Goflikicept(Goflikicept) - 药物靶点：IL-1β_在研适应症：复发性特发性心包炎，新型冠状病毒感染，回归热_专利_临床

概要

基本信息

药物类型

融合蛋白

别名

靶点

IL-1β

作用方式

抑制剂

作用机制

IL-1β抑制剂(白细胞介素-1β抑制剂)

治疗领域

感染心血管疾病呼吸系统疾病+ [3]

在研适应症

复发性特发性心包炎新型冠状病毒感染回归热+ [2]

非在研适应症

炎症疼痛原发性痛风+ [5]

原研机构

R-Pharm JSC

在研机构

R-Pharm JSCR-Pharm Overseas, Inc.R-Pharm International, LLC

+ [1]

非在研机构

R-Pharm Group

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构/序列

Sequence Code 9964977

来源: *****

Sequence Code 774056835

来源: *****

关联

11

项与 Goflikicept 相关的临床试验

NCT05107934

/ Suspended临床2/3期

International, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis

The primary purpose of this study is the evaluation of the efficacy and safety of RPH-104 treatment in patients with recurrent pericarditis.
Pharmacokinetic and pharmacodynamic parameters of RPH-104 multiple doses in this patient population will be assessed as well.

开始日期2025-12-01

申办/合作机构

R-Pharm Overseas, Inc.

[+2]

NCT05432960

/ Withdrawn临床3期

International, Multi-Center, Double-blind, Randomized, Placebo-Controlled, Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)

The primary objective of the study is to evaluate the efficacy of RPH-104 when administered at a dose of 160 mg on Day 0, Day 7, Day 21 and then once every 2 weeks (Q2W) subcutaneous (SC) in patients with Adult Onset Still's Disease (AOSD). Furthermore, the study is scheduled to investigate pharmacokinetic (PK) and pharmacodynamic (PD) parameters of RPH-104.

开始日期2023-12-01

申办/合作机构

R-Pharm International, LLC

[+2]

NCT04213274

/ Withdrawn临床2期

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome

The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the local laboratory C-reactive protein (CRP) result

开始日期2023-05-01

申办/合作机构

R-Pharm Overseas, Inc.

[+1]

100 项与 Goflikicept 相关的临床结果

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100 项与 Goflikicept 相关的转化医学

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100 项与 Goflikicept 相关的专利（医药）

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10

项与 Goflikicept 相关的文献（医药）

2024-08-13·Circulation

Results of International, Double-Blind, Randomized, Placebo-Controlled, Phase IIa Study of Interleukin-1 Blockade With RPH-104 (Goflikicept) in Patients With ST-Segment–Elevation Myocardial Infarction (STEMI)

Letter

作者: Meray, Imad ; Staroverov, Ilya ; Bogin, Vlad ; Rozanov, Denis ; Cremer, Paul C. ; Selezneva, Natalia ; Ponomar, Ekaterina G. ; Mekhriakov, Sergei ; Lonchakova, Oxana ; Pereverzeva, Kristina ; Safarian, Vakhtang ; Popov, Nikolay ; Agirov, Murat ; Abbate, Antonio ; Savelieva, Ekaterina ; Golino, Michele ; Duhanina, Ekaterina ; Buono, Marco Giuseppe Del ; Babaeva, Lala ; Kotova, Anastasia ; Markley, Roshanak ; Fedash, Andrey ; Privalova, Olga ; Mayorov, Vyacheslav ; Zyuryaev, Ilya ; Yakushin, Sergey ; Kalimulin, Denis ; Ivanova, Galina ; Zubova, Ekaterina ; Talasaz, Azita H. ; Marawan, Amr ; Lavrovsky, Yan ; Taylor, Angela ; Pevzner, Dmitry V. ; Grishin, Sergey A. ; Samsonov, Mikhail Yu ; Novosadov, Vladimir ; Osmanova, Samra ; Nilk, Rostislav ; Pisaryuk, Alexandra ; Kalashnikov, Igor ; Shogenov, Zaur ; Van Tassell, Benjamin ; Lapin, Oleg ; Yurkovskiy, Andrey ; Damonte, Juan Ignacio ; Thomas, Georgia ; Turlington, Jeremy S. ; Egorova, Alina N. ; Kornilov, Egor ; Privalov, Dmitry V. ; Pravkina, Ekaterina ; Seleznev, Sergey

