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2024-09-16

申办/合作机构

Pfizer Inc.

[+1]

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.

NCT04973826 / Completed临床1期

A PHASE I, SINGLE CENTER, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM ADMINISTERED AS SINGLE AND REPEATED INTRAVENOUS DOSES IN HEALTHY CHINESE PARTICIPANTS

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.

开始日期2021-08-20

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/氨曲南相关的转化医学

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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）

2024-09-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Resistance to aztreonam-avibactam among clinical isolates of Escherichia coli is primarily mediated by altered penicillin-binding protein 3 and impermeability

Article

作者: Peris, Pol Saludes ; Jonsson, Patrik ; Razavi, Mohammad ; Tellapragada, Chaitanya ; Vondracek, Martin ; Giske, Christian G

This study was conducted to investigate decreased susceptibility (minimum inhibitory concentrations [MICs] 0.25-4 mg/L) and resistance (MICs > 4 mg/L) to aztreonam-avibactam (ATM-AVI). Contemporary non-replicate clinical isolates of carbapenemase-producing Escherichia coli (CP-EC) (n=90) and ESBL-producing E. coli (EP-EC) (n=12) were used. CP-EC belonged to 25 distinct sequence types (STs) and all EP-EC belonged to ST405. All strains were isolated from 2019 to 2022 at the Karolinska University Laboratory, Stockholm, Sweden. ATM-AVI MICs were determined using broth microdilution. The EUCAST epidemiological cut-off value of 0.125 mg/L was used to define the wild type (WT). Whole-genome sequences (Illumina) were analysed for detecting resistance determinants among WT vs. non-WT isolates. Among 102 isolates, 40 (39%) and 62 (61%) were WT and non-WT, respectively. Among non-WT isolates, resistance was noted for 20 and decreased susceptibility for 42. Resistance was observed among 14/47 New Delhi metallo-β-lactamase (NDM)-producers, 5/43 OXA-48 group producers, and 1/12 EP-EC. Decreased susceptibility was observed among 29/47 NDM, 13/43 OXA-48 group, and 3/12 EP-EC. Resistant isolates predominantly belonged to ST405, followed by STs 410, 361, 167, 617, and 1284. Penicillin-binding protein 3 (PBP3) inserts (YRIK/YRIN) were observed in 20/20 and CMY-42 in 5/20 resistant isolates. Several mutations in the ftsI (encoding PBP3) and regulatory genes of outer membrane proteins (OmpC and OmpF) and efflux pumps (AcrAB-TolC) were detected. A ≥ 2-fold reduction in MICs was observed among 20/20 vs. 7/20 isolates tested in the presence of the membrane permeabiliser, polymyxin B nanopeptide (PMBN) and efflux inhibitor, phenylalanine arginine β-naphthylamide (PAβN), respectively. In conclusion, resistance to ATM-AVI is a result of interplay of various determinants, including target alterations, deactivating enzymes, and decreased permeability.

2024-07-01·Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy

Ceftazidime-avibactam in the treatment of bacteremia due to carbapenem-resistant gram-negative bacteria in hematological patients: Experience in a single center

Article

作者: Wang, Jianxiang ; Zhang, Rongli ; Yang, Donglin ; Lin, Qingsong ; He, Yi ; Chen, Xin ; Zhai, Weihua ; Feng, Sizhou ; Jiang, Erlie ; Ma, Qiaoling ; Zhen, Sisi ; Pang, Aiming ; Chen, Zhangjie ; Wei, Jialin ; Shen, Yuyan ; Han, Mingzhe

INTRODUCTION:

Limited experience exists with ceftazidime-avibactam (CAZ-AVI) in treating bacteremia caused by carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa (CRPA) in hematological patients.

METHODS:

We performed a single-center, retrospective, observational study including patients who received CAZ-AVI for bacteremia due to CRE or CRPA between 2018 and 2022. The primary outcome was 30-day survival. We conducted a multivariable analysis to identify predictors of survival.

