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Methods for treating il-6 mediated inflammation without immunosuppression

An IL-6, immunosuppressive technology, applied in immunoglobulins, chemical instruments and methods, medical preparations containing active ingredients, etc., can solve problems such as immunosuppression

Pending Publication Date: 2020-10-16
NOVO NORDISK AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although inhibition of IL-6 may be effective, treatment of chronic inflammation with IL-6 inhibitors using current dosage regimens often results in immunosuppression

Method used

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  • Methods for treating il-6 mediated inflammation without immunosuppression
  • Methods for treating il-6 mediated inflammation without immunosuppression
  • Methods for treating il-6 mediated inflammation without immunosuppression

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0347] 3.1 Example 1: Phase 1 / 2 Clinical Study

[0348] A Phase 1 / 2 clinical study was conducted to evaluate the safety, pharmacokinetics and pharmacodynamics of multiple IV doses of COR-001.

[0349] 3.1.1 Drug Products (COR-001)

[0350] COR-001 is a human IgG1, kappa antibody directed against interleukin-6 (IL-6). COR-001 contains a "YTE" mutation in its Fc region. The sequence and other characteristics of COR-001 are described in Section 2.7.1.1 above.

[0351] 3.1.2 Study design

[0352] This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics and pharmacokinetics of multiple doses of COR-001 (MEDI5117) or placebo administered to a sequential cohort of hemodialysis patients. Efficacy.

[0353] Key inclusion criteria included stage 5 chronic kidney disease (CKD-5) on hemodialysis, TMPRSS6 736A genotype (major allele) positivity, IL-6 levels above 4 pg / mL, and erythropoietic anti-inflammatory drugs above 8. s...

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Abstract

The disclosure provides methods of treating inflammation without inducing immune suppression. The method comprises administering a therapeutically effective amount of an IL-6 antagonist at a dose sufficient to reduce inflammation without causing immune suppression.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 62 / 614,134, filed January 5, 2018, which is hereby incorporated by reference in its entirety. [0003] sequence listing [0004] This application contains a Sequence Listing that has been submitted via EFS-Web and is hereby incorporated by reference in its entirety. Said ASCII copy, created on _____________, is named 38802US_sequence list.txt and is _____________ bytes in size. Background technique [0005] Chronic inflammation is a feature of many diseases, including classic rheumatic disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and inflammatory bowel disease, as well as others that are increasingly understood to be associated with chronic Inflammation-related systemic diseases such as cardiovascular disease, renal disease, neuroinflammatory disease, anemia, cancer and aging. [0006] The pro-inflammat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P29/00A61P19/02A61P13/12A61P9/04A61P9/10A61P7/06A61P3/10A61P1/16A61P19/10A61P25/24A61P11/06A61P25/16A61P25/28A61P25/00A61P27/02A61P35/00A61P17/00
CPCA61K2039/55C07K16/248A61P37/02C07K2317/76A61K2039/545A61P13/12A61K2039/505A61P19/02C07K2317/52A61P29/00
Inventor M·N·德瓦拉拉亚M·H·戴维森R·卡卡
Owner NOVO NORDISK AS
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