Delving into the Latest Updates on Recombinant human interleukin-1 receptor antagonist(General Regeneratives) with Synapse

Overview

Basic Info

Drug Type

Interleukins

Synonyms

+ [1]

Target

IL1R1

Mechanism

IL1R1 antagonists(Interleukin-1 receptor antagonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesCongenital Disorders+ [4]

Active Indication

Drug-induced diarrheaArthritis, GoutyColorectal Cancer

Inactive Indication

Toxicity due to chemotherapy

Originator Organization

General Regeneratives Shanghai Ltd.

Active Organization

General Regeneratives Shanghai Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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1. 评价UA007在痛风性关节炎急性发作患者中的有效性； 2. 评价UA007在痛风性关节炎急性发作患者中的安全性； 3. 评价UA007在痛风性关节炎急性发作患者中的群体药代动力学特征； 4. 评价UA007在痛风性关节炎急性发作患者中的免疫原性。

[Translation]

1. Evaluate the efficacy of UA007 in patients with acute gouty arthritis; 2. Evaluate the safety of UA007 in patients with acute gouty arthritis; 3. Evaluate the population pharmacokinetic characteristics of UA007 in patients with acute gouty arthritis; 4. Evaluate the immunogenicity of UA007 in patients with acute gouty arthritis.

Start Date18 Aug 2022

Sponsor / Collaborator

General Regeneratives Shanghai Ltd.

100 Clinical Results associated with Recombinant human interleukin-1 receptor antagonist(General Regeneratives)

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100 Translational Medicine associated with Recombinant human interleukin-1 receptor antagonist(General Regeneratives)

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100 Patents (Medical) associated with Recombinant human interleukin-1 receptor antagonist(General Regeneratives)

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6

Literatures (Medical) associated with Recombinant human interleukin-1 receptor antagonist(General Regeneratives)

01 Sep 2024·Nature Medicine

Anakinra in Sanfilippo syndrome: a phase 1/2 trial

Article

Author: Polgreen, Lynda E ; Luzzi, Anna ; O'Neill, Cara ; Iacovino, Michelina ; Morales Garval, Adolfo ; Pak, Youngju ; Chen, Agnes H ; Eisengart, Julie B ; Bitan, Gal ; Acevedo, Jonathan

AbstractSanfilippo syndrome is a fatal childhood neurodegenerative disorder involving neuroinflammation among multiple pathologies. We hypothesized that anakinra, a recombinant interleukin-1 receptor antagonist, could improve neurobehavioral and functional symptoms owing to its capacity to treat neuroinflammation. This phase 1/2 trial aimed to test the safety, tolerability and effects of anakinra on neurobehavioral, functional and quality-of-life outcomes in patients and their caregivers. The primary outcome was the percent of participants requiring a dose increase at week 8 or week 16. Secondary efficacy outcomes included a multi-domain responder index (MDRI). Twenty-three participants (6–26 years of age) were enrolled. Twenty continued treatment to week 8, and 15 (75%) required an increased dose at week 8 or week 16. There was an improvement in at least one domain in the MDRI in 18 of 21 (86%) at week 8 and in 15 of 16 (94%) at week 36. Seven participants withdrew (intolerability of daily injections and lost to follow-up) before week 36. Adverse events occurred in 22 of 23 (96%) participants, most commonly mild injection site reactions. No serious adverse events were related to anakinra. In conclusion, anakinra was safe and associated with improved neurobehavioral and functional outcomes, supporting continued investigation of anakinra in Sanfilippo syndrome and other mucopolysaccharidoses. ClinicalTrials.gov identifier: NCT04018755.

01 Oct 2019·European Journal of Drug Metabolism and PharmacokineticsQ4 · MEDICINE

Comment on: Pharmacokinetics and Safety of Recombinant Human Interleukin-1 Receptor Antagonist GR007 in Healthy Chinese Subjects

Q4 · MEDICINE

Letter

Author: Srinivas, Nuggehally R

This article describes about pharmacokinetics and safety of recombinant human interleukin-1 receptor antagonist GR007 in healthy chinese subjects.To investigate safety, tolerability, and pharmacokinetics of GR007 in healthy Chinese subjects following i.m. administration of GR007 at a single dose of either 30, 90, or 150 mg in a rising single-dose escalation study.Visual examination of the mean serum concentration vs. time profile suggested that for GR007 doses of 30 and 90 mg, the plateau in the profile appeared to last for between 1 and 4 h, while for the top dose of 150 mg of GR007, the plateau in the profle lasted at least another hour in healthy Chinese subjects.The author concluded higher dose of GR007 (150 mg) may have resulted in drug precipitation in the muscular tissue, which over time would be expected to slowly dissolve and to be released into systemic circulation, as seen in the serum profle in healthy Chinese subjects.

01 Jun 2019·European Journal of Drug Metabolism and Pharmacokinetics

Pharmacokinetics and Safety of Recombinant Human Interleukin-1 Receptor Antagonist GR007 in Healthy Chinese Subjects

Article

Author: Han, Wei ; Cui, Yimin ; Xie, Ran ; Zhou, Shuang ; Zhao, Xia ; Wang, Xin ; Zhao, Nan ; Zhang, Yang ; Yu, Yan

BACKGROUND AND OBJECTIVESThe recombinant human interleukin-1 receptor antagonist (rhIL-1Ra) GR007 is a candidate drug with the potential to prevent the toxicity induced by chemotherapy agents by blocking the IL-1 signaling pathway. The aim of this study was to assess the pharmacokinetics and safety of GR007 in healthy Chinese subjects.METHODSThirty subjects received a single intramuscular injection of 30 mg (n = 10), 90 mg (n = 10), or 150 mg (n = 10) GR007. After administration, the pharmacokinetic characteristics and safety were evaluated.RESULTSNo serious adverse events were reported in this study, and the adverse events reported showed no dose dependency. Pharmacokinetic analysis showed that the median time to maximum concentration (T_max) of GR007 in the three groups was between 2.75 and 4.00 h and the geometric mean elimination half-life (T_1/2) for each group was 2.38, 2.22, and 3.29 h, respectively. The area under the concentration vs time curve (AUC), but not the maximum concentration (C_max), increased in a dose-proportional manner.CONCLUSIONSThe results showed that a single intramuscular injection of 30-150 mg GR007 had good safety and tolerability in healthy Chinese subjects. The results of the evaluation of the safety and pharmacokinetics of GR007 performed in this study support its use as a repeated daily injection in ongoing clinical trials focusing on patients with cancer.

100 Deals associated with Recombinant human interleukin-1 receptor antagonist(General Regeneratives)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Drug-induced diarrhea	Phase 2	CN	General Regeneratives Shanghai Ltd.	29 Sep 2022
Arthritis, Gouty	Phase 2	CN	General Regeneratives Shanghai Ltd.	18 Aug 2022
Colorectal Cancer	Phase 2	CN	General Regeneratives Shanghai Ltd.	24 Jun 2019
Toxicity due to chemotherapy	Preclinical	CN	General Regeneratives Shanghai Ltd.	17 Apr 2017