Treatment of fibrosis using FXR ligands

Patent metadata

Field	Value
Publication number	US-10258633-B2
Application number	US-201615299559-A
Country	US
Kind code	B2
Filing date	Oct 21, 2016
Priority date	Mar 12, 2004
Publication date	Apr 16, 2019
Grant date	Apr 16, 2019

Abstract

The present invention relates to a method for inhibiting fibrosis that occurs in an organ where the farnesoid X receptor (FXR) is expressed. This method involves the step of administering a high potency, activating ligand of FXR in an effective amount to a patient who is not suffering from a cholestatic condition. The invention also provides pharmaceutical compositions containing an effective amount of an FXR ligand and kits for dispensing the pharmaceutical compositions.

First claim

What is claimed is:

1. A method of treating liver fibrosis associated with alcoholic liver disease (ALD) in a human not suffering from a cholestatic condition in need thereof the method comprising the step of administering to the human 6-ethyl-chenodeoxycholic acid at a daily dose of 5-500 mg orally.

2. The method of claim 1 wherein the cholestatic condition is defined as having abnormally elevated serum levels of alkaline phosphatase, γ-glutamyltranspeptidase (GGT), and 5′ nucleotidase.

3. The method of claim 2 , wherein the cholestatic condition is further defined as presenting with at least one clinical symptom.

4. The method of claim 3 , wherein the symptom is itching (pruritus).

5. The method of claim 1 , wherein the cholestatic condition is selected from the group consisting of primary biliary cirrhosis, primary sclerosing cholangitis, drug-induced cholestasis, hereditary cholestasis, and intrahepatic cholestasis of pregnancy.

6. The method of claim 1 , wherein the human is not suffering from a cholestatic condition associated with a disease or condition selected from the group consisting of primary liver and biliary cancer, metastatic cancer, sepsis, chronic total parenteral nutrition, cystic fibrosis, and granulomatous liver disease.

Assignees

• Fiorucci Stefano
• Pellicciari Roberto
• Pruzanski Mark
• Intercept Pharmaceuticals Inc

Inventors

• Fiorucci Stefano
• Pellicciari Roberto
• Pruzanski Mark

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P7/02

  Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P31/20

  for DNA viruses · CPC title