预约演示
更新于：2025-02-13
Riliprubart
更新于：2025-02-13
概要
基本信息
药物类型 单克隆抗体 |
别名 BIVV 020、BIVV-020、SAR-445088 + [1] |
靶点 |
作用机制 C1S抑制剂(补体C1s抑制剂) |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国)、突破性疗法 (中国) |
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结构/序列
Sequence Code 432293646H
来源: *****
Sequence Code 432293647L
来源: *****
关联
15
项与 Riliprubart 相关的临床试验CTIS2023-508338-33-00
A Phase 3, randomized, double-blind study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy - EFC18156
NCT06290141
A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy
CTR20242000
一项在慢性炎性脱髓鞘性多发性神经根神经病受试者中评价 riliprubart 对比静脉注射免疫球蛋白（IVIg）的疗效和安全性的 Ⅲ 期、随机、双盲研究
100 项与 Riliprubart 相关的临床结果
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100 项与 Riliprubart 相关的转化医学
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100 项与 Riliprubart 相关的专利（医药）
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6
项与 Riliprubart 相关的文献（医药）2024-10-02EXPERT OPINION ON INVESTIGATIONAL DRUGS
Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose riliprubart, an anti-C1s humanized monoclonal antibody in East-Asian adults: results from a Phase 1, randomized, open-label trial
Article
作者: Zhao, Amy ; Zhu, Yunting ; Tang, Lei ; Oh, Jaeseong ; Jang, In-Jin ; Young Na, Joo ; Li, Yingxin
OBJECTIVES:
This Phase 1 trial was planned to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single dose of riliprubart in healthy East-Asian adult participants.
METHODS:
A single-center, parallel-group, randomized, open-label, single-dose study was performed to evaluate the PK, PD, safety, and tolerability of riliprubart (50 mg/kg intravenous [IV] or 600 mg subcutaneous [SC]) in 37 healthy East-Asian (Chinese, Japanese, and Korean) participants.
RESULTS:
Riliprubart was slowly absorbed after SC administration (median tmax: 7.01-10.48 days) and showed a long half-life after IV or SC administration (mean: 9.52-11.0 weeks), with a bioavailability of 74.6% after SC administration. The PD profiles, which are evaluated by classical complement pathway activity or CH50, were similar and largely overlapped across East-Asian participants after a single IV or SC dose. Riliprubart was safe and well tolerated in participants following a single IV or SC dose.
CONCLUSIONS:
Riliprubart was safe and well tolerated and demonstrated favorable PK and PD profiles in healthy East-Asian participants following a single IV or SC dose. These results are comparable to first-in-human study results from non-East-Asian participants and support the same dosing regimen of riliprubart for global simultaneous clinical development.
CLINICAL TRIAL REGISTRATION:
This trial is registered at https://cris.nih.go.kr (identifier: KCT0006571).
2024-02-22Blood
Safety, tolerability, and activity of the active C1s antibody riliprubart in cold agglutinin disease: a phase 1b study
Article
作者: Vos, Josephine M. I. ; Chow, Timothy ; Barcellini, Wilma ; Zilberstein, Moshe ; D’Sa, Shirley ; Röth, Alexander ; Barker, Graham ; Storek, Michael ; Perrin, Laurent ; Wardęcki, Marek
Abstract:
Cold agglutinin disease is a rare autoimmune hemolytic anemia characterized by complement pathway-mediated hemolysis. Riliprubart (SAR445088, BIVV020), a second-generation classical complement inhibitor, is a humanized monoclonal antibody that selectively inhibits only the activated form of C1s. This Phase 1b study evaluated the safety, tolerability, and effect on hemolysis of riliprubart in adult patients with cold agglutinin disease. On day 1, 12 patients received a single IV dose of either 30 mg/kg (n = 6) or 15 mg/kg (n = 6) of riliprubart and were subsequently followed for 15 weeks. Riliprubart was generally well tolerated; there were no treatment-emergent serious adverse events, or treatment-emergent adverse events leading to death or permanent study discontinuation. There were no reports of serious infections, encapsulated bacterial infections including meningococcal infections, hypersensitivity, or thromboembolic events. Rapid improvements in hemoglobin (day 5) and bilirubin (day 1) were observed in both treatment cohorts. Mean hemoglobin levels were maintained at >11.0 g/dL from day 29 and mean levels of bilirubin were normalized by day 29; both responses were maintained throughout the study. Improvements in clinical markers closely correlated with a sustained reduction in the 50% hemolytic complement (CH50) throughout the study. Mean C4 levels, an in vivo marker of treatment activity, increased 1 week after treatment with either dose of riliprubart and were sustained throughout the study. In conclusion, a single IV dose of riliprubart was well tolerated, and led to rapid classical complement inhibition, control of hemolysis, and improvement in anemia, all of which were sustained over 15 weeks. This trial was registered at www.ClinicalTrials.gov as #NCT04269551.
2023-06-01Clinical immunology (Orlando, Fla.)
Anti-C1s humanized monoclonal antibody SAR445088: A classical pathway complement inhibitor specific for the active form of C1s
Article
作者: Parry, Graham C. ; Panicker, Sandip ; Hussain, Sami ; Storek, Michael ; Chan, Joanne ; Byun, Tony S. ; Simmons, Ken T. ; Rose, Eileen L. ; Markham, Kate
The objective of this study was to characterize the complement-inhibiting activity of SAR445088, a novel monoclonal antibody specific for the active form of C1s. Wieslab® and hemolytic assays were used to demonstrate that SAR445088 is a potent, selective inhibitor of the classical pathway of complement. Specificity for the active form of C1s was confirmed in a ligand binding assay. Finally, TNT010 (a precursor to SAR445088) was assessed in vitro for its ability to inhibit complement activation associated with cold agglutinin disease (CAD). TNT010 inhibited C3b/iC3b deposition on human red blood cells incubated with CAD patient serum and decreased their subsequent phagocytosis by THP-1 cells. In summary, this study identifies SAR445088 as a potential therapeutic for the treatment of classical pathway-driven diseases and supports its continued assessment in clinical trials.
100 项与 Riliprubart 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 美国 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 中国 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 日本 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 阿根廷 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 比利时 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 巴西 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 加拿大 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 捷克 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 丹麦 | 2024-08-21 | |
| 多灶性获得性脱髓鞘性感觉和运动神经病 | 临床3期 | 德国 | 2024-08-21 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | Riliprubart SOC-treated | 獵糧壓製膚艱廠獵網醖(壓窪觸鏇憲顧蓋觸鏇夢) = 構鑰廠鑰淵構憲鑰壓膚 糧齋觸壓選糧醖觸襯鏇 (鬱艱壓網繭膚襯襯選願 ) 更多 | 积极 | 2024-06-25 | ||
Riliprubart SOC-refractory | 獵糧壓製膚艱廠獵網醖(壓窪觸鏇憲顧蓋觸鏇夢) = 繭襯獵壓蓋網願顧選膚 糧齋觸壓選糧醖觸襯鏇 (鬱艱壓網繭膚襯襯選願 ) 更多 | ||||||
临床2期 | 12 | 餘獵糧獵齋衊願餘鏇範(醖範憲醖蓋鹹繭簾醖艱) = 願憲選衊遞簾繭顧繭簾 憲窪廠憲膚遞製獵願壓 (遞鏇構遞窪鏇蓋齋淵艱, 衊齋憲願襯遞蓋夢範襯 ~ 鬱齋衊繭廠簾艱鏇鏇窪) 更多 | - | 2024-02-22 | |||
临床1期 | - | 顧鑰糧遞蓋範願製夢齋(觸簾襯蓋範艱糧鹹鏇觸) = 餘簾窪壓構觸壓鹽餘齋 壓構艱獵製製顧範齋糧 (積範築醖鑰蓋夢選膚積 ) | - | 2023-12-09 |
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