SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced key clinical development updates.

加利福尼亚州南旧金山（商业新闻短讯）--Kezar Life Sciences，Inc.（纳斯达克：KZR），一家临床阶段的生物技术公司，开发新型小分子疗法，以治疗免疫介导疾病的未满足需求，今天宣布了关键的临床开发更新。

The IDMC overseeing the PORTOLA Phase 2a clinical trial of zetomipzomib in patients with AIH recommended that the trial may proceed without modification following its third scheduled meeting. The IDMC examined safety data from all patients enrolled in the trial, including data from patients who completed the blinded treatment period and continued to the open-label extension portion of the trial which includes an additional 24 weeks of treatment.

IDMC监督zetomipzomib在AIH患者中的PORTOLA 2a期临床试验，建议该试验在第三次预定会议后无需修改即可进行。IDMC检查了参加试验的所有患者的安全性数据，包括完成盲法治疗期并继续进行试验的开放标签延长部分（包括额外的24周治疗）的患者的数据。

Three members of the IDMC, including the committee chair, are also members of the IDMC overseeing the PALIZADE study of zetomipzomib in LN. To date, no Grade 4 or 5 serious adverse events (SAEs) have been observed in the PORTOLA trial which is being conducted at clinical sites in the United States. Kezar has completed enrollment of PORTOLA and plans to report topline data in the first half of 2025..

IDMC的三名成员，包括委员会主席，也是IDMC的成员，负责监督LN中zetomipzomib的PALIZADE研究。迄今为止，在美国临床地点进行的PORTOLA试验中未观察到4级或5级严重不良事件（SAE）。Kezar已完成PORTOLA的注册，并计划在2025年上半年报告topline数据。。

Kezar has also made the strategic decision to terminate the PALIZADE Phase 2b clinical trial in patients with active LN and focus clinical development efforts of zetomipzomib in AIH, a rare disease with a significant unmet medical need. PALIZADE was recently placed on clinical hold following the recommendation of the IDMC after its assessment of four Grade 5 (fatal) SAEs that occurred in patients enrolled in the Philippines and Argentina (including one patient on placebo).

Kezar还做出了战略决定，终止活动性LN患者的PALIZADE 2b期临床试验，并将zetomipzomib的临床开发工作重点放在AIH中，AIH是一种罕见疾病，医疗需求严重未得到满足。在IDMC对菲律宾和阿根廷入选患者（包括一名服用安慰剂的患者）发生的四种5级（致命）SAE进行评估后，PALIZADE最近被临床搁置。

Kezar will unblind the trial and perform a full investigation into all safety events from the study. As of termination, 84 patients were enrolled, and Kezar will report available data from PALIZADE at a later date..

Kezar将揭盲试验，并对研究中的所有安全事件进行全面调查。截至终止时，共有84名患者入选，Kezar将在晚些时候报告PALIZADE的可用数据。。

“The IDMC recommendation to continue the PORTOLA trial without modification strengthens our confidence in the potential for zetomipzomib to be a meaningful treatment for patients living with autoimmune hepatitis,” said Chris Kirk, PhD, Kezar’s Chief Executive Officer. “While we are disappointed to discontinue our development program in LN, we would like to thank the investigators, patients and their families for their participation in the PALIZADE trial.

Kezar首席执行官Chris Kirk博士说：“IDMC建议不加修改地继续进行PORTOLA试验，这增强了我们对zetomipzomib可能成为自身免疫性肝炎患者有意义的治疗方法的信心。”。“虽然我们对停止LN的发展计划感到失望，但我们要感谢调查人员，患者及其家属参与PALIZADE试验。

This decision was difficult given the favorable safety profile and clinical activity data we have presented from the MISSION study and rapid enrollment to PALIZADE. However, a focused development effort in AIH extends our cash runway and provides flexibility as we work to bring zetomipzomib forward as a treatment for patients living with this life-threatening disease.”.

