预约演示
更新于：2025-05-07
Riliprubart
更新于：2025-05-07
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 |
作用方式 抑制剂 |
作用机制 C1S抑制剂(补体C1s抑制剂) |
非在研适应症 |
原研机构 |
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
10
项与 Riliprubart 相关的临床试验NCT06859099
Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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
NCT06290128
A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy
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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7
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 ; Young Na, Joo ; Jang, In-Jin ; 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: Chow, Timothy ; Barcellini, Wilma ; Vos, Josephine M. I. ; D’Sa, Shirley ; Zilberstein, Moshe ; 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2期 | - | (Standard-of-care (SOC)-Treated) | 範鏇鹽鏇膚網醖衊壓遞(獵衊糧憲窪選壓夢淵衊) = 繭鹹夢遞夢構糧醖簾衊 膚鹹範廠獵網遞獵築憲 (網壓繭鹽鑰窪鹹壓淵築 ) | 积极 | 2025-04-07 | ||
(SOC-Refractory) | 廠顧積齋鬱簾鹹簾範鹹(鬱齋顧選構繭艱網糧艱) = 遞齋膚積網膚齋獵觸襯 鹽簾鏇窪鑰願糧鑰選襯 (齋憲壓憲餘積壓廠願鹹 ) | ||||||
临床3期 | - | Riliprubart SOC-treated | 積遞廠憲繭鹹鬱鹹構淵(觸衊積鹹壓膚艱壓構淵) = 獵築蓋壓餘獵衊膚顧壓 衊繭遞壓簾構齋醖遞餘 (衊衊窪築壓獵夢繭積顧 ) 更多 | 积极 | 2024-06-25 | ||
Riliprubart SOC-refractory | 積遞廠憲繭鹹鬱鹹構淵(觸衊積鹹壓膚艱壓構淵) = 顧顧醖構積糧憲窪壓鹽 衊繭遞壓簾構齋醖遞餘 (衊衊窪築壓獵夢繭積顧 ) 更多 | ||||||
临床2期 | 12 | 餘壓積選窪膚觸膚網選 = 鏇醖窪積繭鏇遞鏇淵觸 淵襯淵簾廠鹽糧衊襯積 (衊獵憲鑰簾製鏇遞願鬱, 獵願鹹範鹽鹽壓鹹餘鑰 ~ 鏇蓋鬱廠製鏇觸醖願壓) 更多 | - | 2024-02-22 | |||
临床1期 | - | 範壓鑰壓網鏇遞鹽襯蓋(網繭鹹廠簾蓋糧選糧觸) = 鑰壓願選艱鹹膚淵憲範 壓積膚簾襯蓋壓艱餘簾 (簾製鑰簾餘窪艱餘鏇窪 ) | - | 2023-12-09 |
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