HENDERSON, Nev.--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today shared supportive data from a Phase 1 study evaluating its lead candidate, tibulizumab (ZB-106), for the treatment of Sjogren’s syndrome.

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These data, along with preclinical data supporting further development of tibulizumab in rheumatoid arthritis (RA), were presented at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna..

这些数据以及支持tibulizumab在类风湿性关节炎（RA）中进一步发展的临床前数据已在2024年维也纳欧洲风湿病年会（EULAR）上发表。。

“Collectively, these data add to early-phase evidence demonstrating that dual-inhibition of both IL-17A and BAFF could be a breakthrough approach for autoimmune and inflammatory diseases in which single-pathway inhibition is the standard of care,” stated Robert Lisicki, Chief Executive Officer. “The results in Sjogren’s syndrome demonstrate that tibulizumab achieved robust target engagement, nearing maximum serum levels following single, well-tolerated subcutaneous doses at four-week intervals.

首席执行官罗伯特·利西基（RobertLisicki）表示：“总的来说，这些数据增加了早期证据，证明IL-17A和BAFF的双重抑制可能是自身免疫和炎症性疾病的突破性方法，其中单通路抑制是标准治疗方法。”。“干燥综合征的结果表明，tibulizumab实现了强大的靶向参与，在间隔四周单次耐受性良好的皮下剂量后接近最高血清水平。

Further, the preclinical results suggest dual-pathway inhibition may warrant clinical exploration in RA and other autoimmune diseases, adding to the breadth of potential we see with tibulizumab.”.

此外，临床前结果表明，双途径抑制可能需要在RA和其他自身免疫性疾病中进行临床探索，从而增加了我们在tibulizumab中看到的潜力。”。

Key Findings from Phase 1 Study of Tibulizumab in Sjogren’s Syndrome

干燥综合征Tibulizumab第一阶段研究的主要发现

The randomized, double-blind, placebo-controlled Phase 1 study evaluated four ascending doses of tibulizumab in 25 participants with Sjogren’s syndrome. Twenty-one participants in the 12-week study received ≥1 dose of tibulizumab (30mg Q4W, 100mg Q4W, 300mg Q4W, 300mg Q2W), with four receiving placebo..

这项随机，双盲，安慰剂对照的1期研究评估了25名干燥综合征患者中四种递增剂量的替布利珠单抗。在为期12周的研究中，21名参与者接受了≥1剂的替布利珠单抗（30mg Q4W，100mg Q4W，300mg Q4W，300mg Q2W），其中4名接受了安慰剂。。

Treatment with tibulizumab was generally well tolerated in patients with Sjogren’s syndrome.

干燥综合征患者对替布利珠单抗的治疗通常耐受性良好。

Serum levels of total IL-17A and BAFF increased following tibulizumab administration, reflecting target engagement. At doses of 100 mg Q4W and higher, the total IL-17A and BAFF concentrations appeared to plateau, suggesting the targets were engaged nearly to maximum levels.

tibulizumab给药后血清总IL-17A和BAFF水平升高，反映了靶标参与。在剂量为100 mg Q4W或更高时，总IL-17A和BAFF浓度似乎趋于平稳，表明目标接近最大水平。

Throughout the study, total B cell counts were dose-dependently reduced in all participants, while administration of tibulizumab was associated with lower levels of Th1 cells. Tibulizumab was also shown to modulate inflammatory mediators, including serum amyloid A, interleukins 5 and 10, as well as basic fibroblast growth factor.

。Tibulizumab还显示出调节炎症介质，包括血清淀粉样蛋白A，白细胞介素5和10以及碱性成纤维细胞生长因子。

These reductions suggest tibulizumab has treatment potential for additional autoimmune conditions..

这些减少表明tibulizumab对其他自身免疫性疾病具有治疗潜力。。

The poster is available in the News and Events section on the Zura Bio website and will be archived for at least 30 days following presentation.

该海报可在Zura Bio网站的新闻和事件部分获得，并将在展示后至少存档30天。

Key Findings from Preclinical Study of Tibulizumab in an RA Model

RA模型中替布利珠单抗临床前研究的主要发现

The preclinical study was designed to evaluate the respective and combined benefits of inhibiting IL-17A and BAFF in a mouse model of RA. Mice received IL-17A antibodies and/or BAFF antibodies, or a control antibody.

临床前研究旨在评估在RA小鼠模型中抑制IL-17A和BAFF的各自和综合益处。小鼠接受IL-17A抗体和/或BAFF抗体或对照抗体。

Cumulative clinical disease scores were significantly reduced in mice treated with the combination of anti-IL-17A and anti-BAFF compared to the isotype control (p<0.001); combined IL-17A and BAFF inhibition also resulted in less signs of disease compared to individually targeted treatment.

与同种型对照相比，用抗IL-17A和抗BAFF联合治疗的小鼠的累积临床疾病评分显着降低（p<0.001）；与单独靶向治疗相比，联合IL-17A和BAFF抑制也导致较少的疾病迹象。

Combined IL-17A and BAFF inhibition reduced inflammation significantly compared to the control (p<0.05).

