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Methods of Treating Crohn's Disease with Anti-IL23 Specific Antibody

a technology of specific antibodies and crohn's disease, which is applied in the field of methods for treating crohn's disease with antibodies, can solve the problems of affecting the response of a large percentage of the target patient population, or losing the response over tim

Inactive Publication Date: 2019-09-05
JANSSEN BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a method for treating Crohn's disease using an anti-IL-23 specific antibody, such as guselkumab, which is administered to patients in an initial intravenous induction dose, followed by subcutaneous treatment every 4 or 8 weeks. The method has shown promising results in improving clinical endpoints in patients with Crohn's disease, including reducing disease activity, achieving clinical remission, and inducing durable clinical remission. The patent also describes a pharmaceutical composition containing the anti-IL-23 specific antibody in a specific formulation.

Problems solved by technology

Although the introduction of biologic agents has significantly improved the clinical management of patients with moderately to severely active Crohn's disease, a sizable proportion of the target patient population is non-responsive or will lose response over time.

Method used

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Preclinical Evidence Implicating IL-23 as a Target in Crohn's Disease

[0195]Genetic and animal model studies have explored the contribution of IL-12 and IL-23 in driving the pathophysiology of Crohn's disease. The results indicate that IL-23 plays a predominant role in inflammatory bowel disease (IBD) and emerging evidence suggests that blocking IL-23 alone may be a more effective strategy than blocking both IL-12 and IL-23.

[0196]Initial observations from genetic and animal model data suggest that Crohn's disease is mediated by IL-12 and / or IL-23, potentially through the Th1 and Th17 pathways they induce, respectively. However, increasing evidence suggests a predominant role for IL-23 in Crohn's disease. Genome-wide association studies identified polymorphisms in the IL-23R gene that are associated with Crohn's disease. The role of IL-23 in driving intestinal inflammation has been shown in several mouse models. Mice treated with anti-IL-23 antibodies exhibited attenuated inflammation...

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Abstract

A method of treating Crohn's disease in a patient administers an IL-23 specific antibody, e.g., guselkumab, at an initial intravenous dose and subsequence subcutaneous doses.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to United States Provisional Application Ser. No. 62 / 638,624, filed 5 Mar. 2018. The entire contents of the aforementioned application are incorporated herein by reference in their entireties.SEQUENCE LISTING[0002]The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on 1 Mar. 2019 is named JBI5153USNP1SEQLIST.txt and is 79,744 bytes in size.FIELD OF THE INVENTION[0003]The present invention concerns methods for treating Crohn's Disease with an antibody that binds the human IL-23 protein. In particular, it relates to dosing regimens for administration of an anti-IL-23 specific antibody and specific pharmaceutical compositions of an antibody, e.g., guselkumab.BACKGROUND OF THE INVENTION[0004]Interleukin (IL)-12 is a secreted heterodimeric cytokine comprised of 2 disulfide-li...

Claims

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Application Information

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IPC IPC(8): A61K38/17C07K16/24A61P1/00A61P37/06
CPCA61K38/1793C07K16/244A61P1/00A61K2039/57A61K2039/545A61K2039/505C07K2317/76A61P37/06A61K38/17A61K9/08A61K47/26A61K47/22A61K2039/54C07K2317/565
Inventor ADEDOKUN, OMONIYICHAN, DAPHNECHEN, YANGSZAPARY, PHILIPPE
Owner JANSSEN BIOTECH INC
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