Delving into the Latest Updates on Gletimbetasin with Synapse

Overview

Basic Info

Drug Type

Recombinant polypeptide

Synonyms

Recombinant human thymosin beta4, Recombinant human thymosin β4, Recombinant thymosin β4-NL005-1

+ [4]

Target

thymosin beta 4

Action

modulators

Mechanism

thymosin beta 4 modulators(Thymosin Beta-4 modulators), Actin modulators

Therapeutic Areas

Cardiovascular DiseasesOther DiseasesEye Diseases+ [1]

Active Indication

Acute myocardial infarctionST Elevation Myocardial InfarctionMyocardial Reperfusion Injury+ [4]

Inactive Indication-

Originator Organization

Beijing Northland Biotech.Co., Ltd.

Active Organization

Beijing Northland Biotech.Co., Ltd.

Biotoxtech Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 16480907

Source: *****

A multicenter randomized double-blind placebo parallel control design was used in this study. The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90 days after PCI.

Start Date15 Jul 2022

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

CTR20201682

/ CompletedPhase 2

注射用重组人胸腺素β4（NL005）用于急性心肌梗死患者的有效性和安全性研究

[Translation] Efficacy and safety of recombinant human thymosin β4 for injection (NL005) in patients with acute myocardial infarction

评价不同剂量注射用重组人胸腺素β4（NL005）用于急性心肌梗死患者的初步疗效及安全性。

[Translation]

To evaluate the preliminary efficacy and safety of different doses of recombinant human thymosin β4 for injection (NL005) in patients with acute myocardial infarction.

Start Date23 Nov 2020

Sponsor / Collaborator

Beijing Northland Biotech.Co., Ltd.

100 Clinical Results associated with Gletimbetasin

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100 Translational Medicine associated with Gletimbetasin

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100 Patents (Medical) associated with Gletimbetasin

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7

Literatures (Medical) associated with Gletimbetasin

01 Sep 2021·Journal of Cellular and Molecular MedicineQ2 · MEDICINE

A first‐in‐human, randomized, double‐blind, single‐ and multiple‐dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers

Q2 · MEDICINE

ArticleOA

Author: Wang, Yu ; Bai, Haihong ; Liu, Long ; Sun, Yinjian ; Lei, Chunpu ; Qi, Lu ; Liu, Jincan ; Han, Chengquan ; Li, Pu ; Liu, Chen ; Wang, Xinghe

AbstractThe study evaluated the safety, tolerability, pharmacokinetics (PK) and anti‐drug antibody (ADA) of the recombinant human thymosin β4 (NL005) for single and multiple intravenous injections in healthy subjects. Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days. The cohorts received ascending doses of either 0.05, 0.25, 0.5, 2.0, 5.0, 12.5 or 25.0 μg/kg in the single‐dose trial. A total of 30 healthy subjects were randomly enrolled in the multiple‐dose trial, and 3 cohorts (0.5, 2.0 and 5.0 μg/kg) were administered once human thymosin β4 daily for 10 days and observed for 28 days. The adverse events were mild to moderate in intensity. There were no dose‐limiting toxicities or serious adverse events. The plasma concentration, maximum peak concentration (Cmax) and AUC of each dose group increased with the increase in the dose. The tendency of terminal clearance in each dose group was consistent, and there was no obvious accumulation after continuous administration. Thus, the drug can be concluded to be well tolerated and safe in healthy people and suitable for use in a clinical study for the treatment of acute myocardial infarction.

