BOSTON--(

波士顿--(

BUSINESS WIRE

商业热线

)--

)--

Astria Therapeutics, Inc.

阿斯特里亚治疗公司。

(NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced its planned design of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people with hereditary angioedema (HAE), which will include both every 3- (Q3M) and every 6-month (Q6M) treatment arms with the primary analysis at 6 months.

。

Global start-up activities are underway, and ALPHA-ORBIT is expected to initiate in Q1 2025, with top-line results anticipated in early 2027..

全球启动活动正在进行中，ALPHA-ORBIT预计将于2025年第1季度启动，预计2027年初取得最佳结果。。

“We are thrilled to announce our planned Phase 3 design, which reflects feedback from regulators and is intended to support global registration for both Q3M and Q6M administration,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria. “With navenibart, we are pioneering patient-centric dosing flexibility in HAE with the goal of maximizing attack rate reduction with a compellingly low burden of treatment.

Astria首席执行官JillC.Milne博士说：“我们很高兴宣布我们计划的第三阶段设计，该设计反映了监管机构的反馈，旨在支持Q3M和Q6M管理的全球注册。”与navenibart一起，我们在HAE中开创了以患者为中心的剂量灵活性，目标是在极低的治疗负担下最大限度地降低发病率。

Assuming approval, we believe navenibart will become the market-leading, first-choice therapy for HAE.”.

如果获得批准，我们相信navenibart将成为HAE的市场领先的首选疗法。”。

“Our Phase 3 program was designed in collaboration with the patient community and physicians, is based on input from global regulatory authorities, and addresses the importance of providing options to patients for a disease that’s highly variable,” said Christopher Morabito, M.D., Chief Medical Officer at Astria.

Astria首席医疗官克里斯托弗·莫拉比托（ChristopherMorabito）医学博士说：“我们的第三阶段计划是与患者社区和医生合作设计的，基于全球监管机构的投入，并强调了为患者提供高度可变疾病选择的重要性。”。

“Phase 3 preparations are underway, with trial initiation on-track and expected for this quarter. We are driven by the goal of bringing a potentially life-changing therapy to patients with HAE.”.

“第三阶段的准备工作正在进行中，试验正在进行中，预计将在本季度进行。我们的目标是为HAE患者带来一种潜在的改变生命的疗法。”。

ALPHA-ORBIT is designed as a global, randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate the efficacy and safety of navenibart over a 6-month treatment period in up to 145 patients with Type 1 or Type 2 HAE. Patients will be randomized to receive one of three navenibart dose arms: 1) an initial 600 mg dose and followed by 300 mg Q3M, 2) 600 mg Q6M, and 3) 600 mg Q3M, or placebo.

ALPHA-ORBIT是一项全球性、随机、双盲、安慰剂对照的3期关键临床试验，旨在评估145例1型或2型HAE患者在6个月治疗期间纳维尼巴特的疗效和安全性。患者将被随机分配接受三种navenibart剂量组之一：1）初始600 mg剂量，然后是300 mg Q3M，2）600 mg Q6M，3）600 mg Q3M或安慰剂。

The dose arms support the potential to provide patient-centric dosing flexibility to people with HAE. The primary endpoint is time-normalized monthly HAE attacks at 6 months, and a key secondary endpoint includes the proportion of participants who are attack-free at 6 months. After 6 months, patients may be eligible to enter a long-term extension trial, in which all patients will be treated with navenibart (open-label) and which will include an open-label, patient-centric flexible dosing period.

剂量臂支持为HAE患者提供以患者为中心的剂量灵活性的潜力。。6个月后，患者可能有资格进入长期延长试验，在该试验中，所有患者将接受纳维尼巴特（开放标签）治疗，其中将包括开放标签，以患者为中心的灵活给药期。

The navenibart Phase 3 program will consist of the ALPHA-ORBIT Phase 3 trial and the long-term extension trial, which are designed to support registration globally. The Phase 3 program was designed with input from the European Medicines Agency and the Company’s end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) held in December 2024..

navenibart三期项目将包括ALPHA-ORBIT三期试验和长期延期试验，旨在支持全球注册。第三阶段计划是根据欧洲药品管理局的意见设计的，该公司于2024年12月与美国食品和药物管理局（FDA）举行了第二阶段会议。。

Planned doses for the Phase 3 ALPHA-ORBIT program were selected based on positive final top-line results from target enrollment in the Phase 1b/2 ALPHA-STAR trial of navenibart, announced in December 2024, which showed rapid onset of robust and durable efficacy, favorable safety and tolerability, and pharmacokinetics and pharmacodynamics consistent with sustained plasma kallikrein inhibition for both Q3M and Q6M administration.

