BOSTON, Mass.--(BUSINESS WIRE)--Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced positive initial proof-of-concept results from the ALPHA-STAR Phase 1b/2 clinical trial evaluating STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients.

波士顿，马萨诸塞州。-（商业新闻短讯）--Astria Therapeutics，Inc.（纳斯达克：ATXS），一家专注于开发针对过敏性和免疫性疾病的改变生命的疗法的生物制药公司，今天宣布了对遗传性血管性水肿（HAE）患者进行血浆激肽释放酶单克隆抗体抑制剂STAR-0215评估的ALPHA-STAR 1b/2期临床试验的初步概念验证结果。

Initial results demonstrate a favorable safety and tolerability profile, mean monthly attack rate reduction of 90-96% for up to 6 months of follow up, and support both three- (Q3M) and six-month (Q6M) dosing regimens. Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026..

初步结果表明，良好的安全性和耐受性，随访6个月，平均每月发作率降低90-96%，并支持三（Q3M）和六个月（Q6M）给药方案。基于积极的结果，阿斯特里亚计划将STAR-0215推进到第三阶段的开发，预计2025年第一季度开始试用，2026年底取得最佳结果。。

“We are thrilled with these initial results from ALPHA-STAR and believe that STAR-0215 can be a transformative therapy for patients that greatly reduces their disease and treatment burdens,” said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “These results give us conviction that we will be able to deliver STAR-0215 once every three and six months, and we look forward to progressing this program into Phase 3 as quickly as possible.”.

Astria Therapeutics首席医疗官克里斯托弗·莫拉比托（ChristopherMorabito）医学博士说：“我们对ALPHA-STAR的这些初步结果感到兴奋，并相信STAR-0215可以成为患者的一种变革性疗法，大大减轻患者的疾病和治疗负担。”。“这些结果使我们相信，我们将能够每三个月和六个月交付一次STAR-0215，我们期待着尽快将该计划推进到第三阶段。”。

“The initial results of the ALPHA-STAR trial represent a very exciting step forward in the HAE treatment landscape,” said Marcus Maurer, M.D., Executive Director of the Institute of Allergology at Charite – Universitatsmedizin Berlin. “STAR-0215 has the potential to help patients manage their disease with a mechanism and modality that they trust, but with a substantially improved dosing regimen and the ability to administer without pain.

柏林Charite-Universitatsmedizin过敏研究所执行主任马库斯·莫雷尔（MarcusMaurer）医学博士说：“ALPHA-STAR试验的初步结果代表了HAE治疗领域向前迈出了非常令人兴奋的一步。”。“STAR-0215有可能帮助患者以他们信任的机制和方式管理他们的疾病，但其给药方案得到了显着改善，并且能够无痛给药。

Based on this profile, STAR-0215 has the potential to normalize the lives of people living with HAE.”.

根据这一概况，STAR-0215有可能使HAE患者的生活正常化。”。

'Thanks to the enthusiasm for STAR-0215, the ALPHA-STAR trial enrolled ahead of schedule, enabling us to report these data earlier than originally scheduled,” said Jill C. Milne, Ph.D., Chief Executive Officer. “We believe STAR-0215 has the potential to be the first-choice HAE treatment and I am thankful for the HAE community and the Astria team for helping us to achieve today’s important milestone.”.

首席执行官吉尔·米尔恩（JillC.Milne）博士说：“由于人们对STAR-0215的热情，ALPHA-STAR试验提前报名，使我们能够比原定计划更早地报告这些数据。”。“我们相信STAR-0215有可能成为HAE治疗的首选药物，我感谢HAE社区和Astria团队帮助我们实现今天的重要里程碑。”。

ALPHA-STAR is a dose-ranging proof-of-concept trial in adults with HAE Type 1 or 2 designed to assess safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and quality of life in patients receiving single and multiple doses of STAR-0215 delivered subcutaneously to prevent attacks in HAE.

ALPHA-STAR是一项针对成人HAE 1型或2型的剂量范围概念验证试验，旨在评估接受单剂量和多剂量STAR-0215皮下注射以预防HAE发作的患者的安全性，耐受性，有效性，药代动力学（PK），药效学（PD）和生活质量。

Target enrollment of 16 patients has been achieved and all doses have been administered. All cohorts began with an eight-week run-in period to measure baseline HAE attacks and safety, efficacy, PK, and PD are assessed through 6-months (Day 168) after the last dose received. The initial efficacy and safety data-cut was as of March 13, 2024..

