Armata Pharmaceuticals宣布了在复杂金黄色葡萄球菌菌血症中静脉注射 AP-SA02的 1b/2a期 diSArm研究的积极顶线数据-动脉网

Armata Pharmaceuticals Announces Positive Topline Data from the Phase 1b/2a diSArm Study of Intravenously Administered AP-SA02 in Complicated Staphylococcus aureus Bacteremia

CISION 等信源发布 2025-05-19 19:00

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可切换为仅中文

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All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met

意向治疗人群中的所有安全性、耐受性和临床反应的主要终点均达到。

AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic

AP-SA02 菌株显著改善了临床结果，并防止了复发，相较于最佳可用抗生素。

therapy

治疗

No treatment-related serious adverse events were observed with repetitive intravenous dosing

重复静脉给药未观察到与治疗相关的严重不良事件。

LOS ANGELES

洛杉矶

，

May 19, 2025

2025年5月19日

/PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ('Armata' or the 'Company'), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced positive topline results from its Phase .

/PRNewswire/ -- Armata Pharmaceuticals, Inc.（NYSE American: ARMP）（“Armata”或“公司”），一家专注于开发高纯度、针对特定病原体的噬菌体疗法的临床阶段生物技术公司，旨在治疗抗生素耐药和难以治愈的细菌感染，今天宣布了其第二阶段试验的积极顶线结果。

/2a diSArm trial which evaluated AP-SA02, a novel intravenous ('IV') administered multi-phage therapeutic for the treatment of

/2a diSArm 试验评估了 AP-SA02，一种新型的静脉注射（“IV”）多噬菌体治疗药物，用于治疗

taphylococcus

葡萄球菌

aureus

金黄色的

S. aureus

金黄色葡萄球菌

') bacteremia ('SAB'), in the intent-to-treat ('ITT') population.

`) 菌血症 ('SAB')，在意向治疗 ('ITT') 人群中。`

'This trial and these data are what the field of phage therapy has been eagerly awaiting for over a decade and represent a critical leap forward for Armata and for the role of bacteriophages in combating life-threatening systemic infections,' stated Dr.

“这项试验和这些数据是噬菌体治疗领域十多年来一直迫切期待的，标志着Armata公司和噬菌体在对抗危及生命的全身感染中的作用迈出了关键的一步，”博士说道。

Deborah Birx

黛博拉·伯克斯

, Chief Executive Officer of Armata.

Armata首席执行官。

The diSArm study (

diSArm 研究 (

NCT05184764

) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy ('BAT') compared to BAT alone (placebo) for the treatment of adults with complicated SAB..

）是一项Phase 1b/2a期、多中心、随机、双盲、安慰剂对照、多剂量递增研究，评估静脉注射AP-SA02联合最佳可用抗生素治疗（“BAT”）对比单独使用BAT（安慰剂）治疗成人复杂SAB的安全性、耐受性和有效性。

Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.

在意向治疗（ITT）人群中评估了安全性和有效性，该人群包括所有接受至少一剂AP-SA02或安慰剂的受试者（n=50）。

AP-SA02, administered IV every six hours for five days, was well-tolerated, with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly related to the study drug: one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin..

每六小时静脉注射一次AP-SA02，持续五天，耐受性良好，未发现与研究药物相关的严重不良事件。两名受试者发生了可能与研究药物相关的不良事件：一名出现短暂的肝酶升高，另一名出现超敏反应，在停用万古霉素后得以缓解。

The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure ('TOC') for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study ('EOS'), defined as four weeks following the end of IV BAT..

diSArm 研究的 2a 期部分的主要临床疗效终点是复杂菌血症受试者的临床结果（应答率），在以下时间点测量：(i) AP-SA02 的治愈检验（TOC），定义为 AP-SA02 静脉注射治疗结束（第12天）后一周；(ii) BAT 的治愈检验（TOC），定义为静脉注射 BAT 治疗结束后一周；以及 (iii) 研究结束（EOS），定义为静脉注射 BAT 治疗结束后四周。

A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%) versus placebo (58%) (p = 0.047). At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials.

在AP-SA02治疗的受试者（88%）与安慰剂组（58%）中，研究者评估的TOC（第12天）反应率有统计学显著性增加（p = 0.047）。在BAT的TOC和EOS时，100%的AP-SA02治疗受试者表现出临床反应（p = 0.017），而安慰剂组中有25%的受试者因复发或治疗失败被认为无反应，这与近期第三阶段试验文献中报告的无反应率一致。

Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive .

值得注意的是，无论受试者是否感染了甲氧西林敏感菌，AP-SA02都会产生临床反应。

S. aureus

金黄色葡萄球菌

('MSSA') or methicillin-resistant

('MSSA') 或甲氧西林耐药

S. aureus

金黄色葡萄球菌

('MRSA'). All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.

('MRSA')。所有感染MRSA并使用AP-SA02和BAT治疗的受试者在BAT的TOC时清除了感染，且在EOS期间无复发迹象，相比之下，单独使用BAT的复发率如上所述。

Supporting the investigator assessment, clinical outcome was assessed by the Clinical Efficacy Adjudication Committee, comprised of leading doctors in the bacteremia field, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025: TOC BAT; p = 0.020: EOS).

支持研究者评估的临床结果由临床疗效裁定委员会进行评估，该委员会由菌血症领域的领先医生组成，他们一致认为，接受安慰剂的受试者在治愈检验（TOC）时使用BAT和在研究结束（EOS）时的无应答率分别为22%和25%，而接受AP-SA02的所有受试者均表现出临床应答（p = 0.025：TOC BAT；p = 0.020：EOS）。

Additionally, faster time to a negative blood culture and decline of key predictors of mortality and complications in SAB, including interleukin-10 and C-reactive protein, support the improved responder rates in subjects treated with AP-SA02..

此外，更快的血培养转阴时间和金黄色葡萄球菌菌血症（SAB）中关键的死亡率及并发症预测指标（包括白细胞介素-10和C反应蛋白）的下降，支持了使用AP-SA02治疗的受试者中较高的应答率改善。

'This clinical trial is groundbreaking in two fundamental ways: firstly, this is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in

“这项临床试验在两个基本方面具有开创性：首先，这是在随机对照试验中首次明确证明噬菌体对一种导致严重发病率和死亡率的重要系统性病原体的有效性的证据。

the United States

美国

, and secondly, Armata was able to successfully produce high titer phage with high purity allowing for repetitive IV administration every six hours without significant safety concerns,' continued Dr. Birx.

“其次，Armata能够成功生产出高滴度、高纯度的噬菌体，允许每六小时重复静脉注射，而没有显著的安全隐患，”比克斯博士继续说道。

'We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push. Critically, these trial results support AP-SA02 homing to different sites of infection, presumably penetrating biofilms, and infecting and lysing the target

“我们之前已经证明了AP-SA02在静脉注射后一小时于静脉空间中多天的持久性。重要的是，这些试验结果支持AP-SA02归巢到不同的感染部位，推测其能够穿透生物膜，并感染和裂解目标。

S. aureus

金黄色葡萄球菌

bacteria, independent of antibiotic resistance patterns and site of infection.'

细菌，独立于抗生素耐药模式和感染部位。

'These data, including the favorable safety profile of AP-SA02, warrant that we move as rapidly as possible towards initiation of a pivotal trial. I am grateful to the patients who participated in this study, our excellent trial sites, and the unrelenting commitment of the Armata team. Finally, this progress and this initial breakthrough would not have been possible without ongoing support from Innoviva and the U.S.

“这些数据，包括AP-SA02的良好安全性，促使我们需要尽快启动一项关键试验。我非常感谢参与这项研究的患者、我们优秀的试验基地以及Armata团队不懈的投入。最后，如果没有Innoviva和美国的持续支持，这一进展和初步突破是不可能实现的。

Department of Defense.'.

国防部。

'Importantly, Armata has developed the capacity to manufacture drug product at its cGMP facility in

“重要的是，Armata已经发展出在其cGMP设施中生产药物产品的能力

California

加利福尼亚州

. All Active Pharmaceutical Ingredients are maintained in house and Armata's current proprietary manufacturing process can produce over 10,000 full courses of phage therapy annually, distributed from its facility, consistent with supporting the need to onshore biomedical breakthroughs needed by the American people,' Dr.

所有活性药物成分均在公司内部保存，阿玛塔当前专有的生产工艺每年可生产超过一万份完整的噬菌体疗程，并从其设施分发，符合支持美国人民所需的生物医学突破的要求。

Birx concluded..

伯克斯总结道。

Armata's latest corporate presentation with topline results from the Phase

Armatas 最新的企业报告展示了其第三阶段的顶级成果

/2a diSArm study can be found

/2a diSArm 研究可以找到

here

这里

。

About Armata Pharmaceuticals, Inc.

关于Armata Pharmaceuticals公司。

Armata is a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for .

Armata是一家处于临床阶段的生物技术公司，专注于利用其专有的噬菌体技术开发高纯度病原体特异性噬菌体疗法，用于治疗抗生素耐药性和难以治疗的细菌感染。Armata正在开发和推进一系列天然和合成噬菌体候选药物，其中包括临床候选药物。

Pseudomonas aeruginosa, Staphylococcus aureus

铜绿假单胞菌，金黄色葡萄球菌

, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific current Good Manufacturing Practices ('cGMP') manufacturing to support full commercialization.

，以及其他病原体。Armata 致力于推进噬菌体疗法，其药物开发专业知识涵盖从实验室到临床的全过程，包括内部噬菌体特定的现行良好生产规范（'cGMP'）生产，以支持全面商业化。

Forward Looking Statements

前瞻性声明

This communication contains 'forward-looking' statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements.

本通讯包含根据1995年《私人证券诉讼改革法案》定义的“前瞻性”陈述。这些陈述涉及未来事件、结果或Armata未来的财务表现，并涉及已知和未知的风险、不确定性以及其他可能导致Armata的实际结果、表现或事件与前瞻性陈述中表达或暗示的未来结果、表现或事件存在重大差异的因素。

In some cases, you can identify these statements by terms such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant cGMP; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds.

在某些情况下，您可以通过诸如“预期”、“相信”、“可能”、“估计”、“预计”、“打算”、“或许”、“计划”、“潜力”、“预测”、“预计”、“应该”、“将”、“会”或这些词语的否定形式以及类似表述来识别这些声明。这些前瞻性声明反映了管理层对未来事件的看法和观点，并基于本通讯日期时的估计和假设，同时受制于风险和不确定性，包括与Armata开发基于噬菌体疗法相关的风险；具备完全合规的cGMP生产能力并维持其生产设施的能力；实现相关产品开发和测试预期里程碑的能力；在噬菌体疗法开发领域保持领先地位的能力；实现其愿景的能力，包括通过工程改进及临床试验的成功；成功完成临床前和临床开发、获得其候选产品的监管批准并按预期时间表或根本将其商业化的能力；以及Armata对预期运营亏损、资本需求和额外资金需求的估计。

Additional risks and uncertainties relating to Armata and its busi.

与Armata及其业务相关的其他风险和不确定性。

March 21, 2025

2025年3月21日

, and in its subsequent filings with the SEC.

，并在其随后向美国证券交易委员会（SEC）提交的文件中。

Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. .

Armata 明确声明，不承担任何义务或承诺公开发布对本文中包含的任何前瞻性陈述的更新或修订，以反映 Armata 对此的期望的任何变化或任何此类陈述所基于的事件、条件或情况的任何变化。

Media Contacts:

媒体联系人：

At Armata:

在阿玛塔：

Pierre Kyme

皮埃尔·凯姆

ir@armatapharma.com

310-665-2928

Investor Relations:

投资者关系：

Joyce Allaire