瑞替莫德(Reltecimod) - 药物靶点：CD28 x PLK1_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Reltecimod (USAN/INN)、Reltecimod Sodium

+ [1]

靶点

CD28 x PLK1

作用方式

抑制剂

作用机制

CD28抑制剂(T细胞特异性表面糖蛋白CD28抑制剂)、PLK1抑制剂(Polo样激酶1抑制剂)

治疗领域

感染消化系统疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症-

非在研适应症

脓毒症所致急性肾损伤坏死性筋膜炎Fournier坏疽+ [2]

原研机构

Atox Bio Ltd.

在研机构-

非在研机构

Atox Bio Ltd.

Korea Basic Science Institute

权益机构-

最高研发阶段终止临床3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/序列

分子式C46H72N10O15S

InChIKeyVRNHFZYMPDKTBS-WYUJEMNCSA-N

CAS号1447799-33-8

Sequence Code 525674730

来源: *****

关联

4

项与瑞替莫德相关的临床试验

NCT03403751

/ Terminated临床3期

Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

开始日期2018-05-24

申办/合作机构

Atox Bio Ltd.

NCT02469857

/ Completed临床3期

Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

开始日期2015-12-01

申办/合作机构

Atox Bio Ltd.

[+1]

NCT01417780

/ Completed临床2期

Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections

A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

开始日期2011-12-01

申办/合作机构

Atox Bio Ltd.

100 项与瑞替莫德相关的临床结果

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100 项与瑞替莫德相关的转化医学

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100 项与瑞替莫德相关的专利（医药）

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20

项与瑞替莫德相关的文献（医药）

2021-08-01·Journal of Trauma and Acute Care Surgery

Resolution of organ dysfunction as a predictor of long-term survival in necrotizing soft tissue infections: Analysis of the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections trial and a retrospective claims database-linked chart study

Article

作者: Walker, Valery ; Maislin, Greg ; Andrade, Katherine E ; Wilfret, David A ; May, Addison K ; Brakenridge, Scott C ; Bulger, Eileen M ; Dankner, Wayne M

BACKGROUNDNecrotizing soft tissue infections (NSTIs) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation, and aggressive surgical management have significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction.METHODSWe performed a combined analysis of NSTI patients from the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections randomized-controlled interventional trial (ATB-202) and comprehensive administrative database (ATB-204) to determine the association of persistent organ dysfunction on inpatient and long-term outcomes. Persistent organ dysfunction was defined as a modified Sequential Organ Failure Assessment (mSOFA) score of 2 or greater at Day 14 (D14) after NSTI diagnosis, and resolution of organ dysfunction defined as mSOFA score of 1 or less.RESULTSThe analysis included 506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204. In both study cohorts, age and comorbidity burden were higher in the D14 mSOFA ≥2 group. Patients with D14 mSOFA score of 1 or less had significantly lower 90-day mortality than those with mSOFA score of 2 or higher in both ATB-202 (2.4% vs. 21.5%; p < 0.001) and ATB-204 (6% vs. 16%: p = 0.008) studies. In addition, in an adjusted covariate analysis of the combined study data sets D14 mSOFA score of 1 or lesss was an independent predictor of lower 90-day mortality (odds ratio, 0.26; 95% confidence interval, 0.13–0.53; p = 0.001). In both studies, D14 mSOFA score of 1 or less was associated with more favorable discharge status and decreased resource utilization.CONCLUSIONFor patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality. Promoting the resolution of acute organ dysfunction after NSTI should be considered as a target for investigational therapies to improve long-term outcomes after NSTI.LEVEL OF EVIDENCEPrognostic/epidemiology study, level III