已经实现了16名患者的目标入组，并且已经施用了所有剂量。所有队列均以八周的磨合期开始，以测量基线HAE发作，并在接受最后一剂后的6个月（第168天）评估安全性，有效性，PK和PD。最初的疗效和安全性数据截止到2024年3月13日。。

Cohort 1 evaluated a 450 mg dose and all four patients have completed 6 months of follow-up. Efficacy observations compared to baseline through 6 months of follow-up were as follows:

队列1评估了450 mg剂量，所有四名患者均完成了6个月的随访。通过6个月的随访，与基线相比，疗效观察结果如下：

92% reduction in monthly attack rate

每月攻击率降低92%

96% reduction in moderate and severe attacks

中度和重度发作减少96%

91% reduction in acute rescue medication use

急性救援药物使用减少91%

50% of patients were attack-free through 3 months of follow-up

经过3个月的随访，50%的患者无发作

Cohort 2 evaluated a 600 mg dose followed by a 300 mg dose three months later, on Day 84. The Company plans to evaluate this dosing regimen in Phase 3. All six patients have completed 3 months of follow up and three patients have completed 6 months of follow-up. Efficacy observations compared to baseline through 6 months of follow-up were as follows:.

队列2在第84天评估了600毫克剂量，然后在三个月后评估了300毫克剂量。该公司计划在第三阶段评估这种给药方案。所有六名患者均完成了3个月的随访，三名患者完成了6个月的随访。通过6个月的随访，与基线相比，疗效观察结果如下：。

96% reduction in monthly attack rate

每月攻击率降低96%

98% reduction in moderate and severe attacks

中度和重度发作减少98%

94% reduction in acute rescue medication use

急性救援药物使用减少94%

67% of patients were attack-free

67%的患者无发作

100% of patients were attack-free in the first month after dosing, demonstrating rapid onset of action

100%的患者在给药后的第一个月内没有发作，表明起效迅速

Cohort 3 received a 600 mg dose followed by a 600 mg dose one month later, on Day 28. Four of six patients have completed 3 months of follow-up. Efficacy observations compared to baseline through 3 months of follow-up were as follows:

队列3在第28天接受600毫克剂量，然后在一个月后接受600毫克剂量。六名患者中有四名已完成3个月的随访。通过3个月的随访，与基线相比，疗效观察结果如下：

90% reduction in monthly attack rate

每月攻击率降低90%

100% reduction in moderate and severe attacks

中度和重度发作减少100%

95% reduction in acute rescue medication use

急性救援药物使用减少95%

50% of patients were attack-free

50%的患者无发作

Preliminary PK and PD data are consistent with Phase 1a data in healthy subjects and consistent with observed efficacy.

初步PK和PD数据与健康受试者的1a期数据一致，并与观察到的疗效一致。

STAR-0215 was generally well-tolerated with no serious treatment-emergent adverse events (TEAEs) and no discontinuations. There were two treatment-related TEAEs (both mild), one of which was a case of dizziness and the other a transient injection site reaction (rash). There were no injection site reactions of pain..

STAR-0215通常耐受性良好，没有严重的治疗紧急不良事件（TEAE），也没有停药。有两种与治疗相关的TEAE（均为轻度），其中一种是头晕，另一种是短暂的注射部位反应（皮疹）。没有注射部位的疼痛反应。。

After completion of the ALPHA-STAR trial, patients have the opportunity to continue to receive STAR-0215 every three or six months in the long-term open label ALPHA-SOLAR trial. Initial safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR trial are expected mid-2025.

在完成ALPHA-STAR试验后，患者有机会在长期开放标签ALPHA-SOLAR试验中每三个月或六个月继续接受STAR-0215。预计2025年年中，ALPHA-SOLAR试验中Q3M和Q6M剂量的初始安全性和有效性数据。

The observed efficacy, PK, PD, and safety and tolerability profile of STAR-0215 support advancement of STAR-0215 into Phase 3 development. To progress STAR-0215 to market as quickly as possible, the Company plans to focus the Phase 3 program on Q3M dosing initially, immediately followed by a second trial to support label expansion to Q6M.

STAR-0215的观察到的功效，PK，PD以及安全性和耐受性概况支持STAR-0215进入第3阶段开发。为了尽快将STAR-0215推向市场，该公司计划首先将第三阶段计划的重点放在Q3M剂量上，然后立即进行第二次试验，以支持标签扩展到Q6M。

Pending regulatory feedback, the Company expects to start a pivotal Q3M Phase 3 trial in Q1 2025, with top-line results expected by year-end 2026..

