HENDERSON, Nev.--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced the submission of a protocol to its open Investigational New Drug (IND) application with the U.S.

内华达州亨德森（商业新闻短讯）--Zura Bio Limited（纳斯达克：Zura）（“Zura Bio”）是一家临床阶段的多资产免疫学公司，开发针对自身免疫性和炎性疾病的新型双途径抗体，今天宣布向美国提交其开放性研究新药（IND）申请的协议。

Food and Drug Administration (FDA) for a Phase 2 study evaluating tibulizumab, a humanized tetravalent bispecific dual antagonist antibody designed to neutralize both IL-17A and BAFF, for the treatment of systemic sclerosis (SSc) in adults..

美国食品和药物管理局（FDA）进行了一项2期研究，评估tibulizumab，一种人源化四价双特异性双重拮抗剂抗体，旨在中和IL-17A和BAFF，用于治疗成人系统性硬化症（SSc）。。

“Systemic sclerosis presents significant unmet needs, as current treatments largely target only its interstitial lung disease (ILD) component,” said Robert Lisicki, CEO of Zura Bio. “Tibulizumab, with dual IL-17A and BAFF inhibition, offers a potential first-in-class approach addressing both immune dysregulation and fibrosis—key drivers of the disease.

Zura Bio首席执行官罗伯特·利西基（RobertLisicki）说：“系统性硬化症提出了大量未满足的需求，因为目前的治疗主要针对其间质性肺病（ILD）成分。具有双重IL-17A和BAFF抑制作用的Tibulizumab提供了一种潜在的一流方法，可以解决免疫失调和纤维化疾病的关键驱动因素。

This study protocol reflects our commitment to advancing therapies that could potentially bring meaningful improvements for those affected by systemic sclerosis.”.

这项研究方案反映了我们对推进治疗的承诺，这些治疗可能会为受系统性硬化症影响的患者带来有意义的改善。”。

The planned Phase 2 clinical trial, a double-blind, randomized (1:1), placebo-controlled study, is designed to evaluate the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis (dcSSc). The anticipated study aims to demonstrate improvements in skin and lung symptoms, two primary complications of SSc, and includes an open-label extension.

计划的2期临床试验是一项双盲，随机（1:1）安慰剂对照研究，旨在评估替布利珠单抗在大约80名早期弥漫性皮肤系统性硬化症（dcSSc）患者中的安全性，耐受性和有效性。预期的研究旨在证明皮肤和肺部症状的改善，SSc的两个主要并发症，并包括开放标签的扩展。

The trial is expected to initiate in Q4 2024, with an Orphan Drug Designation request already submitted to the FDA in the same quarter..

该试验预计将于2024年第四季度开始，同一季度已向FDA提交孤儿药指定申请。。

Tibulizumab has not received approval from any regulatory authority, and its safety and efficacy for the treatment of SSc have not been established.

Tibulizumab尚未获得任何监管机构的批准，其治疗SSc的安全性和有效性尚未确定。

ABOUT SYSTEMIC SCLEROSIS

关于系统性硬化症

Systemic sclerosis (SSc), also known as scleroderma, is a rare, life-threatening autoimmune disease affecting approximately 300,000 individuals worldwide, including around 100,000 in the United States. Characterized by chronic inflammation and progressive fibrosis of connective tissues, SSc primarily affects the skin and lungs but can also impact the heart, liver, kidneys, digestive tract, and vascular system.

系统性硬化症（SSc），也称为硬皮病，是一种罕见的威胁生命的自身免疫性疾病，影响全世界约30万人，其中包括美国约10万人。SSc以结缔组织的慢性炎症和进行性纤维化为特征，主要影响皮肤和肺部，但也可能影响心脏，肝脏，肾脏，消化道和血管系统。

The most common symptoms of SSc include skin thickening and extreme sensitivity to cold in the extremities. The disease can also affect other organs and tissues, leading to muscle numbness and swelling, joint stiffness and reduced mobility, fibrosis in the lungs and heart, kidney dysfunction, and gastrointestinal issues such as difficulty swallowing, heartburn, bloating, constipation, and diarrhea..

SSc最常见的症状包括皮肤增厚和四肢对寒冷极为敏感。该疾病还可能影响其他器官和组织，导致肌肉麻木和肿胀，关节僵硬和活动能力下降，肺和心脏纤维化，肾功能障碍以及吞咽困难，胃灼热，腹胀，便秘和腹泻等胃肠道问题。。

There remains a high unmet medical need due to the limited treatment options available for individuals living with SSc. Currently, only two disease-modifying therapies are FDA-approved for severe lung complications of the disease (i.e., SSc-ILD), and no effective treatment exists that addresses the disease across multiple organ systems..

由于SSc患者的治疗选择有限，医疗需求仍未得到满足。目前，只有两种疾病缓解疗法被FDA批准用于该疾病的严重肺部并发症（即SSc-ILD），并且没有有效的治疗方法可以解决多器官系统的疾病。。

ABOUT TIBULIZUMAB

关于替布利珠单抗

Tibulizumab, an investigational humanized, tetravalent bispecific dual-antagonist antibody, is a fusion of Taltz® (ixekizumab) and tabalumab, engineered to bind to and neutralize both IL-17A and BAFF. Tibulizumab is expected to enter Phase 2 clinical development for the treatment of systemic sclerosis in Q4 2024 and for the treatment of hidradenitis suppurativa in Q2 2025.

Tibulizumab是一种研究性人源化四价双特异性双重拮抗剂抗体，是Taltz®（ixekizumab）和tabalumab的融合体，经过工程改造可结合并中和IL-17A和BAFF。预计Tibulizumab将于2024年第4季度进入治疗系统性硬化症的2期临床开发阶段，并于2025年第2季度进入治疗化脓性汗腺炎的2期临床开发阶段。

Before in-licensing, Phase 1/1b studies of tibulizumab were conducted in Sjögren’s syndrome and rheumatoid arthritis..

在获得许可之前，在干燥综合征和类风湿性关节炎中进行了tibulizumab的1/1b期研究。。

ABOUT ZURA BIO

关于ZURA BIO

Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), crebankitug (ZB-168), and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs..

Zura Bio是一家临床阶段的多资产免疫学公司，开发用于自身免疫和炎症性疾病的新型双途径抗体。目前，Zura Bio正在开发三项资产，这些资产已完成1/1b期研究。该公司正在开发替布利珠单抗（ZB-106），crebankitug（ZB-168）和torudokimab（ZB-880）的治疗适应症组合，目的是证明其在自身免疫和炎症性疾病中的疗效，安全性和给药方便性，包括系统性硬化症和其他未满足需求的新适应症。。