A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections.
The study will include newborns and infants up to 9 months of age who are admitted in the hospital.
The study is conducted in 2 parts: Part A and Part B.
In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount.
In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

开始日期2024-09-25

申办/合作机构

Pfizer Inc.

[+1]

CTR20233317

/ Recruiting临床2期

一项在患有严重革兰阴性菌感染（包括复杂性腹腔内感染）的9 月龄至18 岁以下儿童受试者中研究氨曲南-阿维巴坦静脉给药联用或不联用甲硝唑与最佳可用治疗（BAT）相比的药代动力学、安全性、耐受性和有效性的IIa 期、多中心、观察者设盲、随机双臂研究

该研究拟使用的生物样本来自于确诊为严重革兰阴性菌感染的受试者。本研究的研究目的为在 9 月龄至<18 岁受试者中评估 ATM－AVI用于治疗严重革兰阴性菌感染的 PK 和在 9 月至<18岁受试者中评估 ATM－AVI 和BAT用于治疗严重革兰阴性菌感染的安全性和耐受性及疗效，拟使用全血、血清等人类遗传资源进行分析和检测。

开始日期2024-07-24

申办/合作机构

Pfizer Inc.

[+2]

NCT05639647

/ Recruiting临床2期

A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION

The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
The study is seeking participants who are:
* 9 months to less than 18 years of age
* Hospitalized
* Suspected/known to have a gram-negative infection
* Receiving intravenous (iv, given directly into a vein) antibiotics
* Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs.
* Participants will receive either ATM-AVI or best available therapy (BAT).
* Both therapies will be given through a vein.
* Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion.
* The iv dose of ATM-AVI will be based on the participant's weight and kidney function.
* The study doctor will determine the iv dose of BAT.
* During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities.
* Starting on day 4, the study doctor will decide if participants may be switched to oral therapy.
* Participants will receive a maximum of 14 days of ATM-AVI treatment.
* After discharge from the hospital, 1 study visit may be required.
* Depending on the participant's response, the study duration will be from 33 to 50 days.
* The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.

开始日期2023-04-18

申办/合作机构

Pfizer Inc.

100 项与阿维巴坦钠/氨曲南相关的临床结果

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100 项与阿维巴坦钠/氨曲南相关的专利（医药）

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项与阿维巴坦钠/氨曲南相关的文献（医药）

2025-02-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Multiple mechanisms mediate aztreonam-avibactam resistance in Klebsiella pneumoniae: Driven by KPC-2 and OmpK36 mutations

Article

作者: Xiang, Xinli ; Zhou, Tieli ; Kong, Jingchun ; Zhang, Jia ; Sun, Yao ; Qian, Changrui ; Zhang, Xiaotuan

Aztreonam-avibactam (ATM-AVI) is a promising β-lactam/β-lactamase inhibitor combination with an antimicrobial spectrum covering serine carbapenemase- or metallo-β-lactamase-producing Enterobacterales. Although ATM-AVI has not been widely used in clinical practice, resistance to it in Escherichia coli has been widely reported. In this study, we investigated an ATM-AVI-resistant Klebsiella pneumoniae strain, designated as 1705R, derived from K. pneumoniae ATCC BAA-1705 by induction, with a minimal inhibitory concentration of 128 µg/mL. The 1705R strain contained two copies of the bla_KPC-2 variant, which encodes for a K. pneumoniae carbapenemase (KPC) variant with a Ser109Pro substitution, as well as a premature termination in OmpK36 and OmpK35 porins. This KPC variant decreased susceptibility to ATM-AVI by four-fold and demonstrated a reduced affinity for ATM and AVI in molecular docking analysis. In porin-deficient strains harbouring this KPC variant, ATM-AVI susceptibility was further diminished, exhibiting a 32-fold reduction. Whole-genome sequencing revealed that the transposition of Tn4401 carrying bla_KPC from the IncFIB/FIIK plasmid into the ColRNAI plasmid produced a second copy of bla_KPC. Quantitative polymerase chain reaction revealed that the copy number of bla_KPC and its carrier plasmid increased, which significantly up-regulated their mRNA expression. Overexpression of the AcrAB-TolC efflux pump may also be associated with high levels of ATM-AVI resistance. Furthermore, collateral susceptibility and costs of growth and biofilm formation developed after the acquisition of ATM-AVI resistance. This study demonstrates that multiple molecular mechanisms collectively contribute to ATM-AVI resistance in K. pneumoniae 1705R strain, which may represent a mode of resistance to ATM-AVI.

