A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

开始日期2023-08-06

申办/合作机构

Basilea Pharmaceutica AG

NCT04171674 / Unknown statusN/AIIT

A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia

The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.

开始日期2021-09-01

申办/合作机构

Centre Hospitalier Universitaire de Bordeaux

NCT04170309 / CompletedN/A

Retrospective Chart Review to Evaluate the Safety Profile of Ceftobiprole in Patients With Impaired Hepatic or Renal Function or Immunosuppression

In this observational study, data from patients treated with the antibiotic ceftobiprole in the past will be collected. The sponsor of the study is Correvio International Sárl, based in Switzerland. Correvio has committed to the health authorities to obtain further information on possible side effects especially in patients suffering from impaired liver or renal function or immune system deficiency and compare these effects to the ones observed in patients without these health problems. Patient data are collected from historic patient charts, patients will not be treated for the purpose of this data collection. All efforts are being made to capture the data of all patients who meet the inclusion criteria and have received at least one dose of ceftobiprole since this drug was first prescribed at the site.

开始日期2020-03-30

申办/合作机构

Advanz Pharma Corp. Ltd.

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100 项与头孢比罗酯钠相关的临床结果

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100 项与头孢比罗酯钠相关的转化医学

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100 项与头孢比罗酯钠相关的专利（医药）

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412

项与头孢比罗酯钠相关的文献（医药）

2024-10-01·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Comparative in vitro efficacy of antibiotics against the intracellular reservoir of Staphylococcus aureus

Article

作者: Yamauchi, Joe ; Wong-Beringer, Annie ; Beadell, Brent

Abstract:

Staphylococcus aureus (SA) is a leading cause of bloodstream infection. The liver represents the sentinel immune organ for clearance of bloodstream pathogens and eradication of intracellular SA from liver-resident macrophages (Kupffer cells, KCs) eliminates the likely pathogenic reservoir that contributes to persistent bacteraemia.

Objectives:

We assessed antimicrobial activity at phagolysosome-mimicking pH, intracellular penetration, and SA eradication within KCs in vitro for clinically prescribed antistaphylococcal agents alone or in combination: vancomycin, daptomycin, ceftaroline, ceftobiprole, oritavancin, oxacillin, cefazolin; rifampin and fosfomycin.

Methods:

pH-adjusted broth microdilution assays, intracellular bioaccumulation assays, and intracellular killing assays against clinical bloodstream isolates were performed using a murine KC line with study agents.

Results:

Rifampin and β-lactams exhibited enhanced activity [2- to 16-fold minimum inhibitory concentrations (MIC) decrease] at phagolysosomal pH while vancomycin, oritavancin, daptomycin and fosfomycin demonstrated reduced activity (2- to 32-fold MIC increase in order of least to greatest potency reduction). All agents evaluated had poor to modest intracellular to extracellular concentration ratios (0.024–7.8), with exceptions of rifampin and oritavancin (intracellular to extracellular ratios of 17.4 and 78.2, respectively). Finally, we showed that the first-line treatment for SA bacteraemia (SAB), vancomycin, performed worse than all other tested antibiotics in eradicating intracellular SA at human Cmax concentration (0.20 log cfu decrease), while oritavancin performed better than all other agents alone (2.05 versus 1.06–1.36 log cfu decrease).

Conclusions:

Our findings raise concerns about the efficacy of commonly prescribed antibiotics against intracellular SA reservoirs and emphasize the need to consider targeting pathogen eradication from the liver to achieve early control of SAB.

2024-09-27·CURRENT DRUG METABOLISM

Ceftobiprole and Cefiderocol for Patients on Extracorporeal Membrane Oxygenation: The Role of Therapeutic Drug Monitoring

Article

作者: Granton, John ; Fan, Eddy ; Castro, Diana Morales

Introduction::

Limited data exist on therapeutic ranges for newer antimicrobials in the critically ill, with few pharmacokinetic studies including patients undergoing renal replacement therapy or extracorporeal membrane oxygenation (ECMO).