RESULTS:

56 patients were included and 57 (41 CRE and 16 CRPA) strains were isolated. 35 strains produced carbapenemase, including 25 metallo-beta-lactamase (MBL) and 10 serine-beta-lactamase. 48 patients (85.7 %) received combination therapy. All patients with MBL-CRE bacteremia (n = 24) received combination therapy with aztreonam (AZT). The susceptibility rates to CAZ-AVI were only 26.8 % (11/41) in CRE and 80.0 % (8/10) in CRPA. The 30-day survival rates were 85.0 % (34/40) in the CRE group and 81.3 % (13/16) in the CRPA group. In patients with MBL-CRE bacteremia, the 30-day survival was as high as 91.7 % (22/24) due to combination with AZT. Ceftazidime did not influence the activity of aztreonam-avibactam against MBL-CRE in-vitro. Multivariable cox analysis revealed neutropenia >14 days (P = 0.002, HR: 34.483, 95%CI: 3.846-333.333) and a higher Pitt bacteremia score (P = 0.005, HR: 2.074, 95%CI: 1.253-3.436) were risk factors for 30-day survival.

CONCLUSIONS:

CAZ-AVI is highly effective in treating bacteremia due to CRPA and serine-beta-lactamase CRE. The combination of avibactam with AZT is highly effective in treating bacteremia due to AZT-resistant MBL producers.

2024-07-01·MICROBIAL PATHOGENESIS

Emergence of aztreonam/avibactam and tigecycline-resistant Pseudomonas putida group Co-producing blaIMP-1, blaAFM-4 and blaOXA-1041 with a novel sequence type ST268 in Southwestern China

Article

作者: Jian, Chunxia ; Guo, Tongtong ; Liu, Jinbo ; Zeng, Zhangrui ; Hao, Jingchen ; Ding, Yinhuan ; Ye, Caihong ; Xiao, Xue ; Xie, Wenchao

OBJECTIVES:

The emergence of carbapenem-resistant Pseudomonas putida (CRPP) has raised public awareness. This study investigated two strains from the Pseudomonas putida group that were resistant to carbapenem, tigecycline, and aztreonam-avibactam (ATM-AVI), with a focus on their microbial and genomic characteristics.

METHODS:

We assessed the antibiotic resistance profile using broth dilution, disk diffusion, and E-test methods. Efflux pump phenotype testing and real-time quantitative PCR were employed to evaluate efflux pump activity in tigecycline resistance, while polymerase chain reaction was utilized to detect common carbapenem genes. Additionally, whole-genome sequencing was performed to analyze genomic characteristics. The transferability of bla_IMP-1 and bla_AFM-4 was assessed through a conjugation experiment. Furthermore, growth kinetics and biofilm formation were examined using growth curves and crystal violet staining.

RESULTS:

Both strains demonstrated resistance to carbapenem, tigecycline, and ATM-AVI. Notably, NMP can restore sensitivity to tigecycline. Subsequent analysis revealed that they co-produced bla_IMP-1, bla_AFM-4, tmexCD-toprJ, and bla_OXA-1041, belonging to a novel sequence type ST268. Although they were closely related on the phylogenetic tree, they exhibited different levels of virulence. Genetic environment analysis indicated variations compared to prior studies, particularly regarding the bla_IMP-1 and bla_AFM-4 genes, which showed limited horizontal transferability. Moreover, it was observed that temperature exerted a specific influence on their biological factors.

CONCLUSION:

We initially identified two P. putida ST268 strains co-producing bla_IMP-1, bla_AFM-4, bla_OXA-1041, and tmexCD-toprJ. The resistance to tigecycline and ATM-AVI can be attributed to the presence of multiple drug resistance determinants. These findings underscore the significance of P. putida as a reservoir for novel antibiotic resistance genes. Therefore, it is imperative to develop alternative antibiotic therapies and establish effective monitoring of bacterial resistance.

项与阿维巴坦钠/氨曲南相关的新闻（医药）

2024-05-23

·美通社

Access to Medicine Foundation的新报告显示，制药公司可以采取哪些措施来确保处于耐药性前线的患者能够获得正在开发的少数有前途的抗微生物药物