2025-02-01·LANCET INFECTIOUS DISEASES

Aztreonam–avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial

Article

作者: Chen, Gang ; Wible, Michele ; Daikos, George L ; Luckey, Alison ; Leaney, Joanne L ; Liang, Lu ; Chow, Joseph W ; Paul, Mical ; Aksoy, Firdevs ; Torre-Cisneros, Julian ; Carmeli, Yehuda ; Gumenchuk, Illia ; Titov, Ivan ; Goossens, Herman ; Jiménez-Rodríguez, Rosa-María ; Wang, Minggui ; Pyptiuk, Oleksandr ; Cisneros, José Miguel ; Lammens, Christine ; Zhao, Yongjie ; Arhin, Francis F ; Rogers, Halley ; Pypstra, Rienk ; Malhotra-Kumar, Surbhi ; Singer, George ; Rodríguez-Baño, Jesús ; Bonten, Marc

BACKGROUND:

There is a need for additional therapeutic options for serious infections caused by Gram-negative pathogens. In the phase 3, descriptive REVISIT study, we investigated the safety and efficacy of aztreonam-avibactam in the treatment of complicated intra-abdominal infections or hospital-acquired pneumonia or ventilator-associated pneumonia (HAP-VAP) caused, or suspected to be caused, by Gram-negative bacteria.

METHODS:

This prospective, multinational, open-label, central assessor-masked study enrolled adults who were hospitalised with a complicated intra-abdominal infection or HAP-VAP. Patients were randomly allocated via block randomisation using interactive response technology stratified by infection type in a 2:1 ratio to aztreonam-avibactam (with metronidazole for complicated intra-abdominal infection) or meropenem with or without colistin for 5-14 days for complicated intra-abdominal infection or 7-14 days for HAP-VAP. The primary endpoint was clinical cure at the test-of-cure visit (within 3 days before or after day 28) in the intention-to-treat (ITT) population. Secondary endpoints included 28-day mortality in the ITT population and safety in patients in the ITT population who received study drug (safety analysis set). No formal hypothesis testing was planned. The study was registered with ClinicalTrials.gov (NCT03329092) and EudraCT (2017-002742-68) and is complete.

FINDINGS:

Between April 5, 2018, and Feb 23, 2023, we screened 461 patients. 422 patients were enrolled and randomly allocated (282 in the aztreonam-avibactam group and 140 in the meropenem group, forming the ITT analysis set), of whom ten patients (seven in the aztreonam-avibactam group and three in the meropenem group) were randomly allocated but did not receive study treatment. 271 (64%) of 422 patients had at least one Gram-negative pathogen from an adequate specimen identified at baseline. The most frequent baseline pathogens were Enterobacterales (252 [93%] of 271). Overall, 19 (24%) of 80 isolates tested for carbapenemases were carbapenemase-positive (serine, metallo-β-lactamase, or both). 193 (68·4%) of 282 patients in the aztreonam-avibactam group and 92 (65·7%) of 140 in the meropenem group had clinical cure at the test-of-cure visit (treatment difference 2·7% [95% CI -6·6 to 12·4]). For patients with complicated intra-abdominal infection, the adjudicated clinical cure rate was 76·4% (159 of 208) for the aztreonam-avibactam group and 74·0% (77 of 104) for the meropenem group. Cure rates in patients with HAP-VAP were 45·9% (34 of 74) for aztreonam-avibactam and 41·7% (15 of 36) for meropenem. 28-day all-cause mortality rates were 4% (12 of 282) for aztreonam-avibactam and 7% (ten of 140) for meropenem; in patients with complicated intra-abdominal infection, mortality was 2% (four of 208) and 3% (three of 104) for aztreonam-avibactam and meropenem, respectively, and in patients with HAP-VAP, mortality was 11% (eight of 74) and 19% (seven of 36), respectively. Aztreonam-avibactam was generally well tolerated, and safety findings were consistent with the known safety profile of aztreonam monotherapy. There were no treatment-related serious adverse events in the aztreonam-avibactam group.

INTERPRETATION:

These phase 3 efficacy and safety data provide support for aztreonam-avibactam as a potential therapeutic option for complicated intra-abdominal infection or HAP-VAP caused by Gram-negative bacteria.

FUNDING:

Pfizer.

2025-01-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Antimicrobial Susceptibility of Clinical Isolates of Stenotrophomonas maltophilia Isolates from Europe, Asia, and Latin America (2018–2023)

Article

作者: Sader, Helio S ; Doyle, Timothy B ; Winkler, Marisa L ; Mendes, Rodrigo E ; Castanheira, Mariana

BACKGROUND:

The occurrence of Stenotrophomonas maltophilia infections, especially pneumonia, has increased consistently in the last years. We evaluated the antimicrobial susceptibility of a large collection of S. maltophilia collected in Europe, Asia, and Latin America.