2020-12-01·International Journal of Peptide Research and Therapeutics

Prolonged Benefit of Reltecimod Despite Short Plasma Half-Life

作者: Anat Shirvan ; Rotem Edgar ; Dalia Hillman ; Raymond Kaempfer ; Avi Cohen

Abstract: Reltecimod (previously AB103 or p2TA) is a short-peptide mimetic of the CD28 costimulatory receptor on T cells that attenuates CD28/B7-2 signaling, which are responsible for the hyperinflammatory response that is observed during severe infections.A single-dose of reltecimod provides sustained survival benefit in animal models of sepsis and clin. benefit in patients with necrotizing soft tissue infections.Here, the pharmacokinetic/pharmacodynamics profile of reltecimod was evaluated to determine the basis of its sustained single-dose effect.The half-life of reltecimod was assessed using bioanal. methods in different animals, and the biodistribution was studied in male BALB/c mice that were administered a single i.v. dose of [¹⁴C]-reltecimod.Blood partitioning was performed, and the minimal time to observe efficacy of reltecimod was evaluated in vitro.The plasma half-life of reltecimod was short in humans and all tested animal models, ranging from 1 to 8 min.Upon leaving the blood vessels, reltecimod quickly redistributed to lymphatic tissues, where T cells are produced and exposed to antigens.Lymphatic concentration of reltecimod was 22 times higher than plasma concentration by 20 min post-administration, and reltecimod was enriched in the white blood cell fraction of blood (6.8% after 2 h).Reltecimod had a rapid onset of effect (5 min) that lasted for at least 12 h based on levels of IFN-γ that were secreted by antigen-activated human peripheral blood mononuclear cells.This suggests that reltecimod's prolonged clin. benefits are based on fast distribution to target organs and rapid intervention with signaling pathways, irresp. of its short residence time in the plasma.

2020-09-01·Annals of Surgery1区 · 医学

A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI)

1区 · 医学

Article

作者: Fagenholz, Peter ; Toschlog, Eric ; Wilfret, David ; Maislin, Greg ; Bulger, Eileen M ; Bernard, Andrew C ; Evans, David C ; Green, John M ; May, Addison K ; Sperry, Jason L ; Martin, Niels D ; Robinson, Bryce R H ; Henry, Sharon ; Dankner, Wayne M

Background and Objective:Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI.Methods:Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding.Results:Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ± 15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ± 2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.Conclusion:Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.

1

项与瑞替莫德相关的新闻（医药）

2021-05-24

·GlobeNewswire

Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies

Los Angeles, USA, May 24, 2021 (GLOBE NEWSWIRE) -- Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies Ceftobiprole Medocaril under Phase III trials is expected to turn out to be the most effective treatment of Acute Bacterial Skin and Skin Structure Infections. DelveInsight’s ‘Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Pipeline Insights’ report offers a detailed picture of the ABSSSI emerging therapies expected to enter the Acute Bacterial Skin and Skin Structure Infections market along with detailed coverage of the pipeline therapies under development in pre-clinical as well as clinical stages of development, partnerships taking place in the domain, recent happenings in space and growth prospects across the Diabetes domain. Some of the key highlights of the ABSSSI Pipeline report: Request for Sample to know more about the therapies that are set to grab maximum patient pool @ ABSSSI Emerging Therapies and Forecast Acute Bacterial Skin and Skin Structure Infection is a bacterial infection of the skin and associated tissues. The FDA defines skin and skin structure infections as an acute bacterial skin and skin structure infection or ABSSSI if the infection is accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2, accompanied by lymph node enlargement or systemic symptoms such as fever ≥38°C (100.4°F). Some of the most common bacterial pathogens that cause Acute Bacterial Skin and Skin Structure Infections are Streptococcus pyogenes and Staphylococcus aureus, including methicillin-resistant S.aureus. Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram Negative bacteria. The severity of Acute Bacterial Skin and Skin Structure Infections has led to an increasing emphasis on the identification of novel strategies to treat this disease. For more information on emerging drugs, visit Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis ABSSSI Pipeline Drugs Request for Sample to know more @ Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis, Key Companies and Futuristic Trends Acute Bacterial Skin and Skin Structure Infections Drugs and Therapeutic Assessment The ABSSSI Pipeline report presents comprehensive insights into active ABSSSI pipeline assets segmented by Stage, ABSSSI Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Reach out for Rich and Deep Market Assessment and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Basilea Pharmaceutica, TenNor Therapeutics, Innovation Pharmaceuticals, Debiopharm Group, MicuRx Pharmaceuticals, Taxis Pharmaceuticals, Botanix pharmaceuticals, Motif Bio, KBP Biosciences, Atox Bio and others. Key ABSSSI Pipeline Therapies: Ceftobiprole medocaril, TNP-2092, Brilacidin, Afabicin, Contezolid acefosamil, TXA709, Cannabidiol, KBP-7072, Nemonoxacin, AB-103 and others. Reach out @ Acute Bacterial Skin and Skin Structure Infections Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ ABSSSI Emerging Therapies Related ReportsAcute Bacterial Skin And Skin Structure Infections MarketDelveInsight's "Acute Bacterial Skin and Skin Structure Infections - Market Insights, Epidemiology, and Market Forecast-2030" report. Acne Vulgaris MarketDelveInsight's "Acne Vulgaris Market Insights, Epidemiology, and Market Forecast-2030" report. Moderate To Severe Atopic Dermatitis MarketDelveInsight's "Moderate to Severe Atopic Dermatitis (AD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Acral Lentiginous Melanoma MarketDelveInsight's "Acral lentiginous melanoma - Market Insights, Epidemiology, and Market Forecast-2030" report. Androgenetic Alopecia MarketDelveInsight's "Androgenetic Alopecia Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts ABSSSI Market and Key Treatments Atopic Dermatitis MarketRosacea Pipeline and Therapies Marijuana Clinical TrialsOpiate Withdrawal Cocktail About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

