SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.

加利福尼亚州圣马特奥，2024年3月25日（环球通讯社）--Bluejay Therapeutics，Inc.，一家专注于病毒和肝病的私人临床阶段生物制药公司，今天宣布欧洲药品管理局（EMA）已授予BJT-778优先药物（PRIME）名称，用于治疗慢性肝炎三角洲病毒（HDV）感染。

BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions. The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company's Phase 1/2 study that included subjects with chronic HDV..

BJT-778是一种高效，全人免疫球蛋白G1（IgG1）mAb，通过中和和促进HDV病毒粒子的清除而对HDV起到抗病毒作用。来自非临床研究的令人信服的数据，以及该公司1/2期研究（包括慢性HDV受试者）的中期结果，支持了初步指定的申请。

“We are grateful for EMA’s decision to grant PRIME designation to BJT-778 for treatment of chronic HDV, affirming its potential to fulfill the unmet medical need as a new therapeutic option for this severe disease. This will accelerate our development process to provide a well-tolerated and efficacious treatment for patients globally and save lives,” said Keting Chu, Chief Executive Officer at Bluejay.

Bluejay首席执行官Keting Chu表示：“我们非常感谢EMA决定授予BJT-778治疗慢性HDV的最佳称号，确认其有潜力满足未满足的医疗需求，作为这种严重疾病的新治疗选择。这将加速我们的发展进程，为全球患者提供耐受性良好且有效的治疗，挽救生命。”

“We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”.

“我们热切期望与EMA和其他监管机构继续合作，以加速为患者提供这种有希望的治疗方法。”

About Bluejay Therapeutics

关于Bluejay Therapeutics

Bluejay Therapeutics is a private biopharmaceutical company focused on the development of treatments for viral and liver diseases. The Company’s lead program, BJT-778 is a potentially best-in-class fully human IgG1 monoclonal antibody against hepatitis B surface antigen (anti-HBsAg mAb), being developed for both chronic HBV and HDV.

Bluejay Therapeutics是一家私营生物制药公司，专注于病毒和肝病治疗的开发。该公司的主导项目BJT-778是一种潜在的同类最佳的抗乙型肝炎表面抗原（抗HBsAg mAb）的全人IgG1单克隆抗体，正在为慢性HBV和HDV开发。

BJT-778 is designed to provide anti-HBV and anti-HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg-containing subviral particles, which may help to reconstitute a subject’s antiviral immunity and contribute to functional cure for CHB. Bluejay is also developing and advancing other innovative programs for chronic HBV, including a proprietary TLR9 agonist (Cavrotolimod) and a liver targeted transcript inhibitor (BJT-628), with the goal of achieving higher rates of functional cure.

BJT-778旨在通过中和和清除HBV和HDV病毒粒子以及消耗含HBsAg的亚病毒颗粒来提供抗HBV和抗HDV的益处，这可能有助于重建受试者的抗病毒免疫力，并有助于CHB的功能性治疗。Bluejay还正在开发和推进其他针对慢性HBV的创新项目，包括专有的TLR9激动剂（Cavrotolimod）和肝靶向转录抑制剂（BJT-628），目的是实现更高的功能治愈率。

For more information on Bluejay, please visit the company’s website at www.bluejaytx.com..

有关Bluejay的更多信息，请访问公司网站www.bluejaytx.com。