在等待监管部门的反馈之前，该公司预计将于2025年第一季度开始关键的第三季度第三阶段试验，预计2026年底取得最佳结果。。

The Company expects that its current cash, cash equivalents, and short-term investments of $246.5 million as of December 31, 2023, plus $137.1 million from financing activity in the first quarter of 2024, will be sufficient to fund the Company into mid-2027 including all STAR-0215 program activities through the completion of a planned Q3M Phase 3 pivotal trial as well as advancing the Company’s STAR-0310 OX40 program through IND submission and early proof-of-concept results from a Phase 1a trial..

该公司预计，截至2023年12月31日，其目前的现金、现金等价物和短期投资为2.465亿美元，再加上2024年第一季度融资活动产生的1.371亿美元，将足以资助该公司到2027年年中，包括通过完成计划的第三季度关键性试验以及通过IND提交和1a期试验的早期概念验证结果推进公司的STAR-0310 OX40计划，从而完成所有STAR-0215计划活动。。

Webcast Information

网络广播信息

The Company will host a webcast today at 8:30am ET. Interested parties may join the webcast via the Investors section of the Astria website, www.astriatx.com or with following the link https://lifescievents.com/event/astriatx/. The webcast will be archived for 90 days.

该公司将于美国东部时间今天上午8:30主持网络广播。感兴趣的各方可以通过Astria网站的投资者部分（www.astriatx.com）或以下链接加入网络广播https://lifescievents.com/event/astriatx/.网络广播将存档90天。

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 immunological diseases. Our lead program, 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, www.astriatx.com, or follow us on X and Instagram @AstriaTx and on Facebook and LinkedIn..

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www.astriatx.com上了解更多关于我们公司的信息，或者在X和Instagram@astriatx以及Facebook和LinkedIn上关注我们。。

About STAR-0215:

关于STAR-0215：

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Our goal with STAR-0215 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 living with HAE to live life without limitations from their disease.

STAR-0215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。我们使用STAR-0215的目标是通过每3个月和6个月一次的有效机制和可信方式，提供快速持续的HAE发作预防。我们的目标是使患有HAE的人能够不受疾病的限制地生活。

Pending regulatory feedback, we expect to initiate a pivotal Q3M Phase 3 trial in Q1 of 2025 with top-line results expected by year-end 2026..

等待监管部门的反馈，我们预计将在2025年第一季度启动关键的Q3M第三阶段试验，预计到2026年底取得最佳结果。。

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: our expectations regarding the potential significance of the initial results from the Phase 1b/2 ALPHA-STAR clinical trial of STAR-0215, and that the results from such trial will allow us to move directly into a Phase 3 trial of STAR-0215 as a potential treatment for hereditary angioedema (HAE); the expected timing of initiation and design of the planned Phase 3 trials of STAR-0215; the potential therapeutic benefits of STAR-0215 as a treatment for HAE; the potential market impact of STAR-0215 as a treatment for HAE and our vision and goals for the STAR-0215 program; expectations regarding the timing of initiation and planned design of clinical trials for STAR-0310 in AD; expectations regarding the timing and nature of anticipated data from planned trials of STAR-0310; our anticipated cash runway; and our corporate strategy and vision, including the goal to meet the unmet needs of patients with rare and niche allergic and immunological 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：我们对STAR-0215 1b/2期ALPHA-STAR临床试验初步结果的潜在意义的期望，以及此类试验的结果将使我们能够直接进入STAR-0215的3期试验，作为遗传性血管性水肿（HAE）的潜在治疗方法；STAR-0215计划的3期试验的启动和设计的预期时间；STAR-0215作为HAE治疗的潜在治疗益处；STAR-0215作为HAE治疗的潜在市场影响以及我们对STAR-0215计划的愿景和目标；关于AD中STAR-0310临床试验的启动时间和计划设计的期望；对STAR-0310计划试验的预期数据的时间和性质的期望；我们预期的现金跑道；以及我们的公司战略和愿景，包括满足罕见和利基过敏性和免疫性疾病患者未满足需求的目标。

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 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, results of pre-clinical and clinical results of the Astria’s product .

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Astria目前对其业务未来、未来计划和战略、未来财务业绩、Astria产品的临床前和临床结果的信念、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。。