终点。所有剂量组中均观察到丁型肝炎病毒水平和ALT水平的平行下降，这表明通过降低病毒载量对肝脏炎症具有有益效果。 CHD是一种由丁型肝炎病毒引起的慢性进展性肝病，是最严重的慢性病毒性肝炎类型之一。只有乙肝病毒感染者才会被丁肝病毒感染，同时丁肝病毒的复制依赖HBsAg的存在。CHD会增加肝癌的风险，并加速发展为肝硬化和肝功能衰竭，通常在感染后5年内发生。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Bluejay Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for Brelovitug (BJT-778) for the Treatment of Chronic Hepatitis Delta. Retrieved January 21, 2025, from https://www.globenewswire.com/news-release/2025/01/21/3012666/0/en/Bluejay-Therapeutics-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-Brelovitug-BJT-778-for-the-Treatment-of-Chronic-Hepatitis-Delta.html [2] Bluejay Therapeutics Reports Best-in-Class Monoclonal Antibody BJT-778 Achieved 100% Virologic Response and Up To 78% Combined Virologic Response and ALT Normalization as Monotherapy in Participants With Chronic Hepatitis D (CHD). Retrieved January 21, 2025, from https://bluejaytx.com/bluejay-therapeutics-reports-best-in-class-monoclonal-antibody-bjt-778-achieved-100-virologic-response-and-up-to-78-combined-virologic-response-and-alt-normalization-as-m/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期突破性疗法临床结果

2025-01-22

·Pharmaceutical Technology

FDA breakthrough status for Bluejay’s CHD therapy brelovitug

BJT-778 targets the hepatitis B virus surface antigen. Credit: Orawan Pattarawimonchai/Shutterstock. The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bluejay Therapeutics’ fully human immunoglobulin G1 (IgG1) monoclonal antibody, brelovitug, to treat chronic hepatitis delta (CHD). Also referred to as BJT-778, brelovitug targets the hepatitis B virus’ surface antigen. The antibody neutralises and eliminates hepatitis B and D virions, as well as depleting HBsAg-containing subviral particles, making it a safe treatment alternative for the condition. By demonstrating immunomodulatory functions in chronic hepatitis B (CHB) individuals, brelovitug aids in rebuilding antiviral immunity. This could contribute to a functional cure for CHB when used along with other therapeutic agents. The company is currently investigating brelovitug for the treatment of both CHD and chronic hepatitis B virus infections. It previously gained orphan and PRIME designation from the European Medicines Agency (EMA). There are no currently approved treatments for CHD in most nations worldwide as well as in the US. Bluejay Therapeutics founder and CEO Keting Chu stated: “Chronic hepatitis delta is the most aggressive form of viral hepatitis and the lack of approved treatments in the US creates a major unmet need for patients. “Breakthrough therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We look forward to initiating a global pivotal trial as soon as possible to meet our goal of improving patients’ lives.” The company develops treatments for serious viral and liver conditions. It is advancing programmes including a TLR9 agonist, cavrotolimod, and a liver-targeted HBV transcript inhibitor, BJT-628, to develop a combination regimen that delivers a functional cure for CHB. In June 2024, the company released positive preliminary data from a Phase II trial of brelovitug for the treatment of CHD.

突破性疗法临床2期临床结果孤儿药

100 项与 Brelovitug 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性丁型肝炎	临床3期	美国	Bluejay Therapeutics, Inc.初创企业	2025-03-25
慢性乙型肝炎	临床2期	澳大利亚	Bluejay Therapeutics, Inc.初创企业	2023-02-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ACTRN12623000105640 (BJT778-001, GlobeNewswire) 人工标引	临床2期	慢性丁型肝炎	-	BJT-778 300 mg weekly	醖願艱築觸餘鏇願積願(鏇醖積餘築艱糧餘憲窪) = 艱簾鑰淵艱鹹獵鑰願鹹鑰積願醖糧艱窪鏇築範 (艱選築糧憲膚製壓膚鬱 ) 更多	积极	2024-11-15
				BJT-778 600 mg Q2W	醖願艱築觸餘鏇願積願(鏇醖積餘築艱糧餘憲窪) = 窪蓋願廠衊製鏇範膚糧鑰積願醖糧艱窪鏇築範 (艱選築糧憲膚製壓膚鬱 ) 更多
ACTRN12623000111673 (Biospace) 人工标引	临床2期	慢性丁型肝炎	31	BJT-778BJT-778 300 mg	壓範鏇製築選願願遞鹽(淵夢築簾醖選範獵窪衊) = 鏇鏇醖鬱願觸窪襯夢觸鑰襯獵憲選壓願鏇簾糧 (遞糧憲製獵鏇鏇齋襯餘 ) 更多	积极	2024-06-05
				BJT-778BJT-778 600 mg	壓範鏇製築選願願遞鹽(淵夢築簾醖選範獵窪衊) = 醖積窪觸襯築艱獵壓廠鑰襯獵憲選壓願鏇簾糧 (遞糧憲製獵鏇鏇齋襯餘 ) 更多
BJT-778-001 (EASL2024 \| Corporate Publications) 人工标引	临床1期	-	24	BJT-778 75 mg, 300 mg, or 900 mg	鏇鏇網積願觸廠糧淵淵(齋網淵鬱鏇鹹鏇窪憲遞) = 築選網壓築網鑰鬱簾廠糧觸夢簾築構製鏇齋繭 (夢簾積簾構遞鹽範淵餘 ) 更多	积极	2024-06-05
				Placebo	-
ACTRN12623000111673 (BJT-778-001, EASL2024) 人工标引	临床2期	慢性乙型肝炎 \| 慢性丁型肝炎	21	BJT-778 300 mg SC once weekly (QW)	壓積獵簾網遞獵夢窪構(鹽襯醖獵壓顧觸齋襯糧) = 糧鬱網壓窪鹽獵夢膚觸願網製夢蓋齋鏇壓衊窪 (夢窪齋願繭膚繭襯襯網 ) 更多	积极	2024-05-12
				BJT-778 600 mg SC QW for 12 weeks followed by Q2W	-
ACTRN12623000075684 (BJT-778-001, Company_Website) 人工标引	临床1期	慢性乙型肝炎 \| 慢性丁型肝炎	-	BJT-778	糧憲鏇鏇製壓顧壓鑰鏇(製積餘鏇鏇鏇製憲鬱糧) = None 顧壓醖築鏇簾範壓襯觸 (網繭顧壓願積壓鬱窪餘 )	积极	2023-06-01
				Placebo