Delving into the Latest Updates on Promenakin with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

EFLEPEDOCOKIN ALFA, IL-22 IgG2 Fusion Protein, IL-22 fusion protein

+ [7]

Target

IL-22R

Action

antagonists

Mechanism

IL-22R antagonists(Interleukin-22 receptor antagonists)

Therapeutic Areas

Immune System DiseasesDigestive System DisordersOther Diseases

Active Indication

Hepatitis, AlcoholicAcute-On-Chronic Liver FailureAcute Graft Versus Host Disease+ [1]

Inactive Indication

COVID-19Pancreatitis

Originator Organization

Evive Biotech

Active Organization

Evive Biotech Co. Ltd.

Yifan Pharmaceutical Co., Ltd.

Inactive Organization

Evive Biotech

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 180975

Source: *****

This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia. The primary objective of this study is to evaluate the overall safety of F-652 in COVID subjects in order to identify safe dose(s) for future studies with adequate patient numbers to demonstrate clinical efficacy.

Start Date08 Apr 2022

Sponsor / Collaborator

Evive Biotech Co. Ltd.

CTR20212657

/ RecruitingPhase 2

评价注射用重组人白介素22-Fc融合蛋白（F-652）联合常规方案治疗慢加急性肝衰竭（ACLF）安全性和有效性的多中心、随机、双盲、安慰剂对照、两阶段的II期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled, two-stage Phase II clinical study to evaluate the safety and efficacy of recombinant human interleukin-22-Fc fusion protein for injection (F-652) combined with conventional regimen in the treatment of acute-on-chronic liver failure (ACLF)

1.主要目的阶段A：初步评价F-652 在ACLF患者中的安全性。阶段B：进一步评价 F-652在ACLF患者中的安全性和有效性。 2.次要目的阶段A：评价F-652在ACLF患者中的药代动力学（PK）特性。评价F-652对相关药效学（PD）生物标志物的影响。

[Translation]

1. Primary Objectives Phase A: Preliminary evaluation of the safety of F-652 in ACLF patients. Phase B: Further evaluation of the safety and efficacy of F-652 in ACLF patients. 2. Secondary Objectives Phase A: Evaluate the pharmacokinetic (PK) properties of F-652 in ACLF patients. Evaluate the effect of F-652 on relevant pharmacodynamic (PD) biomarkers.

Start Date25 Nov 2021

Sponsor / Collaborator

Evive Biotech Co. Ltd.

NCT04498377

/ TerminatedPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19

This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a COVID-19 diagnosis confirmed by PCR. Eligible patients will have moderate to severe COVID-19 symptoms within 5 days post hospitalization and a positive COVID-19 testing.

Start Date26 Jan 2021

Sponsor / Collaborator

Evive Biotech

100 Clinical Results associated with Promenakin

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100 Translational Medicine associated with Promenakin

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100 Patents (Medical) associated with Promenakin

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136

Literatures (Medical) associated with Promenakin

01 Nov 2024·Clinics in Liver Disease

Emerging Pharmacologic Treatments for Alcohol-Associated Hepatitis

Review

Author: Morgan, Timothy R ; Morgan, Timothy R.

Several treatments have shown efficacy in preliminary alcohol-associated hepatitis trials. Interleukin-22 improved Model of End-stage Liver Disease score and aminotransferases in a phase II trial. The endogenous cholesterol derivative, larsucosterol, improved outcomes in a multi-center United States or European phase II trial. The antioxidants N-acetylcysteine and metadoxine improved survival in large trials. Trials from India report improved survival with granulocyte-colony stimulating factor, as well as improved outcome among patients receiving fecal microbiota transfer. Translational studies suggest that phage treatment of cytolytic Enterococcus faecalis may reduce liver injury.

01 Oct 2024·Journal of Interferon & Cytokine Research

Interleukin-22 Promotes Cell Proliferation to Combat Virus Infection in Human Intestinal Epithelial Cells

Article

Author: Boulant, Steeve ; Guzmán, José ; Herrmann, Carl ; Stanifer, Megan L. ; Guo, Cuncai ; Sharma, Ashwini Kumar

Interferon lambdas (IFN-λs) are crucial to control virus infections at mucosal surfaces. Interleukin-22 (IL-22) was reported to help IFN-λ control rotavirus infection in the intestinal epithelium of mice either by aiding in the induction of interferon-stimulated genes (ISGs) or by increasing cell proliferation thereby clearing virally infected cells. We investigated whether IL-22 and IFN-λs exhibit similar synergistic effects in human intestinal epithelial cells (IECs) models. Our results showed that co-treatment of IL-22 and IFN-λ induced more phosphorylation of STAT1 than either cytokine used alone. However, this increased STAT1 activation did not translate to increased ISGs production or antiviral protection. Transcriptomics analysis revealed that despite sharing a common subunit (IL-10Rb) within their heterodimeric receptors and activating similar STATs, the signaling generated by IL-22 and IFN-λs is independent, with IFN-λ signaling inducing ISGs and IL-22 signaling inducing cell proliferation genes. Using human intestinal organoids, we confirmed that IL-22 increased the size of the organoids through increased cell proliferation and expression of the stem cell marker (OLFM4). These findings suggest that in human intestinal cells, IFN-λs and IL-22 act independently to clear virus infections. IFN-λs induce ISGs to control virus replication and spread, whereas IL-22 increases cell proliferation to eliminate infected cells and repair the damage epithelium. Although these two cytokines do not act synergistically, each plays a key function in the protection of human IECs.

