Application of optimized TACI (Transmembrane Activator and CAML Interactor)-Fc fusion protein in preparation of medicaments for treating rheumatoid arthritis

A fusion protein, rheumatoid technology, used in drug combinations, antipyretics, anti-inflammatory agents, etc., can solve problems such as easy protein degradation

Active Publication Date: 2011-06-08
REMEGEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] TACI was first discovered by scientists Von Bulow and Bram of St. Jude Children's Hospital, a famous academic institution in the United States, but later r

Method used

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  • Application of optimized TACI (Transmembrane Activator and CAML Interactor)-Fc fusion protein in preparation of medicaments for treating rheumatoid arthritis
  • Application of optimized TACI (Transmembrane Activator and CAML Interactor)-Fc fusion protein in preparation of medicaments for treating rheumatoid arthritis
  • Application of optimized TACI (Transmembrane Activator and CAML Interactor)-Fc fusion protein in preparation of medicaments for treating rheumatoid arthritis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1: The main pharmacodynamic study of RCT-18 on collagen-induced arthritis (CIA) in mice and adjuvant-induced arthritis (AA) in rats.

[0040] 1.1 Test method

[0041] ① Pharmacodynamic test method on CIA mice

[0042] On d0 and d21, DBA / 1 mice were intradermally injected with 100 μg type II collagen and complete Freund's adjuvant at multiple points on the base of the tail and back to induce the CIA mouse model, and were randomly divided into 8 groups, namely normal group, model group, RCT-18 Three dose groups (1, 3, 9mg / Kg, subcutaneous injection, once every two days, medication for 6 weeks), positive control group Yisaipu (rhTNFR:Fc, 4mg / Kg, subcutaneous injection, once every two days, medication for 6 weeks) ), methotrexate (MTX, 2mg / Kg, intragastric administration, once a week) group, and an IgG-Fc (9mg / Kg, subcutaneous injection, once every two days, medication for 6 weeks) negative control group. Normal group and model group were injected with normal sali...

Embodiment 2

[0068] Example 2: Pharmacokinetic study of RCT-18 in rats and rhesus monkeys

[0069] 2.1.1 Pharmacokinetic study in rats

[0070] This study established the RCT-18 in plasma 125 I isotope labeling tracer assay method, and application established method, studied rat intravenous injection (iv) 1mg / kg and subcutaneous injection (sc) three single-dose groups (1,4 and 16mg / kg) and multiple ( 5 times) After subcutaneously injecting a dose group (4mg / kg) of RCT-18 lyophilized injection, the time-dependent change curve of RCT-18 in plasma was analyzed by using DAS2.0 software, compartment model and statistical moment method respectively. academic analysis. Results: ①The CPM value of blank plasma was low and a stable value. The extraction recovery rate of RCT-18 in plasma is greater than 79%, the method recovery rate is greater than 99%, and the inter-assay and intra-assay coefficients of variation are both less than 10%. The linear range of RCT-18 was 0.1-20 μg / ml, and the correl...

Embodiment 3

[0083] Embodiment 3: RCT-18 animal safety evaluation study

[0084] In each test of non-clinical animal safety evaluation, RCT-18 showed good tolerance and safety in all test animals, and the test results are shown in Table 3.

[0085] Table 3 RCT-18 non-clinical safety test results

[0086]

[0087] In summary, the present invention provides an optimized TACI-Fc fusion protein for the preparation of the application of drugs for the treatment of rheumatoid arthritis, the drug of the present invention is safe and effective for the treatment of rheumatoid arthritis, and is beneficial to reduce The cost of this type of recombinant protein drug is suitable for industrial promotion and application.

[0088]

[0089]

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Abstract

The invention relates to the field of autoimmune disease treatment based on lymphocyte B-stimulated factor receptor-antibody fusion protein, in particular to application of optimized TACI (Transmembrane Activator and CAML Interactor)-Fc fusion protein in the preparation of medicaments for treating rheumatoid arthritis. The medicament provided by the invention can be safely and effectively used for treating rheumatoid arthritis, and is beneficial to lowering the cost of such recombinant protein medicaments, thereby being suitable for industrial popularization and application.

Description

technical field [0001] The present invention relates to the field of applying B lymphocyte stimulating factor receptor-antibody fusion protein to treat autoimmune diseases, more specifically, relates to the application of optimized TACI-Fc fusion protein in preparing medicine for treating rheumatoid arthritis. technical background [0002] Rheumatoid arthritis (RA) is a systemic autoimmune disease with high clinical incidence. Autoimmune diseases refer to immune diseases that are caused by the destruction of antibodies or sensitized lymphocytes produced by the body itself, damage to its own tissues and cellular components, resulting in tissue damage and organ dysfunction. It is divided into organ or cell-specific and systemic autoimmunity Two diseases. The pathological damage and dysfunction of the former are limited to a certain organ or a certain type of cells targeted by antibodies or sensitized lymphocytes; the autoantigens of the latter are common components of various...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P19/02A61P19/04A61P29/00
Inventor 房健民
Owner REMEGEN CO LTD
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