Case Representation::

These interventions can potentially alter the pharmacokinetic profile of antibiotics, resulting in therapeutic failures, antimicrobial resistance, or increased toxicity. In this report, we present two ECMO patients treated with cefiderocol and ceftobiprole, where therapeutic drug monitoring (TDM) aided in the successful treatment of severe infections. Antibiotic trough concentrations in both cases were consistent with previously reported therapeutic levels in critically ill and ECMO patients, meeting minimal inhibitory concentrations recommended by the European Committee on Antimicrobial Susceptibility Testing for the respective pathogens.

Conclusion::

Treatment might be suboptimal if doses are not adjusted based on physicochemical properties and extracorporeal support. In an era marked by highly resistant pathogens, these cases highlight the importance of timely access to real-time TDM for optimizing and individualizing antimicrobial treatment.

2024-08-17·Journal of chemotherapy (Florence, Italy)

Evaluation of in vitro activity of ceftaroline, ceftobiprole and their combination with trimethoprim/sulfamethoxazole against MRSA isolates: a two center study

Article

作者: Öğüç Şanlı, Özlem ; Mirza, Hasan Cenk

There is an increasing need for new synergistic antimicrobial combinations against multidrug-resistant bacteria. Our objective was to evaluate the activity of ceftaroline, ceftobiprole and their combination with trimethoprim/sulfamethoxazole against methicillin-resistant Staphylococcus aureus (MRSA) isolates recovered at two centers in Turkey. Activities of ceftaroline and ceftobiprole were tested against 100 MRSA isolates using gradient diffusion method. Activities of ceftaroline and ceftobiprole in combination with trimethoprim/sulfamethoxazole against 20 selected isolates (including all isolates that were non-susceptible to ceftaroline or ceftobiprole, and randomly selected isolates) were investigated using MIC:MIC ratio method. Antimicrobial interactions were interpreted using the fractional inhibitory concentration (FIC) index. The MIC₅₀/MIC₉₀ values for ceftaroline and ceftobiprole were 0.75/1 and 1/1.5 mg/L, respectively. Ceftaroline and ceftobiprole susceptibility rates among 100 MRSA isolates were 94% and 96%, respectively. Ceftaroline, ceftobiprole and trimethoprim/sulfamethoxazole MICs of isolates were not increased when ceftaroline or ceftobiprole was combined with trimethoprim/sulfamethoxazole. Ceftobiprole- trimethoprim/sulfamethoxazole combination demonstrated additivity against 35%, whereas ceftaroline- trimethoprim/sulfamethoxazole combination demonstrated additivity against 10% of 20 MRSA isolates. The remaining interactions for MRSA isolates were indifference. Three (75%) of four ceftobiprole-resistant isolates became susceptible to ceftobiprole after adding trimethoprim/sulfamethoxazole. None of the ceftaroline non-susceptible isolates became susceptible to ceftaroline after adding trimethoprim/sulfamethoxazole. Ceftobiprole- trimethoprim/sulfamethoxazole combination may be a better treatment option than ceftaroline- trimethoprim/sulfamethoxazole combination for MRSA infections. Clinical studies are needed to confirm the results of our in vitro study.

107

项与头孢比罗酯钠相关的新闻（医药）

2024-10-11

·药精通Bio

2024 FDA已批准34款新药！其中Q3新增13款！

OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769 🧴Berdazimer （Zelsuvmi），一种用于治疗局部传染性软疣的一氧化氮（NO）释放剂。💉头孢吡肟/恩美唑巴坦（Exblifep），一种包含头孢吡肟和恩美唑巴坦的固定剂量组合，用于治疗尿路感染。 💉LetibotulinumtoxinA （Letybo），一种纯化的 A 型肉毒杆菌神经毒素蛋白复合物，用于改善眉间纹的外观。💉替雷利珠单抗（Tivembra）是一种 IgG4 变体 PD-1 mAb，适用于治疗不可切除、局部晚期或转移性食管鳞状细胞癌。💊Resmetirom （Rezdiffra），一种甲状腺激素受体 β （NR1A2）激动剂用于治疗非肝硬化性非酒精性脂肪性肝炎。 💊Aprocitentan （Tryvio），一种用于治疗高血压的内皮素受体拮抗剂。💊Givinostat （Duvyzat），一种组蛋白脱乙酰酶抑制剂，用于治疗杜氏肌营养不良症。💉 Sotatercept （Winrevair），一种用于治疗肺动脉高压的激活素信号抑制剂。💊 Vadadustat （Vafseo），一种口服缺氧诱导因子脯氨酰羟化酶抑制剂，用于治疗成人与 CKD 相关的症状性贫血。💊 Danicopan （Voydeya），补体因子 D 抑制剂，用于治疗 PNH 患者的血管外溶血。 💉 Ceftobiprole medocaril （Zevtera）是一种广谱头孢菌素抗菌剂，适用于某些类型的肺炎、菌血症和皮肤感染。💉 Pegulicianine （Lumisight），一种用于乳腺癌荧光成像的光学成像剂。💉 Nogapendekin alfa inbakicept （Anktiva）是一种白细胞介素 15 受体激动剂与卡介苗（BCG）的组合，用于治疗膀胱癌。 💊 Tovorafenib （Ojemda），一种 II 型 RAF 激酶抑制剂，用于治疗具有 BRAF 基因突变的小儿低级别胶质瘤。💊 Mavorixafor （Xolremdi），一种用于治疗 WHIM 综合征的 CXCR4 拮抗剂。💉 Tarlatamab （Imdelltra）是一种靶向 DLL3 和 CD3 的双特异性单克隆抗体和 T 细胞接合器，用于治疗广泛期小细胞肺癌。💉 Imetelstat （Rytelo），一种寡核苷酸端粒酶抑制剂，用于治疗骨髓增生异常综合征伴输血依赖性贫血。 💊 Elafibranor （Iqirvo），一种双重 PPARα/δ 激动剂，用于治疗原发性胆汁性胆管炎。🧴Sofpironium （Sofdra），一种用于治疗多汗症的 M3 毒蕈碱受体抑制剂。💉 Crovalimab （Piasky），一种用于治疗阵发性睡眠性血红蛋白尿症的补体 C5 抑制性 mAb。🫁 Ensifentrine，一种用于治疗 COPD 的双重 PDE3/4 抑制剂。💉Donanemab-azbt，一样β淀粉样蛋白（Aβ）定向抗体，用于治疗阿尔兹海默病。💊Deuruxolitinib，一种JAK1和JAK2抑制剂，用于治疗严重斑秃。💊Vorasidenib，一种 IDH1 和 IDH2 抑制剂，用于治疗具有易感 IDH1 或 IDH2 突变的 2 级星形细胞瘤或少突胶质细胞瘤。💉Palopegteriparatide，一种用于治疗甲状旁腺功能亢进症的甲状旁腺激素类似物。💉Nemolizumab，一种用于治疗结节性痒疹的 IL-31 受体 α 拮抗剂。 💊Seladelpar 是一种 PPAR-δ 激动剂，用于单独治疗原发性胆汁性胆管炎或与熊去氧胆酸联合治疗。💉Axatilimab 是一种 CSF-1R mAb，用于降低慢性移植物抗宿主病患者的致病性巨噬细胞活性。💊Lazertinib，一种 EGFRm 激酶抑制剂，与 amivantamab 联合用于治疗具有 EGFR 突变的非小细胞肺癌。💉Lebrikizumab，一种抗 IL-13 的 IgG4 mAb，用于治疗中度至重度特应性皮炎。💊Arimoclomol 是一种热休克蛋白共诱导剂，用于与 miglustat 联合治疗 C 型尼曼-匹克病的神经系统症状。💊L-乙酰亮氨酸，亮氨酸的一种改良形式，用于治疗 C 型尼曼-匹克病患者的神经系统症状。💊Xanomeline 和 trospium chloride，联合双重 M 1 - 和 M 4 - 选择性毒蕈碱受体激动剂和毒蕈碱受体拮抗剂，用于治疗精神分裂症。 💉Flurpiridaz F-18，一种用于评估心肌缺血和梗死的放射性诊断药物Picture from Chris De Savi 文章来源：早研早聊参考素材：素材来源官方媒体/网络新闻 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

上市批准

2024-10-10

·BiG生物创新社

2024年FDA批准新药汇总

作者｜momo 截止目前，FDA已经批准35款新药上市，其中多款药物具有里程碑意义。 01 2024年FDA已批准药物 1.1.Zelsuvmi (berdazimer) 适应症：局部传染性软疣批准日期：2024年1月5日企业：Novan Inc. 1.2.Exblifep (cefepime and enmetazobactam) 适应症：尿路感染靶点：LACTB、PBP 批准日期：2024年2月22日企业：Orchid Chemicals & Pharmaceuticals Ltd. 1.3.Letybo (letibotulinumtoxin a-WLBG) 适应症：中度至重度眉间纹的外观改善靶点：BoNT/A 批准日期：2024年2月29日企业：Hugel Inc. 1.4.Tevimbra (tislelizumab-JSGR) 适应症：不可切除、局部晚期或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年3月13日企业：百济神州 1.5.Rezdiffra (resmetirom) 适应症：中晚期非肝硬化性非酒精性脂肪性肝炎靶点：THR-β 批准日期：2024年3月14日企业：罗氏 1.6.Tryvio 适应症：高血压靶点：ET-A、ET-B 批准日期：2024年3月19日企业：Idorsia. 1.7.Duvyzat 适应症：杜氏肌营养不良症靶点：HDAC 批准日期：2024年3月21日企业：Italfarmaco Spa. 1.8.Winrevair (sotatercept-CSRK) 适应症：肺动脉高压靶点：INHBA 批准日期：2024年3月26日企业：Acceleron Pharma Inc. 1.9.Vafseo 适应症：成人慢性肾脏疾病引起的贫血靶点：HIF 批准日期：2024年3月27日企业：宝洁 1.10.Voydeya 适应症：阵发性夜间血红蛋白尿治疗血管外溶血靶点：CFD 批准日期：2024年3月29日企业：Achillion Pharmaceuticals Inc. 1.11.Zevtera (ceftobiprole medocaril sodium) 适应症：血液感染、细菌性皮肤和相关组织感染、社区获得性细菌性肺炎靶点：PBP 批准日期：2024年4月3日企业：Roche 1.12.Lumisight 适应症：乳腺癌荧光成像批准日期：2024年4月17日企业：Lumicell Inc., 杜克大学 1.13.Anktiva (nogapendekin alfa inbakicept-pmln) 适应症：膀胱癌靶点：IL-15R 批准日期：2024年4月22日企业：Altor Bioscience Corp. 1.14.Ojemda (tovorafenib) 适应症：复发或难治性儿童低级别胶质瘤靶点:RAF 批准日期：2024年4月23日企业：Viracta Therapeutics Inc. 1.15.Xolremdi (mavorixafor) 适应症：治疗12岁及以上患有WHIM综合征的患者靶点：CXCR4 批准日期：2024年4月26日企业：赛诺菲 1.16.Imdelltra (tarlatamab-dlle) 适应症：广泛期小细胞肺癌靶点：CD3E、DLL3 批准日期：2024年5月16日企业：Amgen Inc. 1.17.Rytelo (imetelstat) 适应症：低危骨髓增生异常综合征伴输血依赖性贫血靶点：Telomerase 批准日期：2024年6月6日企业：Geron Corp. 1.18.Iqirvo (elafibranor) 适应症：原发性胆汁性胆管炎靶点：PPARɑ/γ 批准日期：2024年6月10日企业：Genfit SA 1.19.Sofdra (sofpironium) 适应症：原发性腋窝多汗症靶点：AChR 批准日期：2024年6月18日企业：Bodor Laboratories Inc. 1.20.Piasky (crovalimab-akkz) 适应症：阵发性睡眠性血红蛋白尿症靶点：C5 批准日期：2024年6月20日企业：Sino-Foreign Pharmaceutical Co., Ltd. 1.21.Ohtuvayre（Ensifentrine）适应症：治疗慢性阻塞性肺病靶点：PDE3/4 批准日期：2024年6月26日企业：Verona Pharma. 1.22.Kisunla（Donanemab-azbt）适应症：阿尔兹海默病靶点：pGlu3Aβ 批准日期：2024年7月2日企业：lilly 1.23.Leqselvi（Deuruxolitinib）适应症：严重斑秃靶点：JAK 批准日期：2024年7月25日企业：Sun Pharmaceuticals 1.24.Voranigo（vorasidenib）适应症：IDH1或IDH2易感突变的2级星形细胞瘤或少突胶质细胞瘤。靶点：IDH1、IDH2 批准日期：2024年8月6日企业：Servier Pharmaceuticals 1.25.Yorvipath（palopegteriparatide）适应症：甲状旁腺功能亢进批准日期：2024年8月9日企业：ascendis Pharma. 1.26.Nemluvio（nemolizumab-ilto）适应症：结节性痒疹靶点:IL-31 批准日期：2024年8月12日企业：Galderma Pharma. 1.27. Livdelzi（seladelpar）适应症：原发性胆汁性胆管炎靶点：PPAR-δ 批准日期：2024年8月14日企业：Gilead Sciences 1.28.Niktimvo（axatilimab-csfr）适应症：慢性移植物抗宿主病靶点CSF-1R 批准日期：2024年8月14日企业：Incyte/Syndax制药 1.29.Lazcluze（lazertinib）适应症：非小细胞肺癌靶点：EGFRm 批准日期：2024年8月19日企业：强生 1.30.Ebglyss（lebrikizumab-lbkz）适应症：中度至重度特应性皮炎靶点：IL-13 批准日期：2024年9月13日企业：lilly 1.31.Miplyffa（arimoclomol）适应症：C型尼曼-匹克病靶点：HSP 批准日期：2024年9月20日企业：Zevra Therapeutics 1.32.Aqneursa （levacetylleucine）适应症：儿童和成人C型尼曼匹克病批准日期：2024年9月24日企业：IntraBio. 1.33.Cobenfy（xanomeline and trospium chloride）适应症：成人精神分裂症靶点：M1-和M4-选择性毒蕈碱受体批准日期：2024年9月26日企业：百时美施贵宝 1.34.Flyrcado（flurpiridaz F 18）适应症：评估心脏血流阻塞（心肌缺血）和心脏病发作（心肌梗塞）批准日期：2024年9月27日企业：GE HealthCare 1.35.Tevimbra（Tislelizumab）适应症：不可切除或转移性食管鳞状细胞癌靶点：PD-1 批准日期：2024年10月4日企业：百济神州 02 2024年FDA批准的突出药物 Voranigo（vorasidenib）这种双重IDH1/IDH2抑制剂处理导致癌细胞代谢变化的突变。它被批准用于2级星形细胞瘤或少突胶质细胞瘤，这是一种生长缓慢的脑肿瘤，具有显著的风险。这是一个突破，因为它直接针对驱动肿瘤生长的突变，提供了一种更有效的治疗选择，可以延缓疾病进展，减少对辐射等侵入性治疗的依赖。 Niktimvo（Axatilimab）是一种CSF-1R单克隆抗体，通过限制巨噬细胞活性来治疗cGVHD，巨噬细胞在免疫应答中起着至关重要的作用。这种疗法对患有cGVHD的患者至关重要，这是干细胞移植后的一种严重并发症，通常对现有治疗无效。它提供了一种更有针对性的策略来改善患者的生活质量。 Cobenfy作为Xanomeline和Trospium Chloride这种联合治疗方法，通过调节毒蕈碱受体，为治疗精神分裂症带来了新的途径。通过平衡大脑中的神经递质活动，它解决了这种疾病的阳性和阴性症状，这使得它对那些用其他药物都没有成功的患者特别有价值。它的双重机制提供了更全面的症状管理，改善了那些受这种具有挑战性的精神健康状况影响的结果。 Rezdiffra（resmetirom）是一款甲状腺激素受体（THR）-β口服选择性激动剂，THR-β在肝脏中高度表达，能够调节脂代谢，降低LDL-C、甘油三酯和致动脉粥样硬化性脂蛋白。此外，THR-β还能通过促进脂肪酸的分解和刺激线粒体的生物发生来减少脂肪毒性并改善肝功能，从而减少肝脏脂肪。Rezdiffra用于治疗患有中重度肝纤维化（F2至F3期）的非肝硬化非酒精性脂肪性肝炎（NASH）患者，成为FDA批准的首款NASH疗法，具有里程碑意义。 Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。它与βγ T细胞受体结合，直接特异性刺激CD8阳性T细胞和NK细胞，同时避免刺激调节性T细胞（Treg）。与天然、非复合IL-15相比，Anktiva在患者体内具有更优的药代动力学特性，且能在淋巴组织中存在更长时间，表现出增强的抗肿瘤活性。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。参考资料 [1]Novel Drug Approvals for 2024 | FDA [2]百济神州官网 BiG近期会议 10月26日，第三届生物计算大会保留栏目-第二届吐槽大会即将再度来袭！本届吐槽大会将围绕投融资、行业心态、年轻人，及AI等热门话题展开策划，通过移幕换景，大咖带新秀，让更多80-00后的行业亲历者来到聚光灯下，邀与会嘉宾一同探讨AI+Biomed的融合之道！共建Biomedical创新生态圈！如何加入BiG会员？

上市批准

2024-09-24

·GlobeNewswire-Health Care

Basilea initiates clinical phase 3 study with antifungal fosmanogepix in candidemia and invasive candidiasis

Allschwil, Switzerland, September 24, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has initiated the Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) phase 3 study. This registrational study evaluates the efficacy and safety of Basilea’s broad-spectrum antifungal fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, that is Candida yeast bloodstream or deep-seated tissue infections.1 Fosmanogepix is a first-in-class antifungal treatment candidate with a novel mechanism of action. It is available in intravenous and oral formulations and has been evaluated for efficacy and safety in a phase 1 / phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections.2, 3, 4, 5 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased to have activated the first study center in the phase 3 program for fosmanogepix and look forward to enrolling patients into FAST-IC. Invasive Candida infections are life-threatening complications for many hospitalized patients and associated with high mortality, and fosmanogepix offers a potential new treatment option in this high medical need area. In addition, we are working towards starting the second phase 3 study investigating fosmanogepix in the treatment of adult patients with invasive mold infections around year-end.” FAST-IC is a global, multi-center, randomized, active-controlled, double-blind phase 3 study and investigates intravenous (i.v.) fosmanogepix versus a standard-of-care regimen of i.v. caspofungin in adult patients with candidemia and/or invasive candidiasis. The study is expected to enroll approximately 450 patients, who will be randomized in a 2:1 ratio to either fosmanogepix or caspofungin. There is an optional oral switch to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. The Swiss-based global company PSI CRO AG will manage the phase 3 program. Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc., in November 2023. Under the terms of the asset purchase agreement, Basilea assumed all rights and obligations from previous agreements, and will make a USD 6.0 million milestone payment under these obligations, upon the enrolment of the first patient, which is fully reflected in Basilea’s most recent financial guidance for the full year 2024. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.2 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris, and invasive mold infections.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.6, 7 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.8 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.9 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This press release can be downloaded from www.basilea.com. References ClinicalTrials.gov identifier: NCT05421858K. J. Shaw, A. S. Ibrahim. Fosmanogepix:A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480J. Cadena, G. R. Thompson 3rd, T. F..Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 23, 2024)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF).pdf

临床2期临床3期孤儿药快速通道临床结果

100 项与头孢比罗酯钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢比罗酯钠	J01DI01	DB14733

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
社区获得性细菌性肺炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
右侧感染性心内膜炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
皮肤和皮肤结构感染	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
金黄色葡萄球菌菌血症	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
社区获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20
医院获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20

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
传染性皮肤病	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
软组织感染	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
新生儿败血症	临床3期	美国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	保加利亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	爱沙尼亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	德国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	拉脱维亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	立陶宛	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	波兰	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	斯洛伐克	Basilea Pharmaceutica AG	2023-08-06

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临床结果

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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


NCT03137173 (FDA_CDER) 人工标引	临床3期	皮肤和皮肤结构感染	679	ZEVTERA 667 mg	顧製襯鑰鹽襯鹹顧顧網(衊鹽齋壓選蓋壓鑰齋積) = 壓餘糧廠鏇壓獵獵壓製餘鏇齋觸願醖選繭餘觸 (獵衊網鹹鑰積壓窪選選 ) 更多	积极	2024-04-03
				Vancomycin plus aztreonam	顧製襯鑰鹽襯鹹顧顧網(衊鹽齋壓選蓋壓鑰齋積) = 範窪範壓選顧膚選憲壓餘鏇齋觸願醖選繭餘觸 (獵衊網鹹鑰積壓窪選選 ) 更多
NCT00326287 \| NCT03439124 (FDA_CDER) 人工标引	临床3期	社区获得性细菌性肺炎	-	Ceftobiprole medocaril (Adult Patients)	鹹廠餘艱觸壓築觸遞壓(夢獵範鑰遞積繭襯範廠) = 積簾餘糧獵簾獵鑰壓築衊築鑰遞簾襯鏇鹹觸窪 (範構壓齋齋襯網糧餘鹹 ) 更多	积极	2024-04-03
				Ceftriaxone with or without Linezolid (Adult Patients)	鹹廠餘艱觸壓築觸遞壓(夢獵範鑰遞積繭襯範廠) = 鬱糧選顧襯壓構獵顧壓衊築鑰遞簾襯鏇鹹觸窪 (範構壓齋齋襯網糧餘鹹 ) 更多
NCT03138733 (FDA_CDER) 人工标引	临床3期	金黄色葡萄球菌菌血症	387	ZEVTERA	積鹹鬱觸範鑰範膚繭壓(廠觸糧築繭範顧窪選醖) = 繭鬱夢衊網夢鬱醖艱廠觸壓衊積築築衊糧廠餘 (鏇構選艱製糧膚願鑰夢 ) 更多	积极	2024-04-03
				Daptomycin	積鹹鬱觸範鑰範膚繭壓(廠觸糧築繭範顧窪選醖) = 淵遞積鏇艱淵淵觸壓壓觸壓衊積築築衊糧廠餘 (鏇構選艱製糧膚願鑰夢 ) 更多
NCT03138733 (ERADICATE, Pubmed)	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	齋糧構淵簾繭壓壓蓋範(膚艱廠構願製齋製製襯) = 網襯願鏇鹽鬱醖淵鏇淵餘壓鹽襯糧範範餘鬱淵 (膚簾網糧憲鹽願鏇繭衊 ) 更多	积极	2023-10-12
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	齋糧構淵簾繭壓壓蓋範(膚艱廠構願製齋製製襯) = 構簾醖願醖衊遞鏇願襯餘壓鹽襯糧範範餘鬱淵 (膚簾網糧憲鹽願鏇繭衊 ) 更多
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	临床3期	金黄色葡萄球菌菌血症	390	Daptomycin	積齋觸構積窪蓋憲壓窪(遞鏇襯淵鬱繭淵繭製觸) = 繭網願襯蓋夢鹽獵齋憲築範淵憲夢簾齋艱築壓 (製鹽齋顧壓鑰夢艱鹽鹹, 簾淵製選遞築廠憲製積 ~ 窪繭鹽糧鹹衊築壓網憲) 更多	-	2023-05-06
NCT03138733 (ERADICATE, Corporate Publications) 人工标引	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole Medocaril Sodium	鬱遞廠顧鹽網衊遞積鹽(願築繭遞選顧夢壓範襯) = 積積醖構餘糧衊構繭衊壓窪築獵鹽簾獵願築積 (觸廠選憲壓繭構獵淵齋 ) 更多	非劣	2022-10-24
				Aztreonam+Daptomycin	鬱遞廠顧鹽網衊遞積鹽(願築繭遞選顧夢壓範襯) = 顧願獵願艱窪鑰願膚膚壓窪築獵鹽簾獵願築積 (觸廠選憲壓繭構獵淵齋 ) 更多
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	N/A	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	襯窪壓壓願窪鏇構簾觸(觸夢構願醖衊壓膚廠築) = 遞觸憲選艱壓鏇願願淵襯蓋鬱淵醖鹹網鬱鑰廠 (餘願範簾齋簾範鑰鏇製 ) 更多	-	2021-11-01
				Ceftobiprole (Patients 3 months to 17 years of age)	襯窪壓壓願窪鏇構簾觸(觸夢構願醖衊壓膚廠築) = 築糧網糧餘衊廠廠選積襯蓋鬱淵醖鹹網鬱鑰廠 (餘願範簾齋簾範鑰鏇製 ) 更多
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) 人工标引	临床3期	皮肤和皮肤结构感染	679	Ceftobiprole Medocaril Sodium	餘鬱夢鏇蓋醖顧蓋鏇膚(窪壓製膚窪艱廠鹹衊糧) = 醖糧壓醖築壓網蓋遞鬱艱衊遞鑰窪淵願遞觸壓 (夢範淵膚齋醖壓廠築網 ) 更多	非劣	2021-10-05
				Vancomycin Hydrochloride+Aztreonam	餘鬱夢鏇蓋醖顧蓋鏇膚(窪壓製膚窪艱廠鹹衊糧) = 製醖糧獵壓積觸窪構襯艱衊遞鑰窪淵願遞觸壓 (夢範淵膚齋醖壓廠築網 ) 更多
NCT02527681 (CTgov)	临床1期	细菌感染	15	Ceftobiprole (Ceftobiprole PK Population)	繭糧網餘醖選蓋衊願壓(製構製窪鹹襯窪淵鏇構) = 選憲簾餘鏇鹹憲艱夢廠窪觸遞艱遞壓鏇構膚顧 (膚襯憲製鑰襯窪糧遞夢, 憲夢網艱蓋憲製網憲積 ~ 構窪範壓積網鹽廠觸鹽) 更多	-	2021-01-06
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	鏇顧廠觸鏇襯鑰範襯鏇(襯餘鬱築觸觸膚鬱遞網) = 選襯壓鬱蓋鬱衊鑰鏇鹹鏇鏇範艱網遞衊願鹽鹽 (積選範製鬱觸齋夢廠願, 積壓膚糧製蓋壓築製壓 ~ 繭壓蓋艱繭製餘鏇簾鬱) 更多
NCT03439124 (Trial 5, CTgov)	临床3期	社区获得性肺炎 \| 医院获得性肺炎	138	ceftobiprole medocaril (Ceftobiprole Medocaril)	網壓淵廠鑰繭壓醖鹹淵(衊鑰衊積衊膚構獵窪齋) = 遞膚範蓋憲憲範築壓憲願醖蓋網構壓觸製艱淵 (簾糧憲蓋壓糧網遞餘網, 遞鬱顧醖淵襯鬱糧選製 ~ 壓鏇艱願願範顧鬱鬱鬱) 更多	-	2020-09-11
				IV standard-of-care cephalosporin (IV Standard-of-care Cephalosporin)	網壓淵廠鑰繭壓醖鹹淵(衊鑰衊積衊膚構獵窪齋) = 窪積遞顧獵廠壓艱餘鑰願醖蓋網構壓觸製艱淵 (簾糧憲蓋壓糧網遞餘網, 糧鏇鑰齋範衊觸膚構獵 ~ 艱鹹憲衊鹹構餘廠膚壓) 更多