阿姆斯特丹 2024年5月23日 /美通社/ -- 开发替代抗生素和抗真菌药物来对抗超级细菌的竞赛严重不足，使世界各地的人们处于危险之中。但是，研发（R&D）的转变，包括对准入和管理规划的投资，可以对抗微生物药物耐药性（AMR）产生重大影响。由于大多数以研究为基础的大型制药公司不再活跃于抗微生物药物研发，因此上市的新疗法很少，这使得患者容易受到抗微生物药物耐药性快速传播的影响。尽管存在这种现实，但少数处于后期临床开发阶段的项目可能会产生重大影响。 A ccess to Medicine Foundation的新报告追踪了葛兰素史克、F2G、Innoviva、Venatorx（分别为gepotidacin、olorofim、zoliflodacin和cefepime-taniborbactam）和辉瑞最近批准的阿曲南阿维巴坦（Emblaveo®）管道中的五个此类项目。通过提供急需的药物来治疗耐药性淋病、尿路感染、腹腔内感染、呼吸道感染和侵入性真菌感染，这些项目每年总共可以挽救至少16万人的生命。尽管这些疾病影响着全球范围广泛的患者，但妇女和儿童，尤其是生活在低收入和中等收入国家（LMIC）的妇女和儿童，受到的影响尤其严重。 "在抗击耐药感染的竞赛中，我们的武器规模虽小但有效。我们在这场竞赛中获胜与失败的区别取决于公司如何为生活在耐药前线的人们提供机会。" — 医学准入基金会首席执行官贾亚斯里•艾耶。调查结果显示，各公司在其准入和管理计划中采用了多种策略，但结构化的预先计划尚未成为标准。令人鼓舞的是，在范围内的五家公司中，有四家——葛兰素史克、辉瑞、Innoviva和Venatorx——正在进行或启动直接针对儿童的临床试验，这表明在缩小成人和儿科准入差距方面取得了进展。五个低收入国家确定了注册承诺：中国、印度、墨西哥、南非和泰国。但是，对于范围内的113个中低收入国家中的108个，人们也面临着这些项目针对的疾病的沉重负担，目前尚不清楚在初步批准后是否会提供这些项目。该报告为重点公司确定了机遇和建议，并概述了全球利益相关者在抗微生物药物研发领域的可行措施，以促进广泛采用预先准入和管理规划。 "应对耐药性的巨大规模和速度是一个复杂的全球健康问题，需要制药公司在多个领域采取行动。这包括提供适当的准入和实施管理措施，以保障创新抗微生物药物的有效性。不这样做将限制解决耐药性的努力。"——准入医学基金会运营与研究总监玛丽恩•维尔霍夫。在全球卫生利益相关者为2024年联合国大会抗菌素耐药性高级别会议做准备之际，本报告是在关键时刻发布的，强调了需要注意的紧迫差距。在这里阅读报告。

微生物疗法临床研究

2024-05-23

·Outsourcing Pharma

What can pharma companies do to get promising antimicrobials to the frontlines of drug resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As most large research-based pharmaceutical companies are no longer active in antimicrobial research and development (R&D), there are very few new treatments making it to market, leaving patients vulnerable to the rapid spread of AMR. Despite this reality, a handful of projects in late-stage clinical development could have a significant impact. Difficult-to-treat invasive, rare fungal mold infections The foundation is tracking five drugs which include gepotidacin, a small molecule commercialized by GSK with a leading phase 3 program in urinary tract infections and F2G’s olorofim, a first of the new orotomide class of antifungals in development for the treatment of difficult-to-treat invasive, rare fungal mold infections. Innoviva’s zoliflodacin is another treatment being tracked and is said to be one of the most promising new treatments for gonorrhoeae currently in phase 3 clinical trials. According to a report in Nature Scientific Reports, studies have found very little resistance to the drug currently circulating in strains, and in-vitro experiments demonstrated that it is difficult to induce resistance. Venatorx’s cefepime-taniborbactam is also under the foundation’s radar. The beta-lactam/beta-lactamase inhibitor (BL/BLI) combination antibiotic is being developed for the treatment of complicated urinary tract infections and hospital acquired bacterial pneumonia. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Pfizer's recently approved aztreonam-avibactam (Emblaveo) is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant gram-negative bacteria, including metallo-β-lactamase-producing bacteria. Emblaveo was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation. People living on the frontlines of drug resistance Collectively, these projects could save at least 160,000 lives annually by providing much-needed medicines to treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections, and invasive fungal infections. While these diseases affect a wide range of patients globally, women and children- especially those living in low-and middle-income countries (LMICs)- are disproportionately affected. Jayasree Iyer, CEO, at the Access to Medicine Foundation, said: “We have a small, but effective, arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance.” The foundation said that findings reveal that companies are employing diverse range of strategies within their access and stewardship plans but structured advance planning has not yet become standard. Encouragingly, it said, four of the five companies in scope, GSK, Pfizer, Innoviva, and Venatorx, are conducting or initiating clinical trials that directly target children, signalling progress in closing the gap between adult and paediatric access. Tackling the sheer scale and pace of drug resistance Commitments for registration were identified in five LMICs: China, India, Mexico, South Africa, and Thailand. However, for 108 of 113 LMICs in scope, where people also face high burdens of the diseases targeted by these projects, it is currently unclear whether any of them will be made available upon initial approval. The report identifies opportunities and recommendations for companies in focus and outlines actionable steps for global stakeholders in antimicrobial R&D to promote widespread adoption of advance access and stewardship planning. Marijn Verhoef, director of operations and research, at the Access to Medicine Foundation, said: “Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance.” The foundation added that as global health stakeholders prepare for 2024 UN General Assembly's High-level Meeting on AMR, this report comes at a crucial moment, emphasising the urgent gaps that need attention.