METHODS:

1,287 clinical isolates were collected from 71 medical centres located in Western Europe (W-EU; n=682; 28 centers in 10 countries), Eastern Europe (E-EU; n=320; 18 centers in 11 countries), the Asia-Pacific region (APAC; n=182; 15 centers in 7 countries), and Latin America (LATAM; n=103; 10 centers in 7 countries). Most isolates were from patients with pneumonia (n=790) and bloodstream infection (n=234). Isolates were susceptibility tested by the CLSI broth microdilution method.

RESULTS:

Aztreonam-avibactam was the most active compound against isolates from all regions and infection types (MIC_50/90, 4/4 mg/L; 99.5% inhibited at ≤8 mg/L). The percentage of isolates inhibited at ≤8 mg/L varied from 99.3% in W-EU to 100.0% in APAC and LATAM. Trimethoprim-sulfamethoxazole (MIC_50/90, ≤0.12/0.5 mg/L; 95.6/96.3% susceptible per CLSI/EUCAST) and minocycline (MIC_50/90, 0.5/1 mg/L; 92.7% susceptible per CLSI) also were active. Aztreonam-avibactam remained active against trimethoprim-sulfamethoxazole-resistant isolates, inhibiting 100.0% at ≤8 mg/L.

CONCLUSIONS:

Aztreonam-avibactam may represent a valuable option to treat S. maltophilia infections, addressing a major unmet medical need.

项与阿维巴坦钠/氨曲南相关的新闻（医药）

2025-02-10

·药明康德

首款！FDA批准辉瑞/艾伯维小分子疗法

艾伯维（AbbVie）公司宣布，美国FDA已批准该公司与辉瑞（Pfizer）联合开发的Emblaveo（aztreonam和avibactam）上市，与甲硝唑联合使用，治疗18岁及以上复杂性腹腔内感染（cIAI）患者，包括由多种耐药性革兰氏阴性菌导致的感染。这些患者缺乏其它替代治疗方案。新闻稿指出，Emblaveo是FDA批准的首个固定剂量、静脉注射的单环β-内酰胺/β-内酰胺酶抑制剂组合抗生素。由于抗微生物药物耐药性（AMR）水平较高，革兰氏阴性菌感染是医疗专业人员最难控制的感染之一。AMR被视为一项紧迫的全球公共卫生威胁，仅在2021年，全球估计就有114万例死亡归因于AMR。如果AMR问题得不到解决，轻微感染和常规手术程序可能会变得危及生命甚至致命。 Emblaveo的批准得到了此前aztreonam在治疗cIAI方面疗效和安全性的研究结果的支持，同时也得到了3期临床试验REVISIT的临床试验结果支持，该研究评估了Emblaveo在治疗由革兰氏阴性菌引起的严重感染时的疗效、安全性和耐受性。此前公布的数据显示，Emblaveo对cIAI患者的治愈率为76.4%，而使用活性对照药物治疗患者的治愈率为74.0%。 Emblaveo是由一种单环β-内酰胺类抗生素aztreonam，和β-内酰胺酶抑制剂avibactam构成的组合抗生素。Avibactam能够保护aztreonam免受丝氨酸β-内酰胺酶的水解，并恢复其对同时产生金属β-内酰胺酶（MBLs）和丝氨酸β-内酰胺酶的细菌的活性。MBLs是某些细菌产生的一类酶，这些细菌可能因此对抗生素产生耐药性，而且其发生率正在全球范围内上升。 Emblaveo由辉瑞与艾伯维联合开发。辉瑞拥有在美国和加拿大以外地区商业化该疗法的全球权利，而艾伯维则拥有Emblaveo在美国和加拿大的权利。作为创新的赋能者、客户信赖的合作伙伴以及全球健康产业的贡献者，药明康德致力于通过其独有的CRDMO模式，以及其业内领先的感染性疾病新药研发赋能平台，助力全球共同应对AMR这一重大的健康威胁。早在2022年“即刻行动”药明康德健康产业论坛上，AMR就是我们重点关注的方向之一。在2024“世界提高微生物药物耐药性认识周”（World Antimicrobial Resistance Awareness Week）期间，药明康德内容团队就如何解决AMR这一研究健康挑战，分享了业界多位专家的洞见。其中，开发具有创新机制的抗生素，是多位专家提到的重要努力方向之一。期待更多创新抗生素早日获批上市，为解决AMR提供更多工具。参考资料： [1] U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options. Retrieved February 7, 2025, from https://www.prnewswire.com/news-releases/us-fda-approves-emblaveo-aztreonam-and-avibactam-for-the-treatment-of-adults-with-complicated-intra-abdominal-infections-with-limited-or-no-treatment-options-302371478.html 内容来源于网络，如有侵权，请联系删除。