2024-08-01·JACC: Cardiovascular Imaging

Pericardial Diseases

Review

作者: Luis, Sushil Allen ; Kwon, Deborah H ; Tan, Carmela D ; Brucato, Antonio ; Rodriugez, E Rene ; Hoit, Brian ; Mardigyan, Vartan ; Weber, Brittany ; Imazio, Massimo ; Lin, David ; LeWinter, Martin ; Asher, Craig ; Adler, Yehuda ; Ordovas, Karen G ; Chetrit, Michael ; Oh, Jae K ; Jellis, Christine L ; Cremer, Paul C ; Wang, Tom Kai Ming ; Schenone, Aldo L ; Abbate, Antonio ; Klein, Allan L

Pericardial diseases have gained renewed clinical interest, leading to a renaissance in the field. There have been many recent advances in pericardial diseases in both multimodality cardiac imaging of diagnoses, such as recurrent, transient constrictive and effusive-constrictive pericarditis, and targeted therapeutics, especially anti-interleukin (IL)-1 agents that affect the inflammasome as part of autoinflammatory pathophysiology. There remains a large educational gap for clinicians, leading to variability in evaluation and management of these patients. The latest pericardial imaging (American Society of Echocardiography, European Association of Cardiovascular Imaging) and clinical guidelines (European Society of Cardiology) are >8-10 years of age and may not reflect current practice. Recent clinical trials involving anti-IL-1 agents in recurrent pericarditis, including anakinra (AIRTRIP), rilonacept (RHAPSODY), and goflikicept have demonstrated their efficacy. The present document represents an international position statement from world leaders in the pericardial field, focusing on novel concepts and emphasizing the role of multimodality cardiac imaging as well as new therapeutics in pericardial diseases.

2023-09-01·Current cardiology reports

Paradigm Shift in Diagnosis and Targeted Therapy in Recurrent Pericarditis.

Review

作者: Wang, Tom Kai Ming ; Dong, Tiffany ; Klein, Allan L

PURPOSE OF THE REVIEWWe review the pathophysiology, diagnosis, and contemporary treatment for recurrent pericarditis, with focus on interleukin-1 (IL-1) inhibitors.RECENT FINDINGSRecurrent pericarditis occurs in about 15-30% of patients who have acute pericarditis. With increased understanding of the autoinflammatory pathophysiology of recurrent pericarditis, IL-1 inhibitors including anakinra, canakinumab, and rilonacept have been applied to this condition with great promise. In particular, the RHAPSODY trial found rilonacept significantly improves pain and inflammation, while also reducing recurrence with few adverse events. The next IL-1 inhibitor on the block for pericarditis, goflikicept, is also discussed. Understanding the role of the inflammasome via the autoinflammatory pathway in pericarditis has led to incorporation of IL-1 inhibitors in the treatment of recurrent pericarditis, with proven efficacy and safety and randomized trials. This will lead to increase uptake of this agent which demonstrated lower rates of recurrence and faster time to resolution.

1

项与 Goflikicept 相关的新闻（医药）

2021-01-21

·BioSpace

R-Pharm to study RPH-104 in acute ST-Elevation Myocardial Infarction

Moscow, January 21st, 2021. R-Pharm announces first patients enrolled in international double blind placebo-controlled clinical trial of RPH-104 in acute ST-Elevation Myocardial Infarction (STEMI). The study will enroll 102 patients in Russia and the USA receiving single subcutaneous injection. Thereafter patients will stay under cardiologist supervision for one year in order to evaluate the effect on parameters of systemic inflammation and disease outcomes. Mikhail Samsonov, Chief Medical Officer, R-Pharm: “Acute myocardial infarction is the most prevalent form of coronary heart disease characterized by high mortality. Interleukin-1 (IL-1) plays important role in inflammatory response after myocardial infarction and is involved in cardiac remodeling. Inflammatory response contributes to further cardiac damage and is a predictor of increased risk of death or heart failure. We believe that inhibition of IL-1 by RPH-104 could lead to better outcomes in patients with STEMI.” RPH-104 is an original biological drug developed at the R-Pharm laboratory in the USA, which is a new heterodimeric protein inhibiting IL-1. The drug is developed for the treatment of a number of socially significant and orphan diseases characterized by systemic inflammation, including acute myocardial infarction, Schnitzler syndrome, COVID-19, recurrent pericarditis, familial Mediterranean fever, and gout. The United States Food and Drug Administration (US FDA) has designated RPH-104 as orphan for the treatment of Schnitzler syndrome. There are currently no drugs approved by the FDA for the treatment of Schnitzler syndrome. ST-segment elevation myocardial infarction (STEMI) is a clinical syndrome of acute myocardial ischemia and necrosis associated with high risk of in-hospital and long-term morbidity and mortality. According to the European Register, mortality among patients with STEMI can exceed 12% over 6 months, during the first year is about 10% and over 5 years can reach 20%. About R-Pharm Group Headquartered in Moscow, Russia, R-Pharm Group is an integrated specialty pharmaceutical company, focused on research and development, manufacturing and commercialization of pharmaceuticals, laboratory equipment and medical devices. R-Pharm was founded in 2001 and occupies leading positions in the Russian healthcare market ever since. Operating in more than 30 countries and having a big number of production facilities in Russia and CIS, a plant in Germany and a research lab in the USA, R-Pharm succeeds in manufacturing and distributing of medicines to treat cancer, viral infections, autoimmune and other severe diseases to meet patients` needs. Media Contact: Valeria Andronenkova – Global Communications Specialist, R-Pharm Group andronenkova@rpharm.ru Mobile: +7 9166249614

