Edratide(Edratide) - 药物靶点：APRIL x IFNγ x IL-1β x TNF-α x caspase 8_在研适应症：系统性红斑狼疮_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Edratide (USAN/INN)

靶点

APRIL x IFNγ x IL-1β x TNF-α x caspase 8

作用机制

APRIL抑制剂(肿瘤坏死因子配体超家族成员13抑制剂)、IFNγ抑制剂(干扰素-γ抑制剂)、IL-1β抑制剂(白细胞介素-1β抑制剂)

+ [3]

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

系统性红斑狼疮

非在研适应症

干燥综合征

原研机构

Weizmann Institute of Science

在研机构

Weizmann Institute of Science

非在研机构

Teva Pharmaceutical Industries Ltd.

XTL Biopharmaceuticals Ltd.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C111H149N27O28

InChIKeyVXXZQHUWZSRPAM-CDJUQFLLSA-N

CAS号433922-67-9

序列信息

Sequence Code 75657

来源: *****

关联

3

项与 Edratide 相关的临床试验

EUCTR2005-001391-12-GB / Not yet recruiting临床2期

A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE

开始日期2005-10-12

申办/合作机构

Teva Pharmaceutical Industries Ltd.

EUCTR2005-001391-12-IT / Not yet recruitingN/A

A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients

开始日期2005-07-28

申办/合作机构

Teva Italia SRL

NCT00203151 / Terminated临床2期

A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)

It is thought that Edratide may be able to reduce the symptoms of SLE.

开始日期2005-07-01

申办/合作机构

Teva Branded Pharmaceutical Products R&D, Inc.

100 项与 Edratide 相关的临床结果

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100 项与 Edratide 相关的转化医学

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100 项与 Edratide 相关的专利（医药）

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10

项与 Edratide 相关的文献（医药）

2015-08-01·Lupus Science & Medicine3区 · 医学

Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study

3区 · 医学

ArticleOA

作者: Urowitz, Murray B ; Isenberg, David A ; Wallace, Daniel J

ObjectiveTo evaluate the safety and efficacy of hCDR1 (Edratide) in patients with systemic lupus erythematosus (SLE).MethodsPatients (n=340) with SLE ≥4 ACR criteria (4–11, mean 7) with active disease (SLEDAI-2K of 6–12). Patients were on average 7.1 years post-diagnosis and their organ involvement was mainly musculoskeletal, mucocutaneous and haematologic. Placebo or Edratide was administered subcutaneously weekly at doses of 0.5, 1.0 or 2.5 mg. The co-primary endpoints were SLEDAI-2K SLE Disease Activity and Adjusted Mean SLEDAI (AMS) reduction in patients compared with controls using a landmark analysis. Secondary outcomes were improvement in British Isles Lupus Assessment Group (BILAG) Responder Index and medicinal flare analysis.ResultsEdratide was safe and well tolerated. The primary endpoints based solely on SLEDAI-2K and AMS were not met. The secondary predefined endpoint, BILAG, was met for the 0.5 mg Edratide arm in the intention to treat (ITT) cohort (N=316) (OR=2.09, p=0.03) with trends in the 1.0 and 2.5 mg doses. There was also a positive trend in the Composite SLE Responder Index of the ITT cohort. Post hoc analysis showed that the BILAG secondary endpoint was also met for the 0.5 mg Edratide for a number of subgroup dose levels, including low or no steroids, seropositivity and patients with 2 grade BILAG improvement.ConclusionsThe favourable safety profile and encouraging clinically significant effects noted in some of the endpoints support the need for additional longer term Edratide studies that incorporate recent advances in the understanding and treatment of SLE, including steroid treatment algorithms, and using a composite primary endpoint which is likely to include BILAG.Trial registration numberNCT00203151.

2014-11-01·Journal of Autoimmunity1区 · 医学

Novel approaches to the development of targeted therapeutic agents for systemic lupus erythematosus

1区 · 医学

Review

作者: Sthoeger, Zev ; Sharabi, Amir ; Mozes, Edna

Systemic lupus erythematosus (SLE) is a chronic multisystem disease in which various cell types and immunological pathways are dysregulated. Current therapies for SLE are based mainly on the use of non-specific immunosuppressive drugs that cause serious side effects. There is, therefore, an unmet need for novel therapeutic means with improved efficacy and lower toxicity. Based on recent better understanding of the pathogenesis of SLE, targeted biological therapies are under different stages of development. The latter include B-cell targeted treatments, agents directed against the B lymphocyte stimulator (BLyS), inhibitors of T cell activation as well as cytokine blocking means. Out of the latter, Belimumab was the first drug approved by the FDA for the treatment of SLE patients. In addition to the non-antigen specific agents that may affect the normal immune system as well, SLE-specific therapeutic means are under development. These are synthetic peptides (e.g. pConsensus, nucleosomal peptides, P140 and hCDR1) that are sequences of conserved regions of molecules involved in the pathogenesis of lupus. The peptides are tolerogenic T-cell epitopes that immunomodulate only cell types and pathways that play a role in the pathogenesis of SLE without interfering with normal immune functions. Two of the peptides (P140 and hCDR1) were tested in clinical trials and were reported to be safe and well tolerated. Thus, synthetic peptides are attractive potential means for the specific treatment of lupus patients. In this review we discuss the various biological treatments that have been developed for lupus with a special focus on the tolerogenic peptides.

2009-08-01·Journal of Autoimmunity1区 · 医学

Treatment of lupus patients with a tolerogenic peptide, hCDR1 (Edratide): Immunomodulation of gene expression

1区 · 医学

Article

作者: Heidy Zinger ; Amir Sharabi ; Edna Mozes ; Zev M. Sthoeger ; Molly Dayan ; Yair Molad ; Ilan Asher

Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by dysregulation of cytokines, apoptosis, and B- and T-cell functions. The tolerogenic peptide, hCDR1 (Edratide), ameliorated the clinical manifestations of murine lupus via down-regulation of pro-inflammatory cytokines and apoptosis, up-regulation of the immunosuppressive cytokine TGF-beta, and the induction of regulatory T-cells. In the present study, gene expression was determined in peripheral blood mononuclear cells of 9 lupus patients that were treated for 26 weeks with either hCDR1 (five patients), or placebo (four patients). Disease activity was assessed by SLEDAI-2K and the BILAG scores. Treatment with hCDR1 significantly down-regulated the mRNA expression of the pathogenic cytokines IL-1beta, TNF-alpha, IFN-gamma, and IL-10, of BLyS (B-lymphocyte stimulator) and of the pro-apoptotic molecules caspase-3 and caspase-8. In contrast, the treatment up-regulated in vivo gene expression of both TGF-beta and FoxP3. Furthermore, hCDR1 treatment resulted in a significant decrease in SLEDAI-2K (from 8.0+/-2.45 to 4.4+/-1.67; P=0.02) and BILAG (from 8.2+/-2.7 to 3.6+/-2.9; P=0.03) scores. Thus, the tolerogenic peptide hCDR1, immunomodulates, in vivo, the expression of genes that play a role in SLE, consequently restoring the global immune dysregulation of lupus patients. Hence, hCDR1 has a potential role as a novel disease-specific treatment for lupus patients.

1

项与 Edratide 相关的新闻（医药）

2022-11-08

·Business Wire

Systemic Lupus Erythematosus (SLE) Update Bulletin 2022: Gain Insights on the Latest Events Happening in the Treatment Landscape - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Systemic Lupus Erythematosus (SLE): Update Bulletin #2" newsletter has been added to ResearchAndMarkets.com's offering. Gain new key opinion leader (KOL) insights on the latest events happening in Systemic Lupus Erythematosus (SLE) treatment landscape. Topics covered include expert opinions on the prospects of the Phase III BLISS-BELIEVE study which will assess co-administration of SC Benylsta (GSK's belimumab) and a single cycle of IV Rituxan/MabThera (rituximab; Roche/Biogen). The KOLs also imparted their views on the results of a Phase II study investigating Stelara (ustekinumab; Janssen Biotech) for the treatment of SLE, and the potential for XTL Biopharmaceuticals' edratide as well as Corbus Pharmaceuticals's anabasum. Business Questions: How do KOLs view the combination of belimumab and rituximab for the treatment of SLE? Do KOLs harbour any concerns about combining these two biologic agents? How do experts view the results of ustekinumab's Phase II study? What advantages does ustekinumab have over other pipeline SLE agents? How do KOLs perceive edratide's mechanism of action and preliminary trial results? How optimistic are KOLs about edratide's prospects as a treatment for SLE? Do KOLs perceive anabasum's mechanism of action to be promising? How do KOLs view this agent's safety profile? For more information about this newsletter visit https://www.researchandmarkets.com/r/rggx5q

100 项与 Edratide 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03957	-	-	DB15272

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
干燥综合征	临床2期	以色列	XTL Biopharmaceuticals Ltd.	-
系统性红斑狼疮	临床2期	欧盟	Teva Pharmaceutical Industries Ltd.	-
系统性红斑狼疮	临床2期	-	Weizmann Institute of Science	-
系统性红斑狼疮	临床2期	俄罗斯	Teva Pharmaceutical Industries Ltd.	-
系统性红斑狼疮	临床前	俄罗斯	Teva Pharmaceutical Industries Ltd.	-
系统性红斑狼疮	临床前	欧盟	Teva Pharmaceutical Industries Ltd.	-