上市批准微生物疗法

2025-02-09

·AIDD Pro

【第一百六十四期】AI+药物研发领域一周资讯

前言 AIDD Pro 根据国内外各大网站以及人工智能药物设计主流新闻网站及公众号，从 AIDD会议、AIDD招聘，重大科研进展、行业动态、最新报告发布等角度，分析挖掘了每周人工智能辅助药物设计领域所发生的、对领域技术发展产生重大推动作用的事件，旨在帮助 AIDD领域研究人员和业内人士及时追踪最新科研动态、洞察前沿热点。如果您觉得符合以上要求的内容我们有遗漏或者更好建议，欢迎后台留言。科研进展2025年2月7日【机器学习】J. Nat. Prod. | 基于机器学习的利用LC-MS/MS代谢组学对天然产物生物活性的分类2025年2月7日【分子模拟】Macromolecules | 通过分子模拟探究聚酯去结晶的分子细节2025年2月6日【图神经网络】J. Chem. Inf. Model. | CL-GNN：对比学习和图神经网络用于蛋白质配体结合亲和力预测2025年2月6日【药物发现】J. Med. Chem. | 人工智能在天然产物药物发现中的应用和未来展望2025年2月5日【靶向癌症治疗】ACS Nano | 载脂蛋白融合使mRNA脂质纳米颗粒与靶向癌症治疗的抗体自发功能化2025年2月5日【SARS-CoV-2】ACS Chem. Biol. | ML283 分子探针类似物是有效的 SARS-CoV-2 解旋酶抑制剂具体信息，请滑动下方文字 1.【机器学习】已知药物类别的再发现是天然产物药物发现中的一个重大挑战。化合物的再发现抑制了研究人员探索新的天然产物的能力，浪费了大量的时间和资源。本研究引入了一种新的机器学习框架，通过利用液相色谱串联质谱和非靶向代谢组学分析，可以有效地表征天然产物的生物活性。这通过解决先前发现的生物活性化合物去复制的挑战，加速了天然产物药物的发现。利用SIRIUS 5代谢组学软件套件和芯片生成的碎片谱，我们训练了一个能够预测化合物药物类别的ML模型。这种方法可以从LC-MS/MS数据中快速鉴定生物活性支架，即使没有参考实验光谱。该模型在SIRIUS 5生成的一组不同的分子指纹上进行训练，以有效地根据其核心药效团对化合物进行分类。我们的模型对21种不同的生物活性药物类别进行了稳健分类，在实验光谱上的准确率超过93%。该研究强调了ML与mfp结合的潜力，可以基于药效团复制生物活性天然产物，简化发现过程，加快分离新型抗菌和抗真菌药物的改进方法。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acs.jnatprod.4c01123 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acs.jnatprod.4c01123 2.【分子模拟】废聚酯是回收和升级利用产品的潜在原料。这些聚合物通常是半结晶的，这对单体的化学和生物回收提出了挑战，因此与聚酯脱晶相关的热力学工作是一些解聚策略的重要考虑因素。在这里，我们使用分子动力学模拟来计算五种具有商业和科学意义的半芳香聚酯（PET， PTT， PBT， PEN和PEF）在水中从晶体表面脱晶单链所需的自由能。我们的结果表明，晶体表面中间链的脱晶功在每个重复单元大约15到8千卡/摩尔（PEF）之间。对形成半晶合成聚酯结构基础的分子相互作用的洞察可以指导追求更高效的塑料加工，包括催化剂开发，优化回收条件，包括预处理，酶和溶剂的选择，以及新材料的设计。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acs.macromol.4c02130 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acs.macromol.4c02130 3.【图神经网络】在药物发现和设计领域，准确预测蛋白质-配体结合亲和力至关重要，因为它是生物系统内功能相互作用的基础。本研究引入了一种新的自监督学习（SSL）框架，该框架结合了对比学习和图神经网络（CL-GNN），用于预测蛋白质-配体结合亲和力，这是药物发现的关键方面。传统的亲和预测方法既昂贵又耗时，因此需要开发更高效的计算方法。CL-GNN利用对比学习策略（SSL的一种形式）从371 458个独特的未标记蛋白质配体复合物的大数据集中学习。通过使用图神经网络和分子图增强技术，该模型以自监督的方式有效地捕获蛋白质-配体相互作用。经过微调的模型展示了具有竞争力的性能，在基准数据集上实现了高Pearson相关系数和低均方根误差。所提出的方法优于现有的机器学习模型，展示了其加速药物开发过程的潜力。