临床3期上市批准

2024-05-21

·医药观澜

全球TOP 10最具创新力药企名单出炉，恒瑞医药上榜！

▎药明康德内容团队编辑日前，IDEA Pharma公司发布了评估医药公司将创新科研成果和技术成功转化，开发出早期产品能力的榜单。在这份医药发明指数（Pharmaceutical Invention Index）榜单中，强生、默沙东和阿斯利康位居前三，表示这些公司研发管线中新型在研药物的数量表现出显著增长。值得一提的是，恒瑞医药也在今年荣登TOP 10榜单。今天这篇文章，药明康德内容团队将与读者分享榜单的精彩内容，并对上榜公司的最新研发进展进行介绍。点击文末“阅读全文/Read more”，即可访问IDEA Pharma网站，浏览榜单详细内容。药明康德内容团队根据参考资料[2]制图强生强生在近期获得多项研发与管线扩展进展。这个月初，强生公布其在研膀胱内靶向释放疗法TAR-210用于治疗高危（HR）非肌层浸润性膀胱癌（NMIBC）患者的1期试验积极结果。在21名HR-NMIBC患者中，12个月无复发生存率高达90%。此外，强生也在这个月与治疗免疫介导疾病的生物技术公司Proteologix达成8.5亿美元的收购协议，囊获其靶向IL-13和TSLP的双特异性抗体PX128用以治疗中度至重度特应性皮炎。今年4月美国FDA批准强生与传奇生物（Legend Biotech）联合开发的CAR-T疗法Carvykti（ciltacabtagene autoleucel）用于二线治疗复发性或难治性（R/R）多发性骨髓瘤（MM）成年患者。今年3月，该公司与Idorsia联合开发的Tryvio（aprocitentan）口服片剂获FDA批准与其他抗高血压药物联合，用以治疗成年高血压患者。根据新闻稿，这款药物是30年来首个获批基于新机制的降血压药物。此外，强生也在今年1月通过收购Ambrx Biopharma囊获多款临床期抗体偶联药物（ADC）。默沙东今年5月，默沙东的重磅PD-1抑制剂Keytruda再度传来好消息，该疗法在3期临床试验中达到主要终点，与抗HER2抗体曲妥珠单抗和化疗联用，作为一线疗法治疗HER2阳性，不可切除的局部晚期或转移性胃癌或胃食管结合部（GEJ）腺癌患者时，能够显著延长患者的总生存期。除了持续推动Keytruda的开发，默沙东也在今年3月迎来其“first-in-class”疗法Winrevair（sotatercept）用于治疗肺动脉高压（PAH）的批准。这款疗法被行业媒体Evaluate评为2024年潜在重磅的疗法之一。该公司与Moderna联合开发的个体化新抗原疫苗mRNA-4157目前已有三项临床3期试验进行中，分别用以治疗经手术切除的黑色素瘤、非小细胞肺癌与皮肤鳞状细胞癌患者。而在今年的美国癌症研究协会大会上，默沙东与科伦博泰（Kelun-Biotech）公布其所联合开发Trop2靶向ADCSKB264治疗经治晚期胃癌或GEJ癌患者的疾病控制率（DCR）达80.5%。阿斯利康阿斯利康近期最引人瞩目之一的进展便是其与第一三共（Daiichi Sankyo）联合开发的重磅抗体偶联药物Enhertu（trastuzumab deruxtecan）获加速批准用于治疗不可切除或转移性HER2阳性实体瘤成年患者。根据新闻稿，Enhertu是首款具有不限癌种适应症的HER2靶向ADC疗法。目前该公司与第一三共联合开发的一款Trop2靶向ADC疗法datopotamab deruxtecan也已向FDA递交上市申请，用于治疗无法切除或转移性HR阳性、HER2阴性乳腺癌成人患者。此外，该公司的“first-in-class”口服小分子Voydeya（danicopan）也在今年3月获批治疗PNH患者。除了积极推动公司内部管线外，阿斯利康也在2023年11月与Cellectis公司达成战略合作，将共同合作加速多达10项的下一代细胞与基因疗法开发。