Delving into the Latest Updates on Goflikicept with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Target

IL-1β

Mechanism

IL-1β inhibitors(Interleukin-1 beta inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases+ [5]

Active Indication

Idiopathic Recurrent PericarditisCOVID-19Pericarditis+ [4]

Inactive Indication

InflammationPainPrimary gout+ [4]

Originator Organization

R-Pharm JSC

Active Organization

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

+ [1]

Inactive Organization

R-Pharm Group

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Gene Sequence

Sequence Code 9964977

Source: *****

Sequence Code 774056835

Source: *****

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.

Start Date01 Dec 2023

Sponsor / Collaborator

R-Pharm International, LLC

[+1]

NCT05107934 / Not yet recruitingPhase 2/3

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.

Start Date01 Dec 2023

Sponsor / Collaborator

R-Pharm Overseas, Inc.

[+2]

NCT04213274 / Not yet recruitingPhase 2

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

Start Date01 May 2023

Sponsor / Collaborator

R-Pharm Overseas, Inc.

[+1]

100 Clinical Results associated with Goflikicept

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100 Translational Medicine associated with Goflikicept

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100 Patents (Medical) associated with Goflikicept

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8

Literatures (Medical) associated with Goflikicept

01 Aug 2024·JACC: Cardiovascular Imaging

Pericardial Diseases

Review

Author: Luis, Sushil Allen ; Kwon, Deborah H ; Tan, Carmela D ; Brucato, Antonio ; Rodriugez, E Rene ; Hoit, Brian ; Lin, David ; Mardigyan, Vartan ; Weber, Brittany ; Imazio, Massimo ; 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.

01 Sep 2023·Current cardiology reports

Paradigm Shift in Diagnosis and Targeted Therapy in Recurrent Pericarditis.

Review

Author: 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.

01 Jul 2023·Journal of the American College of Cardiology

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept

Article

Author: 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

News (Medical) associated with Goflikicept

21 Jan 2021

·www.biospace.com

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 Deals associated with Goflikicept

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16396

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Recurrent Pericarditis	Phase 3	RU	R-Pharm JSC	11 Dec 2020
Idiopathic Recurrent Pericarditis	Phase 3	RU	R-Pharm International, LLC	11 Dec 2020
COVID-19	Phase 3	-	TRPHARM Ilaç Sanayi Tic. AS	-
Myocardial Infarction	Phase 1	RU	R-Pharm Group	06 Dec 2020
Pain	Phase 1	RU	TRPHARM Ilaç Sanayi Tic. AS	23 Mar 2018
Pericarditis	IND Application	RU	R-Pharm Group	05 Mar 2020
Still's Disease, Adult-Onset	Preclinical	RU	R-Pharm International, LLC	01 Dec 2023
Severe Acute Respiratory Syndrome	Preclinical	RU	R-Pharm International, LLC	23 Apr 2020
SARS-CoV-2 acute respiratory disease	Preclinical	RU	R-Pharm Group	09 Apr 2020
Primary gout	Preclinical	RU	R-Pharm JSC	26 Mar 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04067492 (CTgov)	Phase 2	Primary gout	47	RPH - 104 (RPH - 4 mg)	ondagbofwh(dvtrzzmvaz) = fqhxsxjrit ovkqvieejt (tlvmplufni, qyxoclpwog - getprrvxbd) View more	-	25 Jul 2022
				RPH - 104 (RPH - 20 mg)	ondagbofwh(dvtrzzmvaz) = swxitszpnp ovkqvieejt (tlvmplufni, jsauaoatxd - bfojozhtzw) View more
NCT04380519 (CTgov)	Phase 2/3	COVID-19 \| Severe Acute Respiratory Syndrome	372	RPH-104 80 mg (RPH -104 80 mg)	zmdgqnrnqf(kzzthbkpom) = aglgydynak siwyycdmah (ddeqdnxrou, qvjaylsdmp - wnnnxvvzmk) View more	-	24 Jan 2022
				Olokizumab 64 mg (Olokizumab 64 mg)	zmdgqnrnqf(kzzthbkpom) = cazioyuyvn siwyycdmah (ddeqdnxrou, ghpxnuifdm - sulqfbzyav) View more
NCT02667639 (CTgov)	Phase 1	-	35	RPH-104 (Treatment)	(ipjbjqikem) = zclmvhcvwf nubghbvmli (adknuknqsi, lbyoiwfoij - jgxvhesczm) View more	-	04 Oct 2019
				Sodium chloride Sterile Injection 0.9% w/v (Placebo)	(ipjbjqikem) = kltytxelsx nubghbvmli (adknuknqsi, gbnqxgcgqe - uzxxkebvxi) View more