该方法通过余弦相似性评估有效地量化了在预训练和下游测试阶段学习到的蛋白质-配体复合物表征之间的相似性。该方法不仅揭示了复合物之间结合特性的潜在联系，而且为理解药物作用机制提供了新的见解。此外，通过可视化关键蛋白质残基和配体原子的重要性，显著提高了模型的透明度。该可视化工具提供了对模型预测决策过程的洞察，为药物设计和优化提供了关键的生物学见解。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acs.jcim.4c01290 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acs.jcim.4c01290 4.【药物发现】从化合物鉴定到监管批准，药物发现是一个多方面的过程，由于数据利用率有限，历史上一直受到效率低下和时间滞后的困扰，现在迫切需要加速先导化合物鉴定。生物数据和计算化学的创新刺激了药物化学从试错法到整体方法的转变。计算技术，特别是人工智能（AI），特别是机器学习（ML）和深度学习（DL），已经彻底改变了药物开发，增强了数据分析和预测建模。天然产物（NPs）长期以来一直是生物活性化合物的丰富来源，许多成功的药物都源于它们。信息科学的进步扩展了np相关数据库，使人工智能能够进行更深入的探索。将人工智能集成到NP药物发现中有望加速发现，利用人工智能的分析能力，包括用于数据合成的生成人工智能。这一观点阐明了人工智能在NP药物发现中的现状，解决了这一重要研究领域的优势、局限性和未来发展轨迹。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acs.jmedchem.4c01257 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acs.jmedchem.4c01257 5.【靶向癌症治疗】 mRNA-脂质纳米颗粒（mRNA@LNPs）提供了一个新的机会来治疗以前认为不可药物的目标。虽然抗体偶联对于提高mRNA治疗的特异性、传递效率和最小化毒性至关重要，但目前的化学偶联方法很复杂，并且会产生带有错误定向抗体的异质颗粒。在这项工作中，我们引入了一种无化学物质的方法，用抗体功能化mRNA@LNPs，模拟蛋白冠的形成，以实现靶向mRNA的传递。通过将载脂蛋白融合到靶向抗体的Fc结构域，我们使抗体自发地在mRNA@LNPs表面显示，而不改变现有的LNP过程或使用复杂的化学偶联技术。我们使用曲妥珠单抗结合mRNA@LNPs证明了精确的蛋白表达，促进了her2阳性癌细胞中特异性mRNA的表达。经静脉给药后，mRNA有效地传递到肿瘤部位。而缺乏靶向抗体的对照LNPs引起急性肝毒性，曲妥珠单抗显示LNPs没有全身毒性。p53肿瘤抑制mRNA的肿瘤特异性传递导致癌细胞完全消退。因此，载脂蛋白融合可以直接和可扩展地生产抗体功能化mRNA@LNPs，在基因治疗中提供重要的治疗潜力。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acsnano.4c16562 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acsnano.4c16562 6.【SARS-CoV-2】美国国立卫生研究院分子探针ML283是一种有效的、选择性的丙型肝炎病毒解旋酶抑制剂。由于AutoDock Vina模型预测ML283可能结合严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）非结构蛋白13 （nsp13）解旋酶，因此分析了ML283类似物和其他丙型肝炎病毒（HCV）解旋酶抑制剂对SARS-CoV-2解旋酶的影响。一些化合物对nsp13催化的ATP水解只有轻微的影响，其中大多数是药物埃布selen的类似物，而不是ML283。相比之下，一项新的基于分子信标的解旋酶检测显示，ML283和许多ML283类似物是有效的SARS-CoV-2解旋酶抑制剂。模拟电位与模型预测的结合能相关，这表明由羧基末端nsp13 reca样解旋酶马达结构域包围的口袋可能用于抗病毒药物的开发。链接网址：https://pubs-acs-org.libproxy1.nus.edu.sg/doi/10.1021/acschembio.4c00458 DOI：https://doi-org.libproxy1.nus.edu.sg/10.1021/acschembio.4c00458 上下滚动查看更多药企动态2025年2月8日【辉瑞】首款！FDA今日批准辉瑞/艾伯维小分子疗法2025年2月7日【康诺亚】康诺亚：全球首个季节性过敏性鼻炎IL-4Rα生物制剂康悦达®（司普奇拜单抗）获批上市2025年2月7日【科伦博泰】国内首个！科伦博泰西妥昔单抗生物类似药获批上市2025年2月6日【百时美施贵宝】百时美施贵宝终止开发III期IL-13抗体2025年2月5日【复宏汉霖】复宏汉霖PD-1单抗在欧盟获批上市2025年2月5日【信达生物】信达生物 PD-1 联合疗法拟纳入优先审评各动态具体信息，请滑动下方文字 1.【辉瑞】艾伯维（AbbVie）公司今日宣布，美国FDA已批准该公司与辉瑞（Pfizer）联合开发的Emblaveo（aztreonam和avibactam）上市，与甲硝唑联合使用，治疗18岁及以上复杂性腹腔内感染（cIAI）患者，包括由多种耐药性革兰氏阴性菌导致的感染。这些患者缺乏其它替代治疗方案。新闻稿指出，Emblaveo是FDA批准的首个固定剂量、静脉注射的单环β-内酰胺/β-内酰胺酶抑制剂组合抗生素。链接网址请戳我 2.【康诺亚】 2025年2月7日，康诺亚宣布，公司自主研发的1类新药康悦达®（司普奇拜单抗注射液）获国家药品监督管理局批准上市，用于治疗季节性过敏性鼻炎（SAR）。链接网址请戳我 3.【科伦博泰】 2月7日，国家药品监督管理局（NMPA）官网显示，科伦博泰的生物类似药EGFR单抗西妥昔单抗N01注射液（A140）的上市申请已获得批准。根据科伦博泰此前的新闻稿披露，该药的拟定适应症为：本品用于治疗RAS基因野生型的转移性结直肠癌：与奥沙利铂（FOLFOX）或伊立替康（FOLFIRI）方案联合用于一线治疗；与FOLFIRI联合用于经含FOLFIRI治疗失败后的患者；本品用于治疗头颈部鳞状细胞癌：与铂类和氟尿嘧啶化疗联合用于一线治疗复发和/或转移性疾病；与放疗联合用于治疗局部晚期疾病。链接网址请戳我 4.【百时美施贵宝】2月6日，百时美施贵宝（BMS）在发布2024年业绩时透露，决定终止开发已经进入III期阶段的IL-13单抗Cendakimab。在BMS 2024年报PPT中已不见Cendakimab的身影。链接网址请戳我 5.【复宏汉霖】 2月5日，复宏汉霖宣布抗PD-1单抗汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）正式获得欧盟委员会（EC）批准，联合卡铂和依托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，标志着汉斯状成为全球首个获批上市用于广泛期小细胞肺癌治疗的抗PD-1单抗。链接网址请戳我 6.【信达生物】 2月5日，CDE 官网公示，信达生物申报的「信迪利单抗注射液」和「伊匹木单抗注射液」拟被纳入优先审评，适应症为两药联合用于可切除的微卫星高度不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌患者的新辅助治疗。链接网址请戳我上下滚动查看更多会议信息 2025年3月27-28日上海恺默信息咨询有限公司举办SIT 2025第七届小分子药物创新峰会 2025年6月27-28日美国华人生物医药科技协会中国分会（CBA-China）主办，苏州云程万川（盛杰）承办2025美国华人生物医药科技协会CBA-China中国年会各会议具体详情和参会方式，请滑动下方文字 SIT 2025第七届小分子药物创新峰会主办方：上海恺默信息咨询有限公司会议时间：2025年3月27-28日会议地点：上海会议主旨：聚焦减重药物的突破性研究、多肽药物的最新进展以及不可成药靶点的攻克。将深入探讨小分子药物的创新路径，分享业内最前沿的技术与策略。共同探索小分子药物的无限可能，携手推动药物研发领域的持续进步。链接网址请戳我 22025美国华人生物医药科技协会CBA-China中国年会主办方：美国华人生物医药科技协会中国分会会议时间：2025年6月27-28日会议地点：苏州会议主旨：立足国际视野及产业高度，以创新为引领，围绕全球最新监管动态、新技术/AI革新及成果转化、先进治疗技术、药物创新开发、全球药物开发策略、新兴市场出海布局等前沿热门话题，共同探索前沿技术创新与全球医药合作，促进新质生产力培育及未来产业发展，推动全球健康事业新发展。链接网址请戳我上下滚动查看更多版权信息本文内容均由小编收集于公开的各个网络平台，发布的目的仅为了方便大家一站式了解AIDD行业信息，并未对发布源头进行真实性验证。如您发现相关信息有任何版权侵扰或者信息错误，请及时联系AIDD Pro（请添加微信号sixiali_fox59）进行删改处理。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至sixiali@stonewise.cn 关注我，更多资讯早知道↓↓↓