百时美施贵宝百时美施贵宝分别在今年3月与5月迎来其CAR-T疗法Breyanzi（lisocabtagene maraleucel）用于治疗R/R慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL），与滤泡性淋巴瘤（FL）的扩展适应症批准。该公司的另一款CAR-T细胞疗法Abecma（idecabtagene vicleucel）也在近期获批用以治疗R/R多发性骨髓瘤。此外，美国FDA在今年2月亦接受KRAS G12C抑制剂Krazati（adagrasib）与西妥昔单抗（cetuximab）联合用以治疗肿瘤带有KRAS G12C突变的经治结直肠癌的补充新药申请（sNDA）并授予该申请优先审评资格。同月，其ROS1和NTRK靶向抑制剂Augtyro（repotrectinib）用以治疗实体瘤的sNDA也获优先审评资格。这两项sNDA皆预计将于今年6月获得审评结果。该公司通过收购Karuna Therapeutics所获得的潜在“first-in-class”疗法KarXT也有望在今年9月获批，成为数十年来用于治疗精神分裂症的首个新机制药物。此外，百时美施贵宝也在这个月初与Editas Medicine延长已有的研发合作，共同开发用于治疗癌症和自身免疫疾病的自体和异体α-β T细胞药物。Moderna今年4月，Moderna在《自然》杂志上发表了其用于治疗丙酸血症（PA）的在研mRNA疗法mRNA-3927的首个临床试验结果。分析显示，mRNA-3927表现出良好的安全性和耐受性，接受mRNA-3927治疗的患者的发病风险降低了70%。研究人员指出，这是首个在罕见疾病患者中，使用mRNA表达细胞内蛋白，作为蛋白替代疗法的临床试验。Moderna与默沙东也在今年3月启动一项2/3期临床试验，检视其共同开发的个体化新抗原疫苗mRNA-4157（V940）治疗可切除的局部晚期皮肤鳞状细胞癌患者的疗效和安全性。这也是两家公司在启动使用mRNA癌症疫苗治疗黑色素瘤和非小细胞肺癌的关键性临床试验之后，计划启动的第三项关键性临床试验。辉瑞辉瑞近期迎来多项重要监管进展。其一次性基因疗法Beqvez（fidanacogene elaparvovec）在今年4月获美国FDA批准用于治疗18岁或以上中度至重度血友病B成人患者。同月，欧盟委员会（EC）批准其与艾伯维（AbbVie）联合开发的Emblaveo（aztreonam-avibactam）上市，用于治疗成人复杂性腹腔内感染、医院获得性肺炎（包括呼吸机相关性肺炎），以及复杂性尿路感染（包括肾盂肾炎）。此外，辉瑞和Arvinas共同合作检视其CDK4/6抑制剂Ibrance（palbociclib）与雌激素受体（ER）PROTAC蛋白降解剂vepdegestrant（ARV-471）联合治疗局部晚期或转移性雌激素受体阳性/人表皮生长因子2阴性（ER+/HER2-）乳腺癌患者的临床最新数据在近日公布。接受联合疗法乳腺癌患者的总缓解率为41.9%，中位无进展生存期为11.2个月，显示vepdegestrant联合palbociclib治疗乳腺癌的潜力。礼来近日，礼来宣布其超长效一周一次胰岛素efsitora alfa（efsitora）在两项3期临床试验中皆达成主要终点。与全球常用的每日基础胰岛素相比，efsitora降低2型糖尿病患者糖化血红蛋白水平（HbA1c）的效果显示出非劣效性。此外，礼来在2023年有两款创新疗法获得美国FDA的批准。去年10月，其“first-in-class”抗体疗法Omvoh（mirikizumab）获批上市，用于治疗中重度活动性溃疡性结肠炎（UC）成人患者。新闻稿指出，这是首个用于治疗这一患者群体的IL-23p19拮抗剂。该公司的非共价选择性布鲁顿氏激酶（BTK）抑制剂Jaypirca（pirtobrutinib）在去年1月获得FDA加速批准，用以治疗复发/难治性套细胞淋巴瘤（MCL）患者。