第三阶段ALPHA-ORBIT计划的计划剂量是根据2024年12月宣布的navenibart 1b/2期ALPHA-STAR试验目标登记的最终结果选择的，该试验显示，Q3M和Q6M给药均能快速起效，具有良好的安全性和耐受性，以及与持续血浆激肽释放酶抑制相一致的药代动力学和药效学。

Final results included reduction in mean monthly attack rate of 90-95% and up to a 67% attack-free rate over 6 months. The Company will present these data at an upcoming scientific conference..

最终结果包括平均每月发作率降低90-95%，6个月内无发作率高达67%。该公司将在即将举行的科学会议上展示这些数据。。

Additional details regarding the Company’s planned Phase 3 program and other business updates are contained in the Company’s Corporate Presentation, which is available on the “Events and Presentations” page of the “For Investors” section of the Company’s website.

有关公司计划的第三阶段计划和其他业务更新的其他详细信息，请参阅公司网站“投资者”部分的“活动和演示”页面上的公司演示文稿。

About Astria Therapeutics

关于Astria Therapeutics

:

:

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema.

Astria Therapeutics是一家生物制药公司，我们的使命是为受过敏性和免疫性疾病影响的患者和家庭带来改变生活的疗法。我们的主要项目navenibart（STAR-0215）是临床开发中用于治疗遗传性血管性水肿的血浆激肽释放酶单克隆抗体抑制剂。

Our second program, STAR-0310, is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis. Learn more about our company on our website, .

我们的第二个程序STAR-0310是一种单克隆抗体OX40拮抗剂，用于治疗特应性皮炎的临床前开发。在我们的网站上了解更多关于我们公司的信息。

www.astriatx.com

www.astriatx.com

, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn.

，或者在Instagram@AstriaTx以及Facebook和LinkedIn上关注我们。

About Navenibart:

关于Navenibart：

Navenibart is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered every 3 and 6 months. We aim to empower people with HAE to live life without limitations from their disease..

Navenibart是血浆激肽释放酶的单克隆抗体抑制剂，正在开发用于治疗HAE。我们与navenibart的目标是通过每3个月和6个月进行一次有效的机制和可信的方式，提供快速和持续的HAE发作预防。我们的目标是使HAE患者能够不受疾病的限制地生活。。

Forward Looking Statements:

前瞻性声明：

This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the expected design, timing of initiation and receipt of topline results from the ALPHA-ORBIT trial; the goals and objectives of the ALPHA-ORBIT trial and the long-term extension trial, including that they would support registration of Q3M and Q6M administration, and potentially accelerate the availability of Q6M administration; our expectations for the dosing regimens of navenibart and the efficacy data of navenibart in the ALPHA-ORBIT trial; the potential therapeutic benefits of navenibart as a treatment for HAE; the potential attributes and profile of navenibart as a treatment for HAE, including our expectation that it will be the market-leading, first choice and a potentially life-changing treatment for patients with HAE; our overall vision and goals for the navenibart program; expectations about being funded through top-line Phase 3 results; and our corporate strategy and vision, including our mission to bring life-changing therapies to patients and families affected by allergic and immunologic diseases.

本新闻稿包含适用证券法律法规含义内的前瞻性声明，包括但不限于以下声明：ALPHA-ORBIT试验的预期设计、启动时间和接收topline结果；ALPHA-ORBIT试验和长期延期试验的目标和目的，包括它们将支持Q3M和Q6M管理的注册，并可能加速Q6M管理的可用性；我们对navenibart给药方案的期望以及ALPHA-ORBIT试验中navenibart的疗效数据；navenibart作为HAE治疗的潜在治疗益处；navenibart作为HAE治疗的潜在属性和概况，包括我们的期望，即它将成为HAE患者的市场领先，首选和潜在的改变生命的治疗方法；我们对navenibart项目的总体愿景和目标；对通过第三阶段顶线成果获得资金的期望；。

The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or 'vision,' and similar words and expressions are intended to identify forward-looking statements.

使用诸如但不限于“预期”、“相信”、“继续”、“可能”、“估计”、“预期”、“目标”、“打算”、“可能”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“将会”、“将会”或“愿景”等词语，以及类似的词语和表达旨在识别前瞻性陈述。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, .

前瞻性陈述既不是历史事实，也不是未来表现的保证。相反，它们是基于阿斯特里亚目前对其业务未来、未来计划和战略、未来财务业绩的信念、期望和假设。

Neither Astria, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Astria’s views as of any date subsequent to the date hereof..

Astria及其关联公司、顾问或代表均无义务公开更新或修订任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律要求。这些前瞻性声明不应被视为代表阿斯特里亚在本协议日期之后的任何日期的观点。。