Last update 27 Dec 2024
Eflimrufusp alfa
Last update 27 Dec 2024
Overview
Basic Info
Drug Type Antibody fusion proteins |
Synonyms RC-28, RC-28-E, RC28-E |
Target |
Mechanism VEGF inhibitors(Vascular endothelial growth factor inhibitors), bFGF inhibitors(Fibroblast growth factor 2 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationSpecial Review Project (CN) |
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Gene Sequence
Sequence Code 524756270
Source: *****
Related
12
Clinical Trials associated with Eflimrufusp alfaA Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
RC28-E注射液治疗糖尿病性黄斑水肿的多中心、随机、双盲、阳性对照的Ⅲ期临床试验
[Translation] A multicenter, randomized, double-blind, positive-controlled phase III clinical trial of RC28-E injection in the treatment of diabetic macular edema
A Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RC28-E 2mg Versus Aflibercept in Subjects With Wet Age-Related Macular Degeneration
100 Clinical Results associated with Eflimrufusp alfa
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100 Translational Medicine associated with Eflimrufusp alfa
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100 Patents (Medical) associated with Eflimrufusp alfa
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7
Literatures (Medical) associated with Eflimrufusp alfa01 Sep 2024Ophthalmology and Therapy
Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial
Article
Author: Jiang, Qin ; Ha, Shaoping ; Chen, He ; Li, Zhuo ; Dai, Hong ; Wu, Chan ; Lu, Yingyi ; Wang, Wenxiang ; Chen, Youxin ; Bi, Yanlong ; Fang, Jianmin ; Zhang, Han ; Liu, Xiaoling ; Zhang, Yifan ; Yu, Xiaobing ; Zhu, Dan ; Li, Lin
INTRODUCTION:
To assess the safety and efficacy of repeated intravitreal injections of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in patients with neovascular age-related macular degeneration (AMD). This was a prospective, multicenter, open-label clinical trial; 37 patients with choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) letter scores between 73 and 34 were enrolled.
METHODS:
Treatment regimens consisted of a 3-month loading phase and a pro re nata (PRN) maintenance phase. This study included three treatment groups: the 0.5, 1.0, and 2.0 mg RC28-E groups, with escalating doses ranging from 0.5 to 2.0 mg. Patients were evaluated monthly for 48 weeks. Safety was assessed based on ocular and systemic adverse events (AEs), pharmacokinetic characteristics, and the presence of anti-RC28-E antibodies. Efficacy was assessed using the mean change in BCVA and central subfield thickness (CST) from baseline to week 48.
RESULTS:
Most AEs were mild or moderate. The most common AE was a minor injection-related subconjunctival hemorrhage (16.2%). The AEs did not increase with dose or repeated injections. At week 48, mean improvements in BCVA from baseline in the 0.5, 1.0, and 2.0 mg groups were 6.1 ± 8.3, 9.9 ± 10.7, and 7.6 ± 9.38 letters, respectively; mean reductions in CST in the three groups were 112.1 ± 160.5, 175.1 ± 212.4, and 128.7 ± 145.8 μm, respectively. The serum RC28-E concentrations in 95% of the patients were below the quantification limit of the assay. No significant change from baseline was observed in the mean plasma concentrations of VEGF or FGF over the 48 weeks of treatment. Pre-treatment antibodies to RC28-E were detected in 1 of the 37 patients. Antibodies to RC28-E were detected in two patients after dosing with RC28-E for 48 weeks.
CONCLUSION:
RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.
01 Jan 2020Experimental eye researchQ3 · MEDICINE
In vivo characterization of RC28-E, a fusion protein targeting VEGF and bFGF: Pharmacokinetics and ocular distribution in primates
Q3 · MEDICINE
Article
Author: Huang, Min ; Kou, Xiangying ; Jiang, Jing ; Li, Hongzhen ; Liu, Zhihao ; Wu, Chuandong ; Wang, Ling
Administration of RC28-E, a VEGF/bFGF dual decoy receptor (IgG1 Fc-fusion protein), have shown relative therapeutic value in ocular in vivo models, including laser-induced choroidal neovascularization (CNV) in monkeys and streptozotocin (STZ)-induced diabetic retinopathy (DR) in rats. In the present study, we have elucidated the pharmacokinetics profiles of RC28-E at the systemic, vitreous and aqueous humor after administration in a primate model (Macaca fascicularis). Moreover, here we tease out the ocular tissue distribution of RC28-E after intravitreal administration, and we also determine the systemic bioavailability after both intravitreal and intravenous administration. Our results show that RC28-E is rapidly and well-distributed into ocular tissues after intravitreal administration. Drug exposure in choroid and retina was approximately one-quarter and one-twelfth of that in vitreous humor, while its half-life in vitreous and aqueous humor were well-sustained (3.3 and 3.0 days). Remarkably, RC28-E could cross the blood-ocular barrier, and the systemic bioavailability of RC28-E was ~25%. No drug accumulation after multiple administration was noticed, but low titers of antibody produce against RC28-E were detected. Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy.
