After a Single Administration of JK07, Patients in All Dose Cohorts Showed Improvement in Ejection Fraction (EF) Through Day 90单次 JK07 给药后，所有剂量队列中的患者在第 90 天的射血分数 (EF) 均有所改善
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JK07 was Generally Safe and Well-ToleratedJK07 一般安全且耐受性良好
JK07 is a First-in-class Antibody Fusion and Selective ErbB4 AgonistJK07 是一流的抗体融合和选择性 ErbB4 激动剂
Company Plans to Initiate Phase 2 Heart Failure Study in the Second Half of 2023公司计划在 2023 年下半年启动 2 期心力衰竭研究
GAITHERSBURG, Md.--(BUSINESS WIRE)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction (HFrEF). The data were presented in a late breaking oral session during the annual congress of the European Society of Cardiology’s Heart Failure Association. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans1.马里兰州盖瑟斯堡--(BUSINESS WIRE)--(美国商业资讯)--致力于发现和开发新型复杂生物疗法的临床阶段生物技术公司 Salubris Biotherapeutics, Inc. (SalubrisBio) 今天宣布了正在进行的 JK07 1b 期研究的积极更新结果射血分数降低的心力衰竭 (HFrEF)。这些数据是在欧洲心脏病学会心力衰竭协会年会期间的最后一次口头会议上公布的。 JK07是第一个进入心力衰竭临床开发的研究性抗体融合蛋白和第一个选择性ErbB4激动剂。心力衰竭是一种严重的健康状况，导致美国八分之一的人死亡，并影响近 650 万美国人 1 。Fourteen patients were randomized 3 to 1 (11 JK07 : 3 placebo), with five patients in each of the first two cohorts (0.03mg/kg and 0.09 mg/kg, respectively), and four in the third cohort (0.27 mg/kg). Single doses were administered intravenously and changes from baseline values of left ventricular EFwere measured for each patient. Results from the study were presented byprincipal investigator Dr. W. H. Wilson Tang, Research Director and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine at the Cleveland Clinic.14 名患者随机分配 3 对 1（11 名 JK07：3 名安慰剂），前两个队列各有 5 名患者（分别为 0.03mg/kg 和 0.09mg/kg），第三组有 4 名患者（0.27mg/kg ).静脉内给予单剂量，并测量每位患者左心室 EF 基线值的变化。研究结果由首席研究员 W. H. Wilson Tang 博士、克利夫兰诊所心力衰竭和心脏移植医学科的研究主任和工作人员心脏病专家介绍。
Key findings include: 主要发现包括：
Robust dose-dependent biomarker changes demonstrated target engagement at all dose levels.强大的剂量依赖性生物标志物变化证明了所有剂量水平的目标参与。
Meaningful changes in LVEF were observed across all dose groups in comparison with placebo:与安慰剂相比，所有剂量组的 LVEF 都发生了有意义的变化：
JK07 has been generally well-tolerated with most adverse events mild to moderate. Only one serious adverse event occurred (Grade 3), at the top dose level.JK07 一般耐受性良好，大多数不良事件为轻度至中度。在最高剂量水平下，仅发生了一起严重不良事件（3 级）。
“Heart failure is a leading cause of morbidity and mortality in the US and globally. These new interim results demonstrate that JK07 achieved robust target engagement and encouraging signs of potential clinical benefit with a single administration,” said Sam Murphy, Chief Executive Officer of SalubrisBio. “The durable and sustained responses observed, coupled with a favorable safety profile, support further investigation of JK07 and we look forward to building upon these findings with the initiation of a Phase 2 trial later this year."“心力衰竭是美国乃至全球发病率和死亡率的主要原因。这些新的中期结果表明，JK07通过单次给药实现了强大的目标参与和令人鼓舞的潜在临床益处迹象，”SalubrisBio 首席执行官 Sam Murphy 说。 “观察到的持久和持续的反应，加上良好的安全性，支持对 JK07 的进一步研究，我们期待在今年晚些时候启动 2 期试验的基础上进一步研究这些发现。”
A double-blind, randomized, repeat-dose Phase 2 trial of JK07 in patients with HF is expected to initiate in the second half of 2023.JK07在心衰患者中的双盲、随机、重复剂量2期试验预计将于2023年下半年启动。
About Heart FailureHeart failure affects an estimated 6.2 million Americans2 and more than 64 million people worldwide3. Heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) each affect over 3 million patients in the US alone. Heart failure is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death. In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly. JK07 is in development for the treatment of both HFrEF and HFpEF.关于心力衰竭心力衰竭影响了估计 620 万美国人 2 和全球超过 6400 万人 3 。射血分数降低的心力衰竭 (HFrEF) 和射血分数保留的心力衰竭 (HFpEF) 仅在美国就影响了超过 300 万患者。心力衰竭是一种慢性疾病，患者会经历逐渐恶化的症状和生活质量、住院和死亡。在 HFrEF 中，左心室失去正常收缩的能力，心脏无法泵出足够的力量将足够的血液推入循环。在 HFpEF 中，心脏变得僵硬并失去正常运作的能力。 JK07正在开发中，用于治疗 HFrEF 和 HFpEF。
About JK07JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor that has shown promising activity in heart failure, but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – ErbB3 and ErbB4. The ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the ErbB3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.关于JK07JK07是一种重组融合蛋白，由全人免疫球蛋白IgG1单克隆抗体和人生长因子神经调节蛋白[NRG-1]的活性多肽片段组成。 NRG-1 是一种经过临床验证的生长因子，在治疗心力衰竭方面表现出良好的活性，但也有不良副作用。研究表明，NRG-1 通过与两种不同的受体——ErbB3 和 ErbB4 的相互作用来诱导信号传导。 ErbB4 通路似乎负责心脏的再生作用，而 ErbB3 通路似乎主要负责重组 NRG-1 的安全性和耐受性限制。通过用抗体融合设计阻断 ErbB3 信号，JK07 选择性地刺激具有良好药代动力学特征的 ErbB4 通路，这有可能显着扩大 NRG-1 的治疗窗口并产生更好的临床效果。
About SalubrisBioSalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases. SalubrisBio was founded in August 2016 as a wholly-owned subsidiary of the China-based pharmaceutical company Shenzhen Salubris Pharmaceuticals Co. Ltd. Headquartered in the US, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment to innovation and expansion into the global market and retains the core philosophy of developing therapeutics for large patient populations with significant unmet needs.关于 SalubrisBioSalubrisBio 是一家临床阶段的生物技术公司，致力于发现和开发用于心血管、肿瘤和神经退行性疾病的复杂生物制剂。 SalubrisBio 成立于 2016 年 8 月，是中国制药公司深圳 Salubris Pharmaceuticals Co. Ltd. 的全资子公司。SalubrisBio 总部位于美国，体现了深圳 Salubris Pharmaceuticals 致力于创新和拓展全球市场，并保留了核心为需求未得到满足的大量患者开发治疗方法的理念。
“Heart failure is a leading cause of morbidity and mortality in the US and globally. These new interim results demonstrate that JK07 achieved robust target engagement and encouraging signs of potential clinical benefit with a single administration”“心力衰竭是美国乃至全球发病率和死亡率的主要原因。这些新的中期结果表明，JK07 通过单次给药实现了强大的目标参与和令人鼓舞的潜在临床益处迹象”
