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Method of treating c3 glomerulopathy

Inactive Publication Date: 2017-07-20
CHEMOCENTRYX INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present disclosure is about a method of treating a human who is suffering from or susceptible to C3 glomerulopathy by administering an effective amount of a C5aR antagonist. The C5aR antagonist is a compound that can inhibit the action of a protein called C5a, which is involved in the inflammation process. The compound has a specific formula and can be administered in various ways, such as through injection or orally. The technical effect of the patent is to provide a new treatment option for C3 glomerulopathy, which is a chronic kidney disease that affects a person's kidneys and can lead to kidney failure.

Problems solved by technology

Without treatment, C3G invariably leads to kidney failure, and kidney transplant is frequently the only option.
Even after transplantation, the new kidney will frequently fail due to recurrence of the disease.

Method used

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  • Method of treating c3 glomerulopathy
  • Method of treating c3 glomerulopathy
  • Method of treating c3 glomerulopathy

Examples

Experimental program
Comparison scheme
Effect test

embodiments

[0039]The present disclosure is directed to a method of treating a human suffering from or susceptible to complement 3 glomerulopathy comprising administering to the human an effective amount of a compound having the formula (I), or a pharmaceutically acceptable salt thereof,

wherein[0040]C1 is phenyl optionally substituted with from 1 to 3 R1 substituents;[0041]C2 is phenyl optionally substituted with from 1 to 3 R2 substituents;[0042]C3 is selected from the group consisting of C3-8 cycloalkyl and phenyl, and each C3 is optionally substituted with from 1-3 R3 substituents;[0043]each R1 is independently selected from the group consisting of[0044]halogen, —CN, —Rc, —CO2Ra, —CONRaRb, —C(O)Ra, —OC(O)NRaRb, —NRbC(O)Ra, —NRbC(O)2Rc, —NRaC(O)NRaRb, —NRaRb, —ORa, and —S(O)2NRaRb; wherein each Ra and Rb is independently selected from hydrogen, C1-8 alkyl, and C1-8 haloalkyl, or when attached to the same nitrogen atom can be combined with the nitrogen atom to form a five or six-membered ring ...

example 1

Compound 1 in a Patient with Progressive Complement 3 Glomerulonephritis

[0216]Under the Special Needs program in the United Kingdom (which is similar to a compassionate use protocol in the US), a C3 glomerulonephritis patient received treatment with the orally administered complement inhibitor compound 1, following the protocol detailed below. The patient had refractory disease despite a kidney transplant and prior treatment with the broadly immunosuppressive drugs rituximab, cyclophosphamide, mycophenolate mofetil, tacrolimus, and steroids. Renal allograft biopsies were taken pre-dose, 2 and 7 months during therapy.

Results:

[0217]The patient's condition improved in response to compound 1 treatment. The improvement seen with compound 1 treatment in this patient was based on the on-treatment kidney biopsy histologic findings that showed clearance ofglomerular endocapillary proliferation and a marked decrease in glomerular inflammatory macrophages compared to the pre-treatment biopsy. ...

example 2

zed, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Compound 1 in Patients with C3 Glomerulopathy

Protocol of the Study Planned

Aim

[0278]The aim of this study is to evaluate the effect of compound 1 treatment on renal disease activity in patients with complement 3 glomerulopathy (C3G). The intent is to slow down or improve renal disease with compound 1 treatment in these patients.

Objectives

[0279]The primary objective is to evaluate the efficacy of compound 1 compared to placebo based on histologic changes in C3G pathology from kidney biopsies taken before and during treatment.

[0280]The secondary objectives of this study include assessment of:[0281]1. The safety of compound 1 compared to placebo based on the incidence of adverse events, changes in clinical laboratory measurements, and vital signs;[0282]2. Changes in laboratory parameters of renal disease including estimated glomerular filtration rate (eGFR), proteinuria, and urinary excretion of m...

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Abstract

Methods of treating a human suffering from or susceptible to C3 glomerulopathy comprising administering to the human an effective amount of a C5aR antagonist are provided.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application is an application claiming priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 278,788 filed Jan. 14, 2016; U.S. Provisional Application No. 62 / 280,346 filed Jan. 19, 2016; U.S. Provisional Application No. 62 / 347,450 filed Jun. 8, 2016; and U.S. Provisional Application No. 62 / 397,527 filed Sep. 21, 2016, each of which is herein incorporated by reference in its entirety for all purposes.STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT[0002]Not ApplicableREFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK[0003]Not ApplicableBACKGROUND OF THE INVENTION[0004]C3 glomerulopathy (C3G) is a rare disease of the kidney (the prevalence of C3G is estimated at 2-3 per 1,000,000 people). C3G is characterized by deposition of the protein known as C3 (a component of the body's complement system) in the filtr...

Claims

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Application Information

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IPC IPC(8): A61K31/451A61K45/06A61K9/00
CPCA61K31/451A61K45/06A61K9/0053A61K31/454A61P13/12A61P13/00A61K31/517A61K31/551
Inventor BEKKER, PETRUS
Owner CHEMOCENTRYX INC
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