预约演示
更新于：2024-12-27
Sozinibercept
更新于：2024-12-27
概要
基本信息
药物类型 融合蛋白 |
别名 soluble VEGFR-3、sozinibercept、OPT-302 + [1] |
作用机制 VEGF-C抑制剂(血管内皮生长因子C抑制剂)、VEGF-D抑制剂(血管内皮生长因子D抑制剂) |
在研适应症 |
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)- |
特殊审评快速通道 (美国) |
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结构/序列
Sequence Code 9733459
来源: *****
关联
7
项与 Sozinibercept 相关的临床试验CTRI/2021/10/037507
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) - COAST
CTRI/2021/10/037451
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) - ShORe
NCT04757636
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD
100 项与 Sozinibercept 相关的临床结果
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100 项与 Sozinibercept 相关的转化医学
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100 项与 Sozinibercept 相关的专利（医药）
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17
项与 Sozinibercept 相关的文献（医药）2024-12-19Translational Vision Science & Technology
Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema
Article
作者: Baldwin, Megan E. ; Boyer, David S. ; Gupta, Sunil ; Crawford, Courtney ; Stone, Cameron M. ; Leitch, Ian M. ; Dugel, Pravin U. ; Pearlman, Joel A. ; Steinle, Nathan C.
Purpose:
Sozinibercept inhibits vascular endothelial growth factors (VEGFs) C and D. This study evaluated outcomes following switching from anti-VEGF-A monotherapy to intravitreal injections of three dose levels of sozinibercept in combination with aflibercept in patients with diabetic macular edema (DME).
Methods:
A phase 1b, open-label, multicenter dose-escalation study with a 24-week follow-up. Patients received 3 loading doses of aflibercept (2 mg) in combination with sozinibercept (0.3, 1, or 2 mg) once every 4 weeks and were followed through week 24. The primary endpoint was safety, and secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomic changes on imaging.
Results:
Nine patients received sozinibercept in combination with aflibercept after a mean (SD) of 6.3 (2.4) injections of previous anti-VEGF-A. Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities. Mean change in BCVA at week 12 was +7.7 letters (95% confidence interval [CI], 2-13.3) from baseline (65 letters [SD 5.5]) with a dose response for increasing doses of sozinibercept. At week 12, central subfield thickness (CST) was decreased by -71 µm (95% CI, -117 to -26) from baseline (434 µm [SD 58]), and 6 of 9 (67%) patients had a ≥50% reduction in excess foveal thickness.
Conclusions:
In prior-treated patients with center-involved DME, switching to sozinibercept in combination with aflibercept was well tolerated with improved visual and anatomic outcomes.
Translational Relevance:
This first-in-human study builds upon basic research by providing safety and preliminary efficacy of sozinibercept (anti-VEGF-C/-D) in combination with aflibercept for DME.
2024-04-12EXPERT OPINION ON PHARMACOTHERAPY
Perspectives on the currently available pharmacotherapy for wet macular degeneration
Review
作者: Kumar, Aneeta ; Ting, Magdalene Yin Lin ; Ferro Desideri, Lorenzo ; Anguita, Rodrigo
INTRODUCTION:
Wet age-related macular degeneration (w-AMD) is a leading cause of visual impairment globally, with its prevalence expected to rise alongside increasing life expectancy. The current standard treatment involves frequent intravitreal injections of anti-VEGF agents, which although revolutionary, pose significant burdens on both patients and healthcare services.
AREAS COVERED:
This review explores current and emerging pharmaceutical treatments for w-AMD, focusing on their pharmacokinetics, pharmacodynamics, efficacy, and safety. Promising developments include extending treatment intervals with newer anti-VEGF agents like brolucizumab and faricimab, biosimilars offering cost-effective options, and exploring innovative drug delivery methods such as subretinal gene therapy. Combination therapies, gene therapies, and novel agents like KSI-301 and OPT-302 show potential for improving treatment outcomes and reducing treatment burden.
EXPERT OPINION:
While current treatments for w-AMD have significantly advanced with the advent of anti-VEGF therapies, their limitations in terms of treatment burden and incomplete responses have spurred research into diverse alternative approaches. These innovative strategies offer hope for improving patient outcomes and reducing healthcare burdens, suggesting a promising future for w-AMD management.