100 项与 Goflikicept 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16396

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性特发性心包炎	临床3期	俄罗斯	R-Pharm JSC	2020-12-11
复发性特发性心包炎	临床3期	俄罗斯	R-Pharm International, LLC	2020-12-11
新型冠状病毒感染	临床3期	-	TRPHARM Ilaç Sanayi Tic. AS	-
严重急性呼吸综合征	临床申请	俄罗斯	R-Pharm International, LLC	2020-04-23
SARS-CoV-2 急性呼吸道疾病	临床申请	俄罗斯	R-Pharm Group	2020-04-09
心包炎	临床申请	俄罗斯	R-Pharm Group	2020-03-05
疼痛	临床申请	俄罗斯	TRPHARM Ilaç Sanayi Tic. AS	2018-03-23
复发性心包炎	临床前	美国	R-Pharm Overseas, Inc.	2025-12-01
成人斯蒂尔病	临床前	俄罗斯	R-Pharm International, LLC	2023-12-01
原发性痛风	临床前	俄罗斯	R-Pharm JSC	2018-03-26

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04067492 (CTgov)	临床2期	原发性痛风	47	RPH - 104 (RPH - 4 mg)	範選範網鏇襯繭艱網膚(積顧製淵衊鬱顧壓襯艱) = 獵選窪膚願顧簾艱願顧糧壓淵繭築製簾憲簾獵 (簾網簾選範範鬱網構遞, 構艱襯簾鑰夢衊夢遞衊 ~ 窪構齋範糧繭壓餘鬱範) 更多	-	2022-07-25
				RPH - 104 (RPH - 20 mg)	範選範網鏇襯繭艱網膚(積顧製淵衊鬱顧壓襯艱) = 獵餘簾觸築觸鹹淵繭膚糧壓淵繭築製簾憲簾獵 (簾網簾選範範鬱網構遞, 襯夢選鬱製餘醖範繭構 ~ 選獵夢夢憲鏇糧壓鬱糧) 更多
NCT04380519 (CTgov)	临床2/3期	新型冠状病毒感染 \| 严重急性呼吸综合征	372	RPH-104 80 mg (RPH -104 80 mg)	獵鑰衊憲顧蓋鏇選簾觸(網膚憲蓋觸鬱簾構窪蓋) = 壓齋膚衊製廠簾簾網顧獵構顧獵觸範膚膚淵構 (顧衊鑰築網醖襯蓋艱鹹, 構廠膚醖鹹壓齋鬱鹽蓋 ~ 選蓋窪願鹽範糧鹽淵艱) 更多	-	2022-01-24
				Olokizumab 64 mg (Olokizumab 64 mg)	獵鑰衊憲顧蓋鏇選簾觸(網膚憲蓋觸鬱簾構窪蓋) = 築範淵艱夢獵淵網蓋選獵構顧獵觸範膚膚淵構 (顧衊鑰築網醖襯蓋艱鹹, 獵窪蓋築醖膚夢範鏇築 ~ 鹽夢觸淵膚衊製觸齋網) 更多
NCT02667639 (CTgov)	临床1期	-	35	RPH-104 (Treatment)	(淵糧願繭築鑰衊構壓製) = 獵艱壓遞築艱艱鬱膚廠網網憲鏇壓憲鏇鹹繭餘 (範壓鹹窪淵壓選壓鹹顧, 鏇夢製衊鏇製齋鬱範糧 ~ 鏇膚憲鏇糧艱廠廠齋鹽) 更多	-	2019-10-04
				Sodium chloride Sterile Injection 0.9% w/v (Placebo)	(淵糧願繭築鑰衊構壓製) = 蓋鑰選蓋繭顧鏇齋網鹹網網憲鏇壓憲鏇鹹繭餘 (範壓鹹窪淵壓選壓鹹顧, 鏇淵齋顧製齋鹹衊鹽網 ~ 艱蓋獵夢遞糧淵齋糧鹹) 更多