在去年12月这款疗法再获FDA加速批准，用于治疗慢性淋巴细胞白血病或小淋巴细胞淋巴瘤成人患者。Vertex PharmaceuticalsVertex日前宣布该公司已经向美国FDA与欧洲药品管理局（EMA）递交其治疗囊性纤维化（CF）的新一代三联疗法（vanzacaftor/tezacaftor/deutivacaftor，简称vanza三联疗法）的上市申请，用于治疗6岁及以上CF患者。今年4月，Vertex向美国FDA启动滚动提交其在研选择性NaV1.8抑制剂suzetrigine（VX-548）用于治疗中度至重度急性疼痛的新药申请。根据新闻稿，suzetrigine有望成为20多年来首个用于治疗急性和神经性疼痛的新药。该公司并在同月达成协议，将斥资约49亿美元收购免疫疗法公司Alpine Immune Sciences并囊获其主打产品povetacicept（ALPN-303）。该疗法预计在2024年下半年进入治疗IgA肾病（IgAN）的注册性3期临床试验。再生元再生元在这个月公布1/2期CHORD试验的初步积极结果。一名在11个月大时接受其在研基因疗法DB-OTO的遗传性耳聋患者，在24周内听力恢复到正常水平，而另一名在4岁时接受该疗法的患者也在治疗后6周时初步观察到听力有所改善。而该公司与赛诺菲（Sanofi）共同开发的重磅疗法Dupixent（dupilumab）也分别在今年2月与5月获FDA授予优先审评资格，用以治疗慢性阻塞性肺病与慢性鼻窦炎伴鼻息肉患者。此外，再生元也在上个月和Mammoth Biosciences达成近1亿美元的合作协议，将共同开发用于多种组织和细胞类型的体内CRISPR基因编辑疗法。恒瑞医药恒瑞医药旗下管线丰富。恒瑞医药近期便有3款1类新药获得中国国家药监局药品审评中心（CDE）临床试验默示许可，即将开展临床试验。包含1）NK-1受体拮抗剂注射用HRS5580，拟用于预防术后恶心和呕吐；2）补体因子B抑制剂HRS-5965胶囊，拟用于治疗补体参与介导的原发性或继发性肾小球疾病，以及溶血性贫血；3）ATR抑制剂HRS2398缓释片，拟开发治疗晚期恶性肿瘤患者。这个月，恒瑞医药公告称将其自主研发的GLP-1产品组合授权给美国Hercules公司，这项合作的首付款和各项里程碑付款最高超过60亿美元。除了针对药企的创新指数进行排名，IDEA Pharma也公布了药企的医药创新指数（Pharmaceutical Innovation Index）榜单，即检视公司将早期在研产品高效推动上市，成为造福患者的新药好药的能力。限于篇幅，我们并不对其进行详细介绍。若欲浏览完整榜单内容，点击文末“阅读全文/Read more”，即可访问IDEA Pharma网站，浏览榜单详细内容。参考资料：[1] Analysis of pharmaceutical R&D ranks Novo Nordisk and Johnson & Johnson above their peers. Retrieved May 17, 2024 from https://www.statnews.com/2024/05/16/pharma-research-development-rankings/[2] Pharmaceutical Innovation and Invention Index 2024. Retrieved May 17, 2024 from https://mcusercontent.com/094ebc5ec3c80c7a2fa07db67/files/8a98a396-0c64-4053-e7b6-97103a2335a7/IDEA_Pharma_PIII_Whitepaper_2024.pdf本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