2023-11-01Cellular signalling
SAR131675 exhibits anticancer activity on human ovarian cancer cells through inhibition of VEGFR-3/ERK1/2/AKT signaling pathway
Article
作者: Babaei, Zeinab ; Parsian, Hadi ; Aghaei, Mahmoud ; Panjehpour, Mojtaba
Vascular endothelial growth factor receptor-3 (VEGFR-3) is known to participate in tumorigenesis and lymphangiogenesis, and as such, has the potential to serve as a molecular target for cancer therapy. SAR131675 is a highly selective VEGFR-3 antagonist that has an inhibitive effect on lymphatic cell growth. However, the anticancer effects and underlying mechanisms of SAR131675 in ovarian cancer remain poorly understood. In this study, we investigated the pathological role of VEGFR-3, and the effects of SAR131675 on proliferation, cell cycle, migration, and apoptosis in ovarian cancer cells. Our results showed that the mRNA and protein of VEGFR-3 were expressed in OVCAR3 and SKOV3 ovarian cancer cells, and this receptor was activated following stimulation with 50 ng/ml VEGF-C Cys156Ser (VEGF-CS), a selective ligand for VEGFR-3. Enhancing VEGFR-3 phosphorylation by treatment of ovarian cancer cells with VEGF-CS resulted in increased levels of phosphorylated extracellular signal-regulated kinases 1/2 (ERK1/2) and AKT. Moreover, our data demonstrated that SAR131675 inhibited VEGF-CS-mediated proliferation, colony formation, and migration of cancer cells in a dose-dependent manner. In addition, inhibition of VEGFR-3 activation with SAR131675 significantly increased cell cycle arrest and promoted apoptosis in both OVCAR3 and SKOV3 cells. Mechanistically, SAR131675 effectively suppressed the VEGF-CS-induced phosphorylation of VEGFR-3 and its downstream effectors including activated ERK1/2 and AKT in ovarian cancer cells. Our results reveal an anticancer activity of SAR131675 on the growth and migration of ovarian cancer cells, which may be through inhibiting VEGFR-3/ERK1/2/AKT pathway. SAR131675 may serve as an effective targeted drug for ovarian cancer.
82
项与 Sozinibercept 相关的新闻（医药）100 项与 Sozinibercept 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 |
|---|---|---|---|---|
| 湿性年龄相关性黄斑变性 | 临床3期 | 美国 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 阿根廷 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 澳大利亚 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 奥地利 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 巴西 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 保加利亚 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 加拿大 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 哥伦比亚 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 克罗地亚 | 2021-03-12 | |
| 湿性年龄相关性黄斑变性 | 临床3期 | 捷克 | 2021-03-12 |
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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 | 66 | 壓繭製簾糧鹹鬱衊積選(簾築餘鏇憲積淵鑰鏇選) = 繭鑰鏇廠醖膚獵壓遞網 製艱遞選醖願窪鬱憲餘 (鬱淵鑰壓壓簾膚鹹繭夢 ) 更多 | 积极 | 2024-09-19 | |||
壓繭製簾糧鹹鬱衊積選(簾築餘鏇憲積淵鑰鏇選) = 醖憲壓範鏇醖網遞鑰願 製艱遞選醖願窪鬱憲餘 (鬱淵鑰壓壓簾膚鹹繭夢 ) | |||||||
临床1/2期 | 153 | aflibercept+OPT-302 (Ph 1b: 2.0 mg Aflibercept With 0.3 mg OPT-302) | 窪鏇壓齋醖艱獵蓋淵觸(餘衊憲願壓餘鹹醖顧鹽) = 鑰淵範蓋夢醖鹽獵糧範 夢蓋夢糧顧鹹鏇糧獵觸 (構觸壓鏇膚夢繭蓋鹽廠, 範鹹蓋餘構積鹹壓簾遞 ~ 顧獵鑰鹹顧製網積憲糧) 更多 | - | 2022-06-22 | ||
aflibercept+OPT-302 (Ph 1b: 2.0 mg Aflibercept With 1.0 mg OPT-302) | 窪鏇壓齋醖艱獵蓋淵觸(餘衊憲願壓餘鹹醖顧鹽) = 鬱獵觸齋鹽窪鹹餘獵廠 夢蓋夢糧顧鹹鏇糧獵觸 (構觸壓鏇膚夢繭蓋鹽廠, 憲齋艱觸選壓蓋鑰顧齋 ~ 醖壓廠淵鬱艱衊構廠製) 更多 | ||||||
临床2期 | 115 | Aflibercept+OPT-302 | 齋夢鹹夢構襯糧窪選獵(艱鑰鹽蓋選選鬱鑰蓋遞) = 廠遞憲觸鏇廠醖膚艱範 夢鏇膚淵觸糧鏇遞簾範 (鹹網憲壓顧鹽願糧艱鏇 ) 更多 | 积极 | 2020-06-09 | ||
Aflibercept+Sham Procedure | 齋夢鹹夢構襯糧窪選獵(艱鑰鹽蓋選選鬱鑰蓋遞) = 鬱簾選範壓製淵遞醖願 夢鏇膚淵觸糧鏇遞簾範 (鹹網憲壓顧鹽願糧艱鏇 ) 更多 | ||||||
临床1期 | 51 | 壓襯繭製網網壓壓願遞(構夢遞簾衊鏇醖顧醖艱) = 衊範範製鑰鬱觸範醖齋 壓衊艱齋顧廠齋膚艱醖 (願餘選糧齋夢艱觸網構 ) | 积极 | 2020-03-01 | |||
ranibizumab+OPT-302 | 壓襯繭製網網壓壓願遞(簾構繭範夢餘範觸鹽鬱) = 觸鬱網網憲願顧製顧膚 憲廠壓壓夢齋構製獵淵 (鹽積淵蓋顧衊鹽醖選積, 3 ~ 7) 更多 |
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