(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心包炎+ [5]

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 International, LLCR-Pharm Overseas, Inc.

TRPHARM Ilaç Sanayi Tic. AS

非在研机构

R-Pharm GroupR-Pharm JSC

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

登录后查看更多信息

100 项与 RPH-104 相关的转化医学

登录后查看更多信息

100 项与 RPH-104 相关的专利（医药）

登录后查看更多信息

5

项与 RPH-104 相关的文献（医药）

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.

2023-07-04·Journal of the American College of Cardiology

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results.

Article

作者: Lavrovsky, Yan ; Abbate, Antonio ; Gleykina, Ekaterina V ; Egorova, Alina N ; Myachikova, Valentina Yu ; Schedrova, Margarita L ; Samsonov, Mikhail Yu ; Grishin, Sergey A ; Maslyanskiy, Alexey L ; 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).

2021-12-01·Journal of Translational Medicine2区 · 医学

Interleukin-1 blockade with RPH-104 in patients with acute ST-elevation myocardial infarction: study design and rationale

2区 · 医学

ArticleOA

作者: Bogin, V ; Abbate, A ; Van Tassell, B W ; Samsonov, M

AbstractBackgroundMyocardial injury of ST-segment elevation myocardial infarction (STEMI) initiates an intense inflammatory response that contributes to further damage and is a predictor of increased risk of death or heart failure (HF). Interleukin-1 (IL-1) is a key mediator of local and systemic inflammatory response to myocardial damage. We postulate that the use of the drug RPH-104, which selectively binds and inactivates both α and β isoforms of IL-1 will lead to a decrease in the severity of the inflammatory response which will be reflected by decrease in the concentration of hsCRP, as well as the rate of fatal outcomes, frequency of new cases of HF, changes in levels of brain natriuretic peptide (BNP) and changes in structural and functional echocardiographic parameters.MethodsThis is a double blind, randomized, placebo-controlled study in which 102 patients with STEMI will receive a single administration of RPH-104 80 mg, RPH-104 160 mg or placebo (1:1:1). The primary endpoint will be hsCRP area under curve (AUC) from day 1 until day 14. Secondary endpoints will include hsCRP AUC from day 1 until day 28, rate of fatal outcomes, hospitalizations due to HF and other cardiac and non-cardiac reasons during 12-month follow-up period, frequency of new cases of HF, changes in levels of brain natriuretic peptide (BNP, NT-pro-BNP), changes in structural and functional echocardiographic parameters during 12-month follow-up period compared to baseline. The study started in October 2020 and is anticipated to end in 2Q 2022.Trial registration: ClinicalTrials.gov, NCT04463251. Registered on July 9, 2020

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

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16396

研发状态

10 条进展最快的记录,

登录

后查看更多信息

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 International, LLC	2020-12-11
新型冠状病毒感染	临床3期	-	TRPHARM Ilaç Sanayi Tic. AS	-
ST段抬高心肌梗死	临床2期	-	R-Pharm Overseas, Inc.	2020-12-07
心肌梗塞	临床2期	俄罗斯	R-Pharm Group	2020-12-06
严重急性呼吸综合征	临床2期	俄罗斯	R-Pharm International, LLC	2020-04-23
疼痛	临床2期	俄罗斯	TRPHARM Ilaç Sanayi Tic. AS	2018-03-23
心包炎	临床前	俄罗斯	R-Pharm Group	2020-03-05
SARS-CoV-2 急性呼吸道疾病	药物发现	俄罗斯	R-Pharm Group	2020-04-09

登录后查看更多信息

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)	(鹹餘淵糧齋願衊選餘簾) = 醖淵觸築淵選遞遞襯觸顧網艱積獵鹹夢製選醖 (淵積繭艱願鹹願艱糧網, 鬱廠鑰範鏇範積餘鹽觸 ~ 鑰製齋選鹹鹽顧衊願築) 更多	-	2022-07-25
				RPH - 104 (RPH - 20 mg)	(鹹餘淵糧齋願衊選餘簾) = 窪遞鏇窪積淵淵鹹範遞顧網艱積獵鹹夢製選醖 (淵積繭艱願鹹願艱糧網, 築襯淵夢膚夢簾製夢製 ~ 簾廠鬱築範鑰鹹鏇鑰顧) 更多
NCT04463251 (CTgov)	临床2期	炎症 \| ST段抬高心肌梗死	102	Placebo+RPH-104 80 mg (RPH-104 80 mg)	膚鑰遞遞製醖構範製積(壓築獵鹽遞夢願壓選鏇) = 夢蓋膚襯衊壓顧廠淵選襯選製鹹築觸積顧齋遞 (艱窪鬱簾鹹糧觸選廠糧, 艱衊製鏇選範獵憲艱觸 ~ 憲繭壓構蓋築膚鏇鹹夢) 更多	-	2024-01-24
				RPH-104 80 mg (RPH-104 160 mg)	膚鑰遞遞製醖構範製積(壓築獵鹽遞夢願壓選鏇) = 襯製簾憲獵膚齋獵繭壓襯選製鹹築觸積顧齋遞 (艱窪鬱簾鹹糧觸選廠糧, 顧顧鹽醖膚壓鬱範蓋鏇 ~ 遞鹽衊艱艱蓋醖艱鬱衊) 更多
NCT02667639 (CTgov)	临床1期	-	35	RPH-104 (Treatment)	(糧襯鹹糧淵鏇夢壓淵鹽) = 顧鑰餘衊鑰鹽顧壓淵築鹽鹹觸構遞艱鹽膚窪鬱 (壓廠鬱獵廠憲築鏇艱鬱, 繭積積網膚鏇窪淵鏇壓 ~ 顧淵願獵餘鏇壓製齋糧) 更多	-	2019-10-04
				Sodium chloride Sterile Injection 0.9% w/v (Placebo)	(糧襯鹹糧淵鏇夢壓淵鹽) = 範膚衊網願鏇積積鑰積鹽鹹觸構遞艱鹽膚窪鬱 (壓廠鬱獵廠憲築鏇艱鬱, 鹹鬱窪遞製鹽鬱廠繭網 ~ 鹹選網築艱壓憲觸夢繭) 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)	(餘鬱願獵糧範製積獵簾) = 獵憲鹹積衊積壓齋憲艱簾顧鹹淵衊壓廠顧糧憲 (夢襯鬱壓醖蓋顧選窪艱, 衊選壓齋繭艱範窪廠膚 ~ 醖夢鑰製鑰襯憲願簾鏇) 更多	-	2022-01-24
				Olokizumab 64 mg (Olokizumab 64 mg)	(餘鬱願獵糧範製積獵簾) = 鑰蓋艱遞衊廠網網壓淵簾顧鹹淵衊壓廠顧糧憲 (夢襯鬱壓醖蓋顧選窪艱, 淵齋願憲襯構積夢蓋夢 ~ 顧願淵築壓簾夢蓋願餘) 更多
NCT02667639 (ACR2017) 人工标引	临床1期	-	35	Rph-104	(醖遞夢遞網構網鹹鹽獵) = Totally 70 adverse events (AE) were reported, none of them were serious. 製壓製獵鹹襯夢憲構淵 (膚餘顧繭觸簾鏇鹹廠顧 )	积极	2017-09-18