信使RNA临床1期

2025-02-08

·EndPoints

AbbVie wins FDA approval for new antibiotic to treat complex intra-abdominal infections

The FDA approved AbbVie and Pfizer’s drug Emblaveo in combination with an older antibiotic to treat complicated intra-abdominal infections. AbbVie, which owns the US commercial rights to the antibiotic, said in its announcement Friday that the covered infections include those caused by Gram-negative microorganisms, which can develop resistance to drugs. “The approval of Emblaveo provides physicians a much-needed therapeutic option to help address some of the most difficult antimicrobial-resistant pathogens and provides doctors an opportunity to treat patients with these challenging infections,” James McKinnell, an infectious disease doctor at California’s Torrance Memorial Physician Network, said in the company’s press release. The treatment received a Qualified Infectious Disease Product (QIDP) designation from the FDA in 2019. The QIDP tag is meant to incentive companies to develop new antibiotics and provides priority review, eligibility for Fast Track Designation (which the treatment received) and a five-year regulatory exclusivity extension. AbbVie said Emblaveo will be available in the third quarter. It didn’t disclose a price. The antibiotic was jointly developed with Pfizer, which holds global commercial rights outside of the US and Canada. The program also received government assistance through the Biomedical Advanced Research and Development Authority (BARDA) in the US and the EU’s Innovative Medicines Initiative. The European Commission approved Emblaveo in April 2024.

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适应症	国家/地区	公司	日期
复杂腹腔感染	欧盟	Pfizer Inc.	2024-04-22
复杂腹腔感染	冰岛	Pfizer Inc.	2024-04-22
复杂腹腔感染	列支敦士登	Pfizer Inc.	2024-04-22
复杂腹腔感染	挪威	Pfizer Inc.	2024-04-22
复杂的尿路感染	欧盟	Pfizer Inc.	2024-04-22
复杂的尿路感染	冰岛	Pfizer Inc.	2024-04-22
复杂的尿路感染	列支敦士登	Pfizer Inc.	2024-04-22
复杂的尿路感染	挪威	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	欧盟	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	冰岛	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	列支敦士登	Pfizer Inc.	2024-04-22
革兰氏阴性菌感染	挪威	Pfizer Inc.	2024-04-22
医院获得性肺炎	欧盟	Pfizer Inc.	2024-04-22
医院获得性肺炎	冰岛	Pfizer Inc.	2024-04-22
医院获得性肺炎	列支敦士登	Pfizer Inc.	2024-04-22
医院获得性肺炎	挪威	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	欧盟	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	冰岛	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	列支敦士登	Pfizer Inc.	2024-04-22
呼吸机相关性肺炎	挪威	Pfizer Inc.	2024-04-22