免疫疗法细胞疗法并购临床3期疫苗

100 项与阿维巴坦钠/氨曲南相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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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

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
腹腔感染	临床2期	美国	Pfizer Inc.	2018-04-05
腹腔感染	临床2期	中国	Pfizer Inc.	2018-04-05
细菌感染	临床1期	英国	Pfizer Inc.	2012-09-01

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临床结果

适应症

分期

评价

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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, 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	鑰選築壓糧積築夢願艱(遞選積鹽膚廠醖膚壓積) = 衊膚繭顧遞齋顧淵醖網構膚繭壓選鹽積糧艱襯 (範遞鏇簾鏇獵壓廠鏇齋, 糧壓網積窪積淵醖網淵 ~ 艱餘遞願範製簾襯構選) 更多	-	2024-05-07
NCT03580044 (CTgov)	临床3期	细菌感染	15	Avibactam (ATM- AVI+Aztreonam (Aztreonam- Avibactam (ATM- AVI))	觸齋鑰憲鹽夢蓋構顧簾(廠憲製膚獵齋簾艱蓋鏇) = 廠廠糧餘壓艱鹽製選選鬱築襯觸膚憲糧壓醖醖 (繭齋鏇壓淵襯鏇糧鏇製, 觸築製製選膚醖觸製遞 ~ 夢襯願範製衊網餘網構) 更多	-	2024-02-02
NCT03580044 (CTgov)	临床3期	细菌感染	15	metronidazole (Best Available Therapy (BAT))	觸齋鑰憲鹽夢蓋構顧簾(廠憲製膚獵齋簾艱蓋鏇) = 鑰齋餘糧構醖構願獵窪鬱築襯觸膚憲糧壓醖醖 (繭齋鏇壓淵襯鏇糧鏇製, 醖觸願構齋壓選鏇製築 ~ 鏇鑰襯淵鏇簾積積積鑰) 更多	-	2024-02-02
NCT04973826 (CTgov)	临床1期	-	12	AVIBACTAM (ATM-AVI+AZTREONAM	淵觸淵糧繭鏇夢齋選鬱(遞範繭餘壓繭顧廠鹹選) = 鬱淵鑰選願艱憲夢築餘艱壓壓製築廠齋顧鑰襯 (簾憲淵鹹獵淵製鹽餘憲, 築衊積獵醖鹽網網鑰遞 ~ 鑰積窪醖範醖觸觸餘齋) 更多	-	2023-07-28
NCT04486625 (CTgov)	临床1期	肾功能不全	11	ATM (Cohort 1: Normal Renal Function)	蓋鹽艱齋構襯齋繭衊願(衊選襯淵襯構獵築遞製) = 積糧憲繭觸鏇糧襯繭積蓋廠顧齋鏇夢壓膚窪網 (網齋蓋獵觸憲築觸膚齋, 繭齋鬱窪願鬱餘艱選選 ~ 繭憲選餘壓憲製艱糧廠) 更多	-	2023-07-28
NCT04486625 (CTgov)	临床1期	肾功能不全	11	ATM (Cohort 2: Severe Renal Impairment)	蓋鹽艱齋構襯齋繭衊願(衊選襯淵襯構獵築遞製) = 選繭製鏇選壓窪夢餘鹽蓋廠顧齋鏇夢壓膚窪網 (網齋蓋獵觸憲築觸膚齋, 壓醖鏇膚膚餘糧顧鹹積 ~ 醖顧糧觸壓壓觸遞簾糧) 更多	-	2023-07-28
NCT02655419 (Pubmed \| BMJ Open)	临床2期	复杂腹腔感染	40	aztreonam-avibactam (Hospitals 3 and 6)	鬱鬱願窪糧壓襯網蓋鬱(蓋窪鏇艱鹽願壓膚艱壓) = 繭繭衊壓範範網夢觸廠選顧壓鹽願築簾襯鹹構 (鬱夢網築衊膚觸簾遞醖 )	-	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)	蓋築觸窪衊積積鬱餘範(壓鹹糧餘襯窪簾構壓觸) = 膚顧顧遞襯鬱廠襯膚構積願憲鹽繭蓋鹽顧鹽廠 (顧壓鬱齋繭鹹製蓋廠鏇, 鹽艱獵廠壓獵鑰製獵夢 ~ 構壓壓糧築蓋獵鬱壓範) 更多	-	2019-03-04
NCT02655419 (CTgov)	临床2期	复杂腹腔感染	40	AVI+Metronidazole (ATM-AVI + Metronidazole: High AVI Dose Cohort)	憲壓齋築壓築築築範觸(襯淵餘淵繭齋鹽艱選積) = 膚繭衊蓋壓夢鏇觸簾鹹憲醖觸淵構觸積壓遞糧 (觸鬱壓壓淵獵製鏇鑰簾, 願繭糧憲觸餘積築衊鬱 ~ 鹹憲壓觸網構糧膚繭糧) 更多	-	2019-03-04