鉴于我们从任务研究中提供的有利安全性和临床活动数据以及PALIZADE的快速注册，这一决定很难做出。然而，AIH的重点开发工作扩展了我们的现金跑道，并提供了灵活性，因为我们致力于将zetomipzomib作为这种威胁生命的疾病患者的治疗方法。”。

Kezar’s unaudited cash position is approximately $148 million, including cash, cash equivalents and marketable securities, as of September 30, 2024. This cash estimate is a preliminary estimate and based on information currently available to management, and this estimate could change.

截至2024年9月30日，凯撒未经审计的现金头寸约为1.48亿美元，包括现金、现金等价物和有价证券。该现金估算为初步估算，基于管理层目前可获得的信息，该估算可能会发生变化。

About PORTOLA

关于PORTOLA

PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. The study has completed enrollment of 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper.

PORTOLA是一项安慰剂对照，随机，双盲2a期临床试验，评估zetomipzomib对AIH患者的疗效和安全性，这些患者对标准治疗反应不足或复发。这项研究已经完成了24名患者的登记，随机（2:1）接受60毫克zetomipzomib或安慰剂，除了背景治疗24周，方案建议类固醇减量。

The primary efficacy endpoint will measure the proportion of patients who achieve a complete biochemical response by Week 24 measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline..

主要疗效终点将测量在第24周达到完全生化反应的患者比例，测量为丙氨酸氨基转移酶（ALT），天冬氨酸氨基转移酶（AST）和免疫球蛋白G（IgG）值的正常化（如果在基线时升高），类固醇剂量水平不高于基线。。

About Autoimmune Hepatitis

关于自身免疫性肝炎

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma.

自身免疫性肝炎（AIH）是一种罕见的慢性疾病，其中免疫系统攻击肝脏并引起炎症和组织损伤，严重影响患者的身体健康和生活质量。需要终身维持治疗以避免复发和繁重的不良反应。如果不及时治疗，AIH可能导致肝硬化，肝衰竭和肝细胞癌。

In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts.

在美国，AIH影响大约140000人，发病率上升。。目前，AIH的标准治疗方法是使用皮质类固醇进行慢性免疫抑制治疗，皮质类固醇经常引起改变生活的副作用，包括糖尿病，骨质疏松性骨折和白内障。

There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids..

迫切需要减少或消除使用皮质类固醇对慢性免疫抑制的需求的治疗方案。。

About Kezar Life Sciences

关于凯撒生命科学

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.

Kezar Life Sciences是一家临床阶段的生物制药公司，开发新型小分子疗法，以治疗免疫介导疾病中未满足的需求。有关更多信息，请访问www.kezarlifsciences.com，并在LinkedIn、Facebook、Twitter和Instagram上关注我们。

Cautionary Note on Forward-looking Statements

关于前瞻性陈述的警示说明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “plans,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。诸如“可能”、“将”、“可以”、“应该”、“期望”、“相信”、“计划”、“潜在”、“预期”等词语和类似表达（以及其他涉及未来事件、条件或情况的词语或表达）旨在识别前瞻性陈述。

These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s future results or performance to differ materially from those expressed or implied by the forward-looking statements.

这些前瞻性声明基于Kezar截至本新闻稿发布之日的预期和假设。这些前瞻性陈述中的每一项都涉及风险和不确定性，这些风险和不确定性可能导致凯撒未来的业绩或表现与前瞻性陈述中明示或暗示的结果或表现存在重大差异。

Forward-looking statements contained in this press release include, but are not limited to, statements about the nature, frequency and severity of adverse events; the design, progress and outcome of Kezar’s clinical trials; Kezar’s ability to report data from its clinical trials on expected timelines, if at all; and Kezar’s ability to extend its cash runway.

本新闻稿中包含的前瞻性声明包括但不限于关于不良事件的性质、频率和严重程度的声明；Kezar临床试验的设计，进展和结果；Kezar能够在预期的时间表上报告其临床试验数据（如果有的话）；以及凯撒扩大其现金跑道的能力。

Many factors may cause differences between current expectations and actual results, including those factors that are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available..

许多因素可能会导致当前预期与实际结果之间的差异，包括Kezar向美国证券交易委员会提交的文件中讨论的因素，包括其中包含的“风险因素”。除法律要求外，Kezar没有义务更新本文所含的任何前瞻性声明，以反映预期的任何变化，即使有新信息可用。。