18 Jun 2018International journal of ophthalmologyQ4 · MEDICINE
Protective effects of a novel drug RC28-E blocking both VEGF and FGF2 on early diabetic rat retina
Q4 · MEDICINE
ArticleOA
Author: Li, Xiao-Rong ; Jiang, Jing ; Wang, Ling ; Bo, Qi-Yu ; Zhang, Xiao-Min ; Yu, Guang-Wei ; Ru, Yu-Sha ; Han, Qian ; Yang, Qian-Hui ; Liu, Xun ; Fang, Jian-Min ; Wu, Mian-Mian ; Huang, Min ; Zhang, Yan
AIM:
To investigate protective effects of a novel recombinant decoy receptor drug RC28-E on retinal damage in early diabetic rats.
METHODS:
The streptozotocin (STZ)-induced diabetic rats were randomly divided into 6 groups: diabetes mellitus (DM) group (saline, 3 µL/eye); RC28-E at low (0.33 µg/µL, 3 µL), medium (1 µg/µL, 3 µL), and high (3 µg/µL, 3 µL) dose groups; vascular endothelial growth factor (VEGF) Trap group (1 µg/µL, 3 µL); fibroblast growth factor (FGF) Trap group (1 µg/µL, 3 µL). Normal control group was included. At week 1 and 4 following diabetic induction, the rats were intravitreally injected with the corresponding solutions. At week 6 following the induction, apoptosis in retinal vessels was detected by TUNEL staining. Glial fibrillary acidic protein (GFAP) expression was examined by immunofluorescence. Blood-retinal barrier (BRB) breakdown was assessed by Evans blue assay. Ultrastructural changes in choroidal and retinal vessels were analyzed by transmission electron microscopy (TEM). Content of VEGF and FGF proteins in retina was measured by enzyme linked immunosorbent assay (ELISA). The retinal expression of intercellular cell adhesion molecule-1 (ICAM-1), tumor necrosis factor-α (TNF-α), VEGF and FGF genes was examined by quantitative polymerase chain reaction (qPCR).
RESULTS:
TUNEL staining showed that the aberrantly increased apoptotic cells death in diabetic retinal vascular network was significantly reduced by treatments of medium and high dose RC28-E, VEGF Trap, and FGF Trap (all P<0.05), the effects of medium and high dose RC28-E or FGF Trap were greater than VEGF Trap (P<0.01). GFAP staining suggested that reactive gliosis was substantially inhibited in all RC28-E and VEGF Trap groups, but the inhibition in FGF Trap group was not as prominent. Evans blue assay demonstrated that only high dose RC28-E could significantly reduce vascular leakage in early diabetic retina (P<0.01). TEM revealed that the ultrastructures in choroidal and retinal vessels were damaged in early diabetic retina, which was ameliorated to differential extents by each drug. The expression of VEGF and FGF2 proteins was significantly upregulated in early diabetic retina, and normalized by RC28-E at all dosages and by the corresponding Traps. The upregulation of ICAM-1 and TNF-α in diabetic retina was substantially suppressed by RC28-E and positive control drugs.
CONCLUSION:
Dual blockade of VEGF and FGF2 by RC28-E generates remarkable protective effects, including anti-apoptosis, anti-gliosis, anti-leakage, and improving ultrastructures and proinflammatory microenvironment, in early diabetic retina, thereby supporting further development of RC28-E into a novel and effective drug to diabetic retinopathy (DR).
1
News (Medical) associated with Eflimrufusp alfa12 May 2021
100 Deals associated with Eflimrufusp alfa
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetic macular oedema | Phase 3 | CN | 08 Jun 2023 | |
| Wet age-related macular degeneration | Phase 3 | CN | 14 Mar 2023 | |
| Nonproliferative diabetic retinopathy | Phase 2 | CN | 25 May 2021 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 1 | - | vjftmjovls(xuhtyjzeof) = Patients using Rongchang BioRC28 demonstrated good tolerability and safety, with significant improvements in vision and disease, and were effective in patients who had previously received anti-VEGF therapy and PCV (fundus polypoid choroidal vasculopathy). eilgxgdixt (fgstypcpho ) | Positive | 15 Sep 2022 | |||
Not Applicable | - | - | qzkvisbspd(jumuspxsia) = hkpdxiorvo pjiguiopvb (yvwdvkguyr ) View more | - | 01 Mar 2012 |
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