01 Oct 2024·Clinical and Molecular Hepatology

Immunological mechanisms in steatotic liver diseases: An overview and clinical perspectives

Review

Author: Gao, Wenyuan ; Yan, Mengyao ; Ma, Long ; Huang, Luqi ; Guo, Lanping ; Man, Shuli

Steatotic liver diseases (SLD) are the principal worldwide cause of cirrhosis and end-stage liver cancer, affecting nearly a quarter of the global population. SLD includes metabolic dysfunction-associated alcoholic liver disease (MetALD) and metabolic dysfunction-associated steatotic liver disease (MASLD), resulting in asymptomatic liver steatosis, fibrosis, cirrhosis and associated complications. The immune processes include gut dysbiosis, adiposeliver organ crosstalk, hepatocyte death and immune cell-mediated inflammatory processes. Notably, various immune cells such as B cells, plasma cells, dendritic cells, conventional CD4<sup>+</sup> and CD8<sup>+</sup> T cells, innate-like T cells, platelets, neutrophils and macrophages play vital roles in the development of MetALD and MASLD. Immunological modulations targeting hepatocyte death, inflammatory reactions and gut microbiome include N-acetylcysteine, selonsertib, F-652, prednisone, pentoxifylline, anakinra, JKB-121, HA35, obeticholic acid, probiotics, prebiotics, antibiotics and fecal microbiota transplantation. Understanding the immunological mechanisms underlying SLD is crucial for advancing clinical therapeutic strategies.

100 Deals associated with Promenakin

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16366

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis, Alcoholic	Phase 2	United States	Yifan Pharmaceutical Co., Ltd.	13 Jul 2022
Acute-On-Chronic Liver Failure	Phase 2	China	Evive Biotech Co. Ltd.	25 Nov 2021
Acute Graft Versus Host Disease	Phase 2	United States	Evive Biotech Co. Ltd.	-
COVID-19	Preclinical	United States	Evive Biotech	26 Jan 2021
Enterocolitis, Necrotizing	Preclinical	United States	Evive Biotech Co. Ltd.	-
Pancreatitis	Discovery	China	Evive Biotech Co. Ltd.	05 Apr 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2024 Manual	Phase 2	Acute Graft Versus Host Disease	3	F-652 (rhIL-22 fusion protein)	(dfazvvdtoe) = F-652 treatment was well tolerated without significant drug-related adverse events wnkwltjzpo (quskarslix ) View more	Positive	01 Feb 2024
NCT04498377 (CTgov)	Phase 2	COVID-19	1	F-652 (F-652)	amshjjatwm(qjktgnnska) = scxepqryud froyyxeqqk (vqcltrqgjq, jhwxiwnfvj - qjrtdupogq) View more	-	21 Dec 2023
NCT04498377 (CTgov)	Phase 2	COVID-19	1	Placebo (Placebo)	amshjjatwm(qjktgnnska) = zuedovdaez froyyxeqqk (vqcltrqgjq, lbvhisftzr - xawfhidxba) View more	-	21 Dec 2023
NCT02406651 (Pubmed)	Phase 2	Acute Graft Versus Host Disease	27	Interleukin-22 and systemic corticosteroids	lwogwoavzc(ihprwndqtt) = qvzmkmtewb azqcoxzxcf (xfjvutovtb, 56 - 79)	-	18 Nov 2022
NCT02406651 (Phase 2 Study of F-652, CTgov)	Phase 1/2	Acute Graft Versus Host Disease	30	Systemic Corticosteroids+Recombinant Human Interleukin-22 IgG2-Fc (F-652)	fcreturkhh(cmhlveglum) = wzobkrgier xobuzjrmxz (yiuyvvjunv, ieuqecbacg - pbynqkjwos) View more	-	22 Jul 2021
NCT02406651 (Phase 2 Study of F-652, EBMT2020)	Phase 2	Graft vs Host Disease	27	F-652	(sixzolufzw) = nptoutsvtz wfmorgcfog (muzbkmjozg, 56 - 79) View more	Positive	29 Aug 2020
Tandem Meetings ASTCT and CIBMTR2020	Phase 2	Acute Graft Versus Host Disease	27	F-652	llsgqazxfq(xafeczuaqm) = ngfdzjftih iqhxqflwsk (syguralpqt, 56 - 79) View more	Positive	01 Mar 2020
NCT02655510 (TREAT 008, CTgov)	Phase 1/2	Hepatitis, Alcoholic	18	F-652 (Period 1: F-652 10 μg/kg)	okxyiunrbn(rbnsnhmiun) = fkzvljadpp vevmrdhyzb (zhzftruuqb, ehliuijjte - qzmncviwol) View more	-	09 Sep 2019
NCT02655510 (TREAT 008, CTgov)	Phase 1/2	Hepatitis, Alcoholic	18	F-652 (Period 2: F-652 30 μg/kg)	okxyiunrbn(rbnsnhmiun) = whvkdzigsa vevmrdhyzb (zhzftruuqb, vpujyadset - bpdsudkfax) View more	-	09 Sep 2019

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Promenakin

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation