RPH-104(RPH-104) - 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，心包炎_专利_临床

概要

基本信息

药物类型

融合蛋白

别名

Goflikicept

靶点

IL-1β

作用机制

IL-1β抑制剂(白细胞介素-1β抑制剂)

治疗领域

感染呼吸系统疾病免疫系统疾病+ [5]

在研适应症

复发性特发性心包炎新型冠状病毒感染心包炎+ [6]

非在研适应症

疼痛原发性痛风SARS-CoV-2 急性呼吸道疾病+ [2]

原研机构

TRPHARM Ilaç Sanayi Tic. AS

在研机构

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

+ [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-

序列信息

Sequence Code 9964977

来源: *****

Sequence Code 9964965

来源: *****

关联

11

项与 RPH-104 相关的临床试验

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

[+1]

NCT05107934 / Not yet recruiting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2023-12-01

申办/合作机构

R-Pharm Overseas, Inc.

[+2]

NCT04213274 / Not yet recruiting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 RPH-104 相关的临床结果

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100 项与 RPH-104 相关的转化医学

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100 项与 RPH-104 相关的专利（医药）

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7

项与 RPH-104 相关的文献（医药）

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 ; Schenone, Aldo L ; Abbate, Antonio ; Wang, Tom Kai Ming ; 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.

2023-07-01·Journal of the American College of Cardiology

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept

Article

作者: Maslyanskiy, Alexey L ; Lavrovsky, Yan ; Grishin, Sergey A ; Schedrova, Margarita L ; Gleykina, Ekaterina V ; Egorova, Alina N ; Samsonov, Mikhail Yu ; Abbate, Antonio ; Myachikova, Valentina Yu ; Moiseeva, Olga M ; Vinogradova, Oksana V

BACKGROUNDIdiopathic recurrent pericarditis (IRP) is a rare autoinflammatory disease. Interleukin (IL)-1α and IL-1β are the pivotal cytokines in the pathophysiology of acute pericarditis and its recurrence. We created a phase II/III study with a new IL-1 inhibitor-goflikicept in IRP.OBJECTIVESThis study sought to evaluate the efficacy and safety of goflikicept treatment in patients with IRP.METHODSWe conducted a 2-center open-label study of goflikicept in patients with IRP with and without recurrence at time of enrollment. The study consisted of 4 periods: screening, run-in (open-label treatment period), randomized withdrawal, and follow-up. Patients with clinical response to goflikicept in the run-in period were randomized (1:1) to a placebo-controlled withdrawal period, where the time to first pericarditis recurrence (primary endpoint) was evaluated.RESULTSWe enrolled 22 patients, and 20 of these patients were randomized. Reduction of C-reactive protein level accompanied by reduction of chest pain and pericardial effusion compared to baseline was demonstrated during the run-in period. Recurrence of pericarditis occurred in 9 of 10 patients in the placebo group, and there were no recurrence events in goflikicept group within 24 weeks after randomization (P < 0.001). A total of 122 adverse events were reported in 21 patients (95.5%), with no deaths and no new safety signals identified for goflikicept.CONCLUSIONSTreatment with goflikicept prevented recurrences and maintained IRP remission with a favorable risk-benefit ratio. Goflikicept reduced the risk of recurrence compared with placebo. (Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis; NCT04692766).

1

项与 RPH-104 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 RPH-104 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	-
成人斯蒂尔病	临床前	俄罗斯	R-Pharm International, LLC	2023-12-01
心肌梗塞	临床前	俄罗斯	R-Pharm Group	2020-12-06
严重急性呼吸综合征	临床前	俄罗斯	R-Pharm International, LLC	2020-04-23
SARS-CoV-2 急性呼吸道疾病	临床前	俄罗斯	R-Pharm Group	2020-04-09
心包炎	临床前	俄罗斯	R-Pharm Group	2020-03-05
原发性痛风	临床前	俄罗斯	R-Pharm JSC	2018-03-26
疼痛	临床前	俄罗斯	TRPHARM Ilaç Sanayi Tic. AS	2018-03-23

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临床结果

适应症

分期

评价

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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)	餘築鑰選積遞襯醖艱壓(淵遞範遞淵簾鏇築鹽餘) = 獵醖積鹹蓋鹽廠獵範鑰廠糧憲廠鑰蓋鹽簾選獵 (醖獵憲願廠鏇齋願醖壓, 鏇鹹遞糧襯築襯構製窪 ~ 觸構鹹廠製餘範願襯顧) 更多	-	2022-07-25
				RPH - 104 (RPH - 20 mg)	餘築鑰選積遞襯醖艱壓(淵遞範遞淵簾鏇築鹽餘) = 遞選夢憲憲襯觸窪鏇鹽廠糧憲廠鑰蓋鹽簾選獵 (醖獵憲願廠鏇齋願醖壓, 積觸廠糧選艱壓艱築鬱 ~ 廠壓鏇鑰獵衊築憲窪憲) 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)	願鹹淵艱獵憲築鹹簾夢(遞築糧鬱齋壓顧觸觸積) = 選襯獵選餘淵鏇鏇範廠築獵願範繭鬱壓淵蓋糧 (窪襯膚網醖築廠鬱範衊, 簾顧繭築衊繭廠糧齋窪 ~ 襯簾鏇鑰遞顧顧顧製遞) 更多	-	2022-01-24
				Olokizumab 64 mg (Olokizumab 64 mg)	願鹹淵艱獵憲築鹹簾夢(遞築糧鬱齋壓顧觸觸積) = 網鬱範壓鑰鹹醖獵蓋獵築獵願範繭鬱壓淵蓋糧 (窪襯膚網醖築廠鬱範衊, 襯艱壓壓餘觸遞餘醖簾 ~ 繭廠醖襯糧遞壓觸構壓) 更多
NCT02667639 (CTgov)	临床1期	-	35	RPH-104 (Treatment)	鹽糧艱選襯糧蓋鑰蓋餘(遞齋鑰廠鏇襯繭願鹽鏇) = 襯鹹餘觸憲糧簾觸觸鏇網簾簾衊鹹積壓糧築廠 (鹽鹹艱製築淵範襯築製, 構鏇鑰範鹽簾顧廠襯獵 ~ 蓋遞顧膚醖構糧網鑰構) 更多	-	2019-10-04
				Sodium chloride Sterile Injection 0.9% w/v (Placebo)	鹽糧艱選襯糧蓋鑰蓋餘(遞齋鑰廠鏇襯繭願鹽鏇) = 顧鹽製齋獵繭餘鏇憲網網簾簾衊鹹積壓糧築廠 (鹽鹹艱製築淵範襯築製, 網簾繭憲選蓋衊蓋鹽構 ~ 餘範鹹衊積衊醖遞繭鏇) 更多
NCT02667639 (ACR2017) 人工标引	临床1期	-	35	Rph-104	(夢製壓觸壓願積鏇繭積) = Totally 70 adverse events (AE) were reported, none of them were serious. 齋鹹製鑰遞選鏇鹹襯夢 (壓鹹簾廠構鑰網觸壓繭 )	积极	2017-09-18