21 Apr 2021·Mediators of InflammationQ3 · MEDICINE

Recombinant Human Thymosin Beta-4 Protects against Mouse Coronavirus Infection

Q3 · MEDICINE

ArticleOA

Author: Liu, Yanhong ; Yu, Rui ; Li, Ruihua ; Liu, Shuling ; Chen, Wei ; Chen, Zhengshan ; Xu, Junjie ; Fang, Ting ; Zhang, Yue ; Zhai, Yanfang ; Zhao, Mengsu ; Mao, Yunyun ; Li, Kai ; Gao, Yuemei

Coronaviruses (CoVs) are enveloped and harbor an unusually large (30–32 kb) positive-strand linear RNA genome. Highly pathogenic coronaviruses cause severe acute respiratory syndrome (SARS) (SARS-CoV and SARS-CoV-2) and Middle East respiratory syndrome (MERS) (MERS-CoV) in humans. The coronavirus mouse hepatitis virus (MHV) infects mice and serves as an ideal model of viral pathogenesis, mainly because experiments can be conducted using animal-biosafety level-2 (A-BSL2) containment. Human thymosin beta-4 (Tβ4), a 43-residue peptide with an acetylated N-terminus, is widely expressed in human tissues. Tβ4 regulates actin polymerization and functions as an anti-inflammatory molecule and an antioxidant as well as a promoter of wound healing and angiogenesis. These activities led us to test whether Tβ4 serves to treat coronavirus infections of humans. To test this possibility, here, we established a BALB/c mouse model of coronavirus infection using mouse CoV MHV-A59 to evaluate the potential protective effect of recombinant human Tβ4 (rhTβ4). Such a system can be employed under A-BSL2 containment instead of A-BSL3 that is required to study coronaviruses infectious for humans. We found that rhTβ4 significantly increased the survival rate of mice infected with MHV-A59 through inhibiting virus replication, balancing the host’s immune response, alleviating pathological damage, and promoting repair of the liver. These results will serve as the basis for further application of rhTβ4 to the treatment of human CoV diseases such as COVID-19.

01 May 2018·Archives of Insect Biochemistry and Physiology

Effects of overexpression and inhibited expression of thymosin, an actin‐interacting protein from Bombyx mori, on BmNPV proliferation and replication

Article

Author: Liao, Jinxu ; Zhang, Chen ; Zhang, Wenping ; Wang, Dan ; Ru, Wenjuan

AbstractPrevious study showed that exogenously applied recombinant thymosin from Bombyx mori (BmTHY) reduces B. mori nucleopolyhedrovirus (BmNPV) proliferation in silkworm. Which stands to reason that BmTHY in B. mori is crucial for the defense against BmNPV. However, little is known about the effect of endogenously overexpressed or repressed BmTHY on B. mori resistance to virus infection. To study this issue, we constructed an overexpression and inhibited expression systems of BmTHY in BmN cells. The viral titer and the analysis from the quantitative real‐time polymerase chain reaction (PCR) revealed that overexpression of BmTHY decreased the copies of BmNPV gene gp41, which goes over to inhibit the proliferation of BmNPV in BmN cells, while the inhibited expression of BmTHY significantly enhanced viral proliferation in infected BmN cells. These results indicated that endogenous BmTHY can inhibit BmNPV proliferation and replication in infected BmN cells. Furthermore, Co‐IP showed that BmTHY could bind to actin in BmN cells. Also, the overexpression or inhibited expression of BmTHY shifted the ratio of F/G‐actin in infected BmN cells. Lastly, the BmTHY, an actin‐interacting protein, might be one of the key host factors against BmNPV, which inhibits viral proliferation and replication in BmN cells.

100 Deals associated with Gletimbetasin

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 2	China	Beijing Northland Biotech.Co., Ltd.	15 Jul 2022
ST Elevation Myocardial Infarction	Phase 2	China	Beijing Northland Biotech.Co., Ltd.	23 Nov 2020
Myocardial Reperfusion Injury	Phase 2	China	Beijing Northland Biotech.Co., Ltd.	-
Myocardial Infarction	Phase 1	-	Biotoxtech Co., Ltd.	-
Acute Lung Injury	Preclinical	China	Beijing Northland Biotech.Co., Ltd.	24 Jul 2024
Respiratory Distress Syndrome, Adult	Preclinical	China	Beijing Northland Biotech.Co., Ltd.	24 Jul 2024
Xerophthalmia	Preclinical	China	Beijing Northland Biotech.Co., Ltd.	24 Jul 2024

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Biosimilar

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.

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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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Gletimbetasin

Overview

Basic Info

Structure/Sequence

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R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation