Rivabazumab pegol(Rivabazumab pegol) - 药物靶点：T3SS_专利_临床

概要

基本信息

药物类型

Fab片段抗体

别名

Anti-PcrV mAb fragment

靶点

T3SS

作用机制

T3SS抑制剂(III型分泌系统蛋白抑制剂)

治疗领域

感染遗传病与畸形消化系统疾病+ [2]

在研适应症-

非在研适应症

囊性纤维化呼吸机相关性肺炎铜绿假单胞菌感染+ [1]

原研机构

Humanigen, Inc.

在研机构-

非在研机构

Humanigen, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 319922166L

来源: *****

Sequence Code 319922165H

来源: *****

关联

5

项与 Rivabazumab pegol 相关的临床试验

JPRN-UMIN000038909 / CompletedIIT

Effect of hair growth KB001 - Effect of hair growth KB001

开始日期2019-11-01

申办/合作机构-

NCT01695343 / Completed临床2期

A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa

The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.

开始日期2012-12-01

申办/合作机构

Humanigen, Inc.

NCT00691587 / Completed临床1/2期

A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

开始日期2008-04-01

申办/合作机构

Humanigen, Inc.

100 项与 Rivabazumab pegol 相关的临床结果

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100 项与 Rivabazumab pegol 相关的转化医学

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100 项与 Rivabazumab pegol 相关的专利（医药）

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7

项与 Rivabazumab pegol 相关的文献（医药）

2022-12-01·Saudi Pharmaceutical Journal

Molecular targets for cystic fibrosis and therapeutic potential of monoclonal antibodies

Review

作者: Al Basheer, Asmaa ; Moni, Sivakumar S

Cystic fibrosis (CF) is a genetic disease that affects the exocrine glands and is caused by cystic fibrosis transmembrane conductance regulator gene (CFTR) mutations. Lung disease is the leading cause of morbidity in patients. Target-specific treatment of CF has been achieved using monoclonal antibodies (mAbs). The purpose of this article is to discuss the possibility of treating CF with mAbs through their significant target specificity. We searched electronic databases in Web of Science, PubMed, EMBASE, Scopus, and Google Scholar from 1984 to 2021. We discussed the critical role of targeted therapy in cystic fibrosis, as it will be more effective at suppressing the molecular networks. After conducting a critical review of the available literature, we concluded that it is critical to understand the fundamental molecular mechanisms underlying CF prior to incorporating biologics into the therapy regimen. Omalizumab, Mepolizumab, Benralizumab, Dupilumab and KB001-A have been successfully screened for asthma-complicated CF, and their efficacies have been well reported. Despite the availability of effective targeted biologics, treating CF has remained a difficult task, particularly when it comes to reduction of secondary inflammatory mediators. This review emphasizes the overall views on CF, the immunological mechanism of CF, and the prospective therapeutic use of mAbs as potential targeted biologics for enhancing the overall status of human health.

2018-07-01·Journal of Cystic Fibrosis2区 · 医学

KB001-A, a novel anti-inflammatory, found to be safe and well-tolerated in cystic fibrosis patients infected with Pseudomonas aeruginosa

2区 · 医学

Article

作者: Beckett, V V ; Milla, Carlos ; Mayer-Hamblett, N ; VanDevanter, D R ; Burns, J L ; Accurso, F J ; Konstan, M W ; Chmiel, J F ; Jain, Raksha

BACKGROUNDChronic Pseudomonas aeruginosa (Pa) airways infection, exuberant local inflammation, and progressive lung function loss are hallmarks of cystic fibrosis (CF). KB001-A is an anti-PcrV PEGylated monoclonal antibody fragment to the Type III secretion system of Pa. This 16-week study evaluated KB001-A associated effect on time-to-need for antibiotics for worsening respiratory signs and symptoms, as well as safety, and treatment-associated changes in symptom scores, inflammatory markers, and spirometry.METHODSThis was a randomized, double-blind, placebo-controlled, repeat-dose study in CF subjects with Pa. Intravenous 10mg/kg KB001-A or placebo infusions were administered at baseline and weeks 2, 4, 8, and 16, with a 4-week follow-up. Sputum inflammatory markers were assessed in a sub-study. Time-to-need for antibiotics was compared between groups by Kaplan Meier analysis and Cox proportional hazards modeling adjusting for randomization strata.RESULTSOf 182 subjects, 169 received at least one infusion of KB001-A (n=83) or placebo (n=86). KB001-A was generally safe and well-tolerated as compared to placebo, with no significant emergent adverse effects other than one serious adverse event of elevated hepatic enzymes of unclear etiology. Time to need for antibiotics did not differ between groups (HR: 1.00; 95% CI: 0.69, 1.45, p=0.995). A 3.2 increase in ppFEV₁ from placebo favoring KB001-A was observed at week 16 (95% CI: 1.12, 5.30, p=0.003). Mean changes from baseline in log₁₀ sputum neutrophil elastase (NE) had a non-significant decrease (-0.27, 95% CI: -0.58,0.04, p=0.084) while IL-8 concentrations at week 16 were significantly lower (-0.27, 95% CI: -0.55,0.00, p=0.048) among KB001-A subjects (n=16) relative to placebo (n=13).CONCLUSIONSKB001-A was safe and well-tolerated and associated with a modest FEV₁ benefit and reduction in select sputum inflammatory markers (IL-8). KB001-A was not associated with an increased time to need for antibiotics. The lack of efficacy seen with KB001-A may be due, in part, to the low levels of the type III secretion proteins previously reported in sputum of CF patients chronically infected with Pa.

2014-10-03·Human Vaccines & Immunotherapeutics3区 · 医学

Anti-PcrV antibody strategies against virulentPseudomonas aeruginosa

3区 · 医学

Article

作者: Haight, Matthew ; Ito, Emi ; Sawa, Teiji ; Nguyen, Vinh Huu

Pseudomonas aeruginosa is an opportunistic bacterial pathogen that causes fatal acute lung infections in critically ill individuals. Its pathogenesis is associated with bacterial virulence conferred by the type III secretion system (TTSS), through which P. aeruginosa causes necrosis of the lung epithelium and disseminates into the circulation, resulting in bacteremia, sepsis, and mortality. TTSS allows P. aeruginosa to directly translocate cytotoxins into eukaryotic cells, inducing cell death. The P. aeruginosa V-antigen PcrV, a homolog of the Yersinia V-antigen LcrV, is an indispensable contributor to TTS toxin translocation. Vaccination against PcrV ensures the survival of challenged mice and decreases lung inflammation and injury. Both the rabbit polyclonal anti-PcrV antibody and the murine monoclonal anti-PcrV antibody, mAb166, inhibit TTS toxin translocation. mAb166 IgG was cloned, and a molecular engineered humanized anti-PcrV IgG antigen-binding fragment, KB001, was developed for clinical use. KB001 is currently undergoing Phase-II clinical trials for ventilator-associated pneumonia in France and chronic pneumonia in cystic fibrosis in USA. In these studies, KB001 has demonstrated its safety, a favorable pharmacokinetic profile, and promising potential as a nonantibiotic strategy to reduce airway inflammation and damage in P. aeruginosa pneumonia.

100 项与 Rivabazumab pegol 相关的药物交易

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研发状态

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
囊性纤维化	临床2期	新西兰	Humanigen, Inc.	2012-12-01
囊性纤维化	临床2期	澳大利亚	Humanigen, Inc.	2012-12-01
囊性纤维化	临床2期	美国	Humanigen, Inc.	2012-12-01
囊性纤维化	临床2期	以色列	Humanigen, Inc.	2012-12-01
呼吸机相关性肺炎	临床2期	法国	Humanigen, Inc.	2008-04-01
假单胞菌感染	临床2期	法国	Humanigen, Inc.	2008-04-01
铜绿假单胞菌感染	临床2期	美国	Humanigen, Inc.	2008-03-01

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临床结果

适应症

分期

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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


NCT01695343 (Pubmed \| J Cyst Fibros) 人工标引	临床2期	铜绿假单胞菌感染 \| 囊性纤维化	169	KB001-A	範願憲鹽窪膚鹹齋製齋(淵餘廠選獵願製壓構醖) = Time to need for antibiotics did not differ between groups 範襯齋艱積壓淵鑰範獵 (顧鏇衊衊夢衊積窪網鑰 ) 更多	积极	2018-07-01
				Placebo