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适应症	最高研发状态	国家/地区	公司	日期
细菌感染	临床3期	美国	Pfizer Inc.	2020-12-25
细菌感染	临床3期	美国	Allergan Ltd. (Ireland)	2020-12-25
细菌感染	临床3期	中国	Allergan Ltd. (Ireland)	2020-12-25
细菌感染	临床3期	中国	Pfizer Inc.	2020-12-25
细菌感染	临床3期	阿根廷	Pfizer Inc.	2020-12-25
细菌感染	临床3期	阿根廷	Allergan Ltd. (Ireland)	2020-12-25
细菌感染	临床3期	希腊	Pfizer Inc.	2020-12-25
细菌感染	临床3期	希腊	Allergan Ltd. (Ireland)	2020-12-25
细菌感染	临床3期	印度	Allergan Ltd. (Ireland)	2020-12-25
细菌感染	临床3期	印度	Pfizer Inc.	2020-12-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03329092 (REVISIT, Pubmed \| Lancet Infect Dis)	临床3期	革兰氏阴性菌感染 Gram-negative bacteria	422	Aztreonam-avibactam	糧膚蓋簾醖艱膚鏇膚醖(齋範齋築構壓築製淵淵) = 壓積餘襯憲壓網膚獵鬱鹹襯鬱選膚夢蓋選夢艱 (齋餘憲築鹽鬱鏇膚遞製 ) 更多	积极	2024-10-01
				Meropenem	糧膚蓋簾醖艱膚鏇膚醖(齋範齋築構壓築製淵淵) = 構壓鑰衊憲鏇積繭醖簾鹹襯鬱選膚夢蓋選夢艱 (齋餘憲築鹽鬱鏇膚遞製 ) 更多
NCT03329092 (REVISIT, CTgov)	临床3期	革兰氏阴性菌感染 \| 复杂腹腔感染 \| 呼吸机相关性肺炎 ... 更多	422	MTZ+ATM-AVI	選築願觸憲鏇簾簾膚夢(壓鹹構廠鑰糧製築網鏇) = 醖選憲餘窪衊餘顧繭顧壓顧蓋憲鏇觸顧繭膚膚 (繭淵遞糧窪簾鑰襯鬱襯, 製襯顧網襯繭願夢齋鑰 ~ 鹹膚觸憲網遞蓋鹽膚憲) 更多	-	2024-05-07
NCT03580044 (CTgov)	临床3期	细菌感染	15	Avibactam (ATM- AVI+Aztreonam (Aztreonam- Avibactam (ATM- AVI))	顧餘壓鹽淵醖製顧淵築(糧淵遞積憲遞鏇壓選齋) = 簾築鬱壓顧壓遞壓壓淵艱艱壓繭憲齋膚壓夢製 (蓋積遞廠遞淵糧憲鬱製, 醖獵醖觸獵膚網齋獵餘 ~ 構餘積網淵鹽艱選窪繭) 更多	-	2024-02-02
				metronidazole (Best Available Therapy (BAT))	顧餘壓鹽淵醖製顧淵築(糧淵遞積憲遞鏇壓選齋) = 糧夢醖膚鏇壓鏇夢襯齋艱艱壓繭憲齋膚壓夢製 (蓋積遞廠遞淵糧憲鬱製, 觸蓋廠鹹繭壓鬱鏇醖壓 ~ 範願窪獵衊遞艱膚構齋) 更多
NCT04973826 (CTgov)	临床1期	-	12	AVIBACTAM (ATM-AVI+AZTREONAM	餘淵淵顧築夢襯繭膚鏇(鹽襯簾餘齋窪鑰選積淵) = 淵顧鏇衊餘觸醖製淵齋衊選鏇網網襯襯範網鹹 (繭糧夢願齋齋襯顧壓簾, 顧獵壓網齋鑰鬱網製壓 ~ 齋構製壓鏇構糧壓淵願) 更多	-	2023-07-28
NCT04486625 (CTgov)	临床1期	肾功能不全	11	ATM (Cohort 1: Normal Renal Function)	膚鏇遞積鹽艱鬱醖餘構(膚網構鹹齋夢築鑰網鬱) = 衊製製壓鏇蓋憲範顧構願鹽簾壓窪網鬱構蓋鑰 (鏇遞襯遞繭鹹鹹齋鏇壓, 構壓蓋壓鏇選範餘願蓋 ~ 齋膚鬱獵壓簾膚夢艱鬱) 更多	-	2023-07-28
				ATM (Cohort 2: Severe Renal Impairment)	膚鏇遞積鹽艱鬱醖餘構(膚網構鹹齋夢築鑰網鬱) = 餘選構齋壓憲鑰衊襯繭願鹽簾壓窪網鬱構蓋鑰 (鏇遞襯遞繭鹹鹹齋鏇壓, 選餘憲鑰餘獵構顧願壓 ~ 鬱艱構願簾窪艱鑰艱餘) 更多
NCT02655419 (Pubmed \| BMJ Open)	临床2期	复杂腹腔感染	40	aztreonam-avibactam (Hospitals 3 and 6)	餘衊鬱積積鑰築壓襯襯(蓋網齋獵築鑰鑰窪鬱憲) = 觸餘鑰鬱餘顧蓋窪觸構鏇夢網顧憲壓鏇憲壓鏇 (襯鏇構觸艱憲艱蓋憲網 )	-	2022-02-03
NCT02655419 (CTgov)	临床2期	复杂腹腔感染	40	AVI+Metronidazole (ATM-AVI+ Metronidazole:Low AVI Dose Cohort)	窪構窪構窪鹹窪繭鹹艱(製衊鏇範餘襯膚夢遞範) = 蓋齋遞憲觸蓋構蓋廠糧衊齋觸餘鹽襯醖艱網壓 (願範鬱製獵壓糧夢襯廠, 網蓋蓋觸顧窪範範遞選 ~ 衊觸膚範範艱鹽鏇夢網) 更多	-	2019-03-04
				AVI+Metronidazole (ATM-AVI + Metronidazole: High AVI Dose Cohort)	糧膚夢網廠繭襯繭願簾(襯衊夢顧築淵鬱鏇積網) = 簾襯遞簾繭艱鏇顧積壓獵製觸觸積顧網積淵齋 (簾淵餘網醖廠顧繭壓襯, 製鹽鏇願憲淵壓衊廠獵 ~ 齋鬱壓醖淵築獵壓齋遞) 更多