Bluejay Therapeutics 获得监管许可，启动 BJT-778 治疗慢性乙型肝

StephenW

Bluejay Therapeutics 获得监管许可，启动 BJT-778 治疗慢性乙型肝炎和慢性丁型肝炎的临床研究

发布时间：2022 年 12 月 1 日

加利福尼亚州圣马特奥市，2022 年 12 月 1 日（环球新闻社）——Bluejay Therapeutics 今天宣布，它已获得新西兰药品和医疗器械安全局 (MEDSAFE) 和当地伦理委员会的批准，可以着手进行第一- BJT-778 的人体研究，一种一流的抗乙型肝炎表面抗原（抗 HBsAg mAb）单克隆抗体。 BJT-778 可中和并清除乙型肝炎和丁型肝炎病毒粒子，并消除含有 HBsAg 的亚病毒颗粒，这可能有助于重建受试者的抗病毒免疫力，并有助于慢性乙型肝炎 (CHB) 的功能性治愈。 BJT-778 卓越的临床前安全性和有效性概况使其成为与现有和新兴疗法联合治疗 CHB 和慢性丁型肝炎（CHD）的理想候选药物。随着该试验的开始，Bluejay 已成功转型为一家临床阶段公司。

首席医疗官 Nancy Shulman 博士说：“我们很高兴 BJT-778 将在健康志愿者以及 CHB 和 CHD 受试者中进行评估。 BJT-778 将在单次递增剂量队列中测试安全性和临床疗效，然后在 CHB 和 CHD 受试者中重复给药，这将为评估 BJT-778 作为联合疗法的一部分铺平道路。”

“这是 Bluejay 在运营不到一年半的时间里达到的一个重要里程碑，真实反映了 Bluejay 团队的能力和专业知识。我们期待实现更多这样的里程碑，例如扩大 Bluejay 产品开发管道，用于病毒和肝病的创新疗法和治疗，”Bluejay Therapeutics 创始人兼首席执行官 Keting Chu 博士说。

关于 Bluejay Therapeutics

Bluejay Therapeutics 是一家私营生物制药公司，专注于开发治疗和治愈病毒性和肝病的方法 (www.bluejaytx.com)。公司首个目标适应症为CHB和CHD。 CHB 仍然是一种世界范围内流行的疾病，医疗需求未得到满足。冠心病与癌症一样，是一种发病率和死亡率都很高的疾病，在美国还没有FDA批准的治疗方法。 Bluejay 正在推进两种具有高功能治愈率潜力的方法：一流的全人 IgG1 抗 HBs 单克隆抗体和口服生物可利用的肝靶向 HBV 转录物抑制剂。最近，Bluejay 开发了一个肝脏定向药物靶向平台，该平台将适用于多种治疗药物。要了解更多关于与 Bluejay Therapeutics 就合作机会、临床前或临床研究项目进行合作的可能性，请通过 [email protected] 联系我们

StephenW

Bluejay Therapeutics Received Regulatory Clearance to Initiate Clinical Studies of BJT-778 for Treatment of Chronic Hepatitis B and Chronic Hepatitis D

Published: Dec 01, 2022

SAN MATEO, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Bluejay Therapeutics announced today that it received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) and from the local Ethics Committee to proceed with a first-in-human study of BJT-778, a best-in-class monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb). BJT-778 neutralizes and clears hepatitis B and hepatitis D virions and depletes HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for chronic hepatitis B (CHB). BJT-778’s remarkable preclinical safety and efficacy profiles make it an ideal candidate for combination therapies with existing and emerging therapies for CHB and chronic hepatitis D (CHD). With the commencement of this trial, Bluejay has successfully transitioned into a clinical stage company.

Dr. Nancy Shulman, Chief Medical Officer, said, “We’re excited that BJT-778 will be evaluated in healthy volunteers and in subjects with CHB and CHD. BJT-778 will be tested for safety and clinical efficacy in single ascending dose cohorts, followed by repeated doses in CHB and CHD subjects that will pave the way to evaluate BJT-778 as a part of combination therapies.”

“This is a significant milestone for Bluejay to reach in less than one and a half years since beginning of operations, a true reflection of the capability and expertise of Bluejay team. We look forward to achieving more milestones like this, such as growing the Bluejay product development pipeline for innovative cures and treatments of viral and liver diseases,” said Dr. Keting Chu, founder and CEO of Bluejay Therapeutics.

About Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatment and cures for viral and liver diseases (www.bluejaytx.com). The company’s first target indications are CHB and CHD. CHB remains a worldwide prevalent disease with urgent unmet medical need. CHD is a disease with high rate of morbidity and mortality like cancer, and no FDA approved therapy in the US. Bluejay is advancing two approaches with the potential for high rates of functional cure: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally bioavailable liver-targeted HBV transcript inhibitors. Most recently, Bluejay has developed a platform for liver-directed drug targeting that will be applicable to multiple therapeutic agents. To learn more about the potential to collaborate with Bluejay Therapeutics on partnering opportunities, preclinical or clinical research programs, please contact us at [email protected].

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