更新于：2024-06-23
Reltecimod
瑞替莫德
更新于：2024-06-23
概要
基本信息
药物类型 合成多肽 |
别名 Reltecimod (USAN/INN)、Reltecimod Sodium、AB-103 + [1] |
靶点 |
作用机制 CD28抑制剂(T细胞特异性表面糖蛋白CD28抑制剂) |
在研适应症- |
非在研适应症 |
原研机构 |
在研机构- |
非在研机构 |
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- |
结构
分子式C46H72N10O15S |
InChIKeyVRNHFZYMPDKTBS-WYUJEMNCSA-N |
CAS号1447799-33-8 |
序列信息
Sequence Code 525674730
来源: *****
关联
4
项与 瑞替莫德 相关的临床试验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 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)
Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
100 项与 瑞替莫德 相关的临床结果
登录后查看更多信息
100 项与 瑞替莫德 相关的转化医学
登录后查看更多信息
100 项与 瑞替莫德 相关的专利（医药）
登录后查看更多信息
17
项与 瑞替莫德 相关的文献（医药）2021-08-01The 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: Brakenridge, Scott C. ; Maislin, Greg ; Wilfret, David A. ; Dankner, Wayne M. ; Walker, Valery ; May, Addison K. ; Bulger, Eileen M. ; Andrade, Katherine E.
BACKGROUND:
Necrotizing 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.
METHODS:
We 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.
RESULTS:
The 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.
CONCLUSION:
For 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 EVIDENCE:
Prognostic/epidemiology study, level III
2020-09-01Annals of surgery1区 · 医学
Commentary on “Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod”
1区 · 医学
Article
作者: Nathens, Avery B
2020-09-01Annals of surgery1区 · 医学
A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI)
1区 · 医学
Article
作者: Green, John M ; Henry, Sharon ; Toschlog, Eric ; Evans, David C ; Dankner, Wayne M ; May, Addison K ; Sperry, Jason L ; Fagenholz, Peter ; Wilfret, David ; Bulger, Eileen M ; Bernard, Andrew C ; Maislin, Greg ; Robinson, Bryce R H ; Martin, Niels D
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）100 项与 瑞替莫德 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11281 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 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 | 美国 | 2018-05-24 | |
| 脓毒症所致急性肾损伤 | 临床3期 | 法国 | 2018-05-24 | |
| 腹膜炎 | 临床3期 | 美国 | 2018-05-24 | |
| 腹膜炎 | 临床3期 | 法国 | 2018-05-24 | |
| 坏死性筋膜炎 | 临床3期 | 美国 | 2015-12-01 | |
| 坏死性筋膜炎 | 临床3期 | 法国 | 2015-12-01 | |
| Fournier坏疽 | 临床3期 | 美国 | 2015-12-01 | |
| Fournier坏疽 | 临床3期 | 法国 | 2015-12-01 | |
| 软组织感染 | 临床3期 | 美国 | 2015-12-01 | |
| 软组织感染 | 临床3期 | 法国 | 2015-12-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 43 | (AB103 0.25 mg/kg) | 鬱積憲製網鬱觸醖夢遞(構糧窪艱鬱淵製壓獵顧) = 淵簾蓋齋艱網鹹鏇願繭 繭遞獵鬱積餘醖遞廠膚 (憲顧淵繭鏇襯範顧窪壓, 艱積襯襯願鏇簾夢糧糧 ~ 選簾網願鹹醖遞鬱築憲) 更多 | - | 2021-08-18 | ||
(AB103 0.5 mg/kg) | 鬱積憲製網鬱觸醖夢遞(構糧窪艱鬱淵製壓獵顧) = 艱鑰窪夢鹽襯構蓋淵構 繭遞獵鬱積餘醖遞廠膚 (憲顧淵繭鏇襯範顧窪壓, 齋鏇構齋願艱鹽遞鬱鑰 ~ 憲齋製膚鹹壓艱鹹夢膚) 更多 | ||||||
临床1期 | - | 25 | (AB103 7.5 µg/kg) | 積積蓋艱製鹽繭範醖選(糧選繭壓願鬱齋衊繭鹽) = 願襯構簾齋觸壓艱願廠 選選願網餘艱鬱獵製鬱 (夢憲壓蓋選憲夢範鹽鏇, 築遞製簾築構積鑰憲鬱 ~ 製繭遞鹹鬱鑰網膚鹽鹽) 更多 | - | 2021-04-27 | |
(AB103 37.5 µg/kg) | 積積蓋艱製鹽繭範醖選(糧選繭壓願鬱齋衊繭鹽) = 醖願壓鬱鏇鹽觸範製積 選選願網餘艱鬱獵製鬱 (夢憲壓蓋選憲夢範鹽鏇, 願鬱選齋築餘鑰願蓋淵 ~ 夢艱壓衊襯壓窪鬱襯範) 更多 | ||||||
临床3期 | 290 | 窪觸構壓鏇憲範網憲範(鑰鹹鬱壓願蓋鹹選窪糧) = 選選夢觸積衊鹹醖鏇選 獵鏇製鬱構積艱製構壓 (憲製積獵衊遞糧鏇築鏇 ) | 积极 | 2020-07-08 | |||
Placebo | 窪觸構壓鏇憲範網憲範(鑰鹹鬱壓願蓋鹹選窪糧) = 襯廠鬱壓鏇廠構廠壓鑰 獵鏇製鬱構積艱製構壓 (憲製積獵衊遞糧鏇築鏇 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用