与对照组相比，IL-17A和BAFF联合抑制可显着减轻炎症（p＜0.05）。

Combined IL-17A and BAFF inhibition was associated with a significant reduction of anti-collagen antibodies compared to the control (p<0.01).

与对照组相比，IL-17A和BAFF联合抑制与抗胶原抗体显着降低有关（p＜0.01）。

The study abstract, which was accepted for publication only, is available on the EULAR website.

该研究摘要仅被接受发表，可在EULAR网站上查阅。

ABOUT TIBULIZUMAB

关于TIBULIZUMAB

Tibulizumab, a humanized bispecific dual antagonist antibody, is a fusion of TALTZ® (ixekizumab) and tabalumab that has been 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 hidradenitis suppurativa in Q2-2025.

Tibulizumab是一种人源化双特异性双重拮抗剂抗体，是TALTZ®（ixekizumab）和tabalumab的融合体，已被设计为结合并中和IL-17A和BAFF。预计Tibulizumab将在第4-2024季度进入治疗系统性硬化症的2期临床开发阶段，并在第2-2025季度进入治疗化脓性汗腺炎的2期临床开发阶段。

Completed tibulizumab studies include Phase 1/1b trials in Sjogren’s syndrome and rheumatoid arthritis..

完成的tibulizumab研究包括干燥综合征和类风湿性关节炎的1/1b期试验。。

ABOUT ZURA BIO

关于年龄

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 and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), 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。。该公司正在开发替布利珠单抗（ZB-106），ZB-168和托鲁单抗（ZB-880）的治疗适应症组合，旨在证明其在自身免疫性和炎症性疾病（包括系统性硬化症和其他未满足需求的新适应症）中的疗效，安全性和给药方便性。。

FORWARD-LOOKING STATEMENTS

前瞻性声明

This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook” and similar expressions are intended to identify such forward-looking statements.

该通信包括1995年《私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”。诸如“预期”、“估计”、“项目”、“预算”、“预测”、“预期”、“打算”、“计划”、“可能”、“会”、“可能”、“应该”、“相信”、“预测”、“潜力”、“继续”、“战略”、“未来”、“机会”、“会”、“看起来”、“寻求”、“展望”等词语，以及类似的表述，旨在识别此类前瞻性陈述。

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication.

前瞻性陈述是基于当前预期和假设的关于未来事件的预测、预测和其他陈述，因此，前瞻性陈述受到可能导致实际结果与预期结果产生重大差异的风险和不确定性的影响。这些陈述基于各种假设，无论是否在本通信中确定。

These forward-looking statements in this release include, but are not limited to, statements regarding Zura Bio’s anticipated proceeds to be received in the proposed Private Placement, expected timing of closing of the proposed Private Placement and the size, completion and use of proceeds of the proposed Private Placement, the forecast of cash runway and the Company’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives, statements related to Zura Bio’s abilities to achieve anticipated internal readouts and achieve them in expected time periods, Zura Bio’s product candidates, clinical trials and the design and timing thereof, statements with respect to expected therapeutic potential and statements regarding Zura Bio’s product candidates ability to proceed into Phase 2 clinical trials.

本新闻稿中的这些前瞻性声明包括但不限于关于Zura Bio在拟议私募中预期收益的声明、拟议私募的预期关闭时间以及拟议私募收益的规模、完成和使用情况的声明、现金跑道的预测以及公司对资金、运营和营运资本支出、业务战略和目标的预期、与Zura Bio实现预期内部读数并在预期时间段内实现这些读数的能力相关的声明、Zura Bio的候选产品、临床试验及其设计和时间、与预期治疗潜力相关的声明以及关于Zura Bio候选产品进入第二阶段临床试验的能力的声明。（笑声）。

These forward-looking statements are provided for i.

这些前瞻性声明是为我提供的。

Actual events and the ability to consummate the proposed Private Placement and the timing and proceeds thereof; are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of Zura Bio's 10-K for the year ended December 31, 2023 and other filings with the SEC, including: Zura Bio’s expectations regarding product candidates and their related benefits; Zura Bio’s beliefs regarding potential benefits or limitations of competing products both in development and approved; information regarding Zura Bio’s vision and strategy; anticipated timing of key events and initiation of Zura Bio’s studies and release of clinical data; Zura Bio’s expectations regarding the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; Zura Bio’s ability to attract and retain key personnel; the accuracy of Zura Bio’s future operating expenses, capital requirements and needs for additional financing; Zura Bio’s ability to obtain funding for operations, including funds that may be necessary to complete development of our product candidates; the fact that Zura Bio has not completed any clinical trials and has no products approved for commercial sale; the fact that Zura Bio has incurred significant losses since inception, and it expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio’s ability to renew existing contracts; Zura Bio’s reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio’s ability to obtain regulatory .

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