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Methods for treating systemic sclerosis

A systemic sclerosis, specific technology used in the field of bispecific anti-IL-4-anti-IL-13 antibodies

Pending Publication Date: 2022-01-04
SANOFI SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, finding effective targeted therapies with a limited side effect profile for this disease population is an unmet need

Method used

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  • Methods for treating systemic sclerosis
  • Methods for treating systemic sclerosis
  • Methods for treating systemic sclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0235] Example 1: Efficacy and safety of the humanized anti-IL-4 / IL-13 bispecific antibody RKB in the treatment of subjects with diffuse systemic sclerosis.

[0236] The efficacy of RKB compared to placebo was evaluated in a phase 2 study (NCT02921971) on cutaneous fibrosis in subjects with diffuse systemic sclerosis (dcSSc) when administered subcutaneously for 24 weeks.

[0237] method

[0238] A multinational, randomized, double-blind, placebo-controlled, 2 parallel-group proof-of-concept phase 2 study investigating the efficacy of RKB 200 mg administered subcutaneously once weekly over a 24-week period in subjects with diffuse SSc and security. Approximately 94 patients were randomized 1:1 to the following two treatment groups: 1) the RKB group (N=47), which received 200 mg of RKB given subcutaneously every week; and 2) the placebo group (N=47), which Placebo administered subcutaneously was received weekly. Randomization will be stratified based on the patient's history...

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PUM

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Abstract

The invention provides methods for treating systemic sclerosis by administering a dual-V region bispecific antibody that specifically binds IL-4 and IL-13.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application No. 62 / 852,941, filed May 24, 2019, European Patent Application No. EP19306309.6, filed October 8, 2019, and U.S. Provisional Application No. 62 / 979,875, each of which is incorporated herein by reference in its entirety. [0003] Submission of sequence listings in ASCII text files [0004] The contents of the following submitted ASCII text file are hereby incorporated by reference in their entirety: Computer Readable Form of the Sequence Listing (CRF) (File Name: 183952031841SEQLIST.TXT, Date of Record: May 21, 2020, Size: 16KB) . technical field [0005] The present invention relates to bispecific anti-IL-4-anti-IL-13 antibodies for the treatment of systemic sclerosis (also known as scleroderma). Background technique [0006] Systemic sclerosis (also known as scleroderma) is a chronic, disabling condition characterized by three key features: immune dysregulation...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P17/00
CPCC07K16/244C07K16/247A61P17/00A61K2039/505A61K2039/545A61K2039/54C07K2317/31C07K2317/33C07K2317/76A61P11/00A61K47/02A61K47/18A61K47/26A61K47/183A61K9/19A61P37/00A61P25/28A61K9/0019A61K45/06C07K2317/565
Inventor P·王C·苏布拉纳C·埃斯普雷F·马拉切
Owner SANOFI SA
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