100 项与瑞替莫德相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11281	-	-	-

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
脓毒症所致急性肾损伤	临床3期	法国	Atox Bio Ltd.	2018-05-24
脓毒症所致急性肾损伤	临床3期	美国	Atox Bio Ltd.	2018-05-24
腹膜炎	临床3期	法国	Atox Bio Ltd.	2018-05-24
腹膜炎	临床3期	美国	Atox Bio Ltd.	2018-05-24
坏死性筋膜炎	临床3期	美国	Atox Bio Ltd.	2015-12-01
坏死性筋膜炎	临床3期	法国	Atox Bio Ltd.	2015-12-01
Fournier坏疽	临床3期	法国	Atox Bio Ltd.	2015-12-01
Fournier坏疽	临床3期	美国	Atox Bio Ltd.	2015-12-01
软组织感染	临床3期	美国	Atox Bio Ltd.	2015-12-01
软组织感染	临床3期	法国	Atox Bio Ltd.	2015-12-01

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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


NCT01417780 (CTgov)	临床2期	软组织感染	43	AB103 (AB103 0.25 mg/kg)	憲衊壓蓋鹹夢鹽蓋鹽艱(鹽簾廠顧艱構築簾膚夢) = 構獵鹹窪積範襯構選顧淵憲襯襯範獵獵獵積夢 (簾製構簾鑰鹹鏇遞選構, 蓋繭顧膚夢願積蓋鹹簾 ~ 鹽壓網選壓艱簾獵餘網) 更多	-	2021-08-18
				AB103 (AB103 0.5 mg/kg)	憲衊壓蓋鹹夢鹽蓋鹽艱(鹽簾廠顧艱構築簾膚夢) = 顧願淵顧憲繭積獵衊衊淵憲襯襯範獵獵獵積夢 (簾製構簾鑰鹹鏇遞選構, 簾鏇簾夢鏇範選壓獵醖 ~ 壓遞製積鹽願顧糧遞鹹) 更多
NCT01166984 (CTgov)	临床1期	-	25	AB103 (AB103 7.5 µg/kg)	繭艱積顧範觸壓積獵憲(積憲醖鹽鏇壓齋衊醖鹽) = 廠齋鬱鹽顧膚齋選簾積糧廠鹽鬱憲蓋夢廠構簾 (齋積獵憲鏇壓繭窪遞蓋, 鹽糧製膚衊遞醖顧鹽觸 ~ 範獵齋壓範齋顧膚鬱築) 更多	-	2021-04-27
				AB103 (AB103 37.5 µg/kg)	繭艱積顧範觸壓積獵憲(積憲醖鹽鏇壓齋衊醖鹽) = 淵壓顧夢繭艱淵鬱衊選糧廠鹽鬱憲蓋夢廠構簾 (齋積獵憲鏇壓繭窪遞蓋, 衊鏇齋鹹願鏇艱醖構窪 ~ 獵襯窪鬱鹽簾鬱鹽蓋糧) 更多