# US 10,117,855 B2 · Methods of treatment for cholestatic and fibrotic diseases

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- Number: US 10,117,855 B2
- Document ID: US10117855B2
- Status: Granted
- Kind: B2
- Application number: 15/841,777
- Filed: 2017-12-14
- Published: 2018-04-05
- Granted: 2018-11-06
- Earliest claimed: 2016-04-11
- Assignees: Genfit
- Applicants: Genfit
- Inventors: Raphael Darteil; Robert Walczak; Carole Belanger; Emilie Negro; Pierre Daubersies; Philippe Delataille
- Web page: https://patentgrep.com/patent/US10117855B2

## CPC

- A61K 31/426: 1,3-Thiazoles
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 27/02: Ophthalmic agents
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to the compound [2-[(5-nitro-1,3-thiazol-2-yl)carbamoyl]phenyl]ethanoate (Nitazoxanide) or 2-hydroxy-N-(5-nitro-2-thiazolyl)benzamide (Tizoxanide) for treating cholestatic and fibrotic diseases.

## Claims

### Claim 1

A method for treating pulmonary fibrosis comprising administering to a subject in need thereof a therapeutic effective amount of a compound selected in the group consisting of Nitazoxanide (NTZ), Tizoxanide (TZ), and a pharmaceutically acceptable salt of NTZ or TZ.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the compound is administered orally.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the compound is administered in an amount comprised between 100 mg/day and 2000 mg/day.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the compound is administered in the form of a pharmaceutical composition providing prolonged or slow release of the compound.

### Claim 5 (depends on 1)

The method according to claim 1, wherein pulmonary fibrosis is idiopathic pulmonary fibrosis or progressive massive fibrosis.

### Claim 6 (depends on 1)

The method according to claim 1, wherein pulmonary fibrosis is consecutive to a chronic inflammatory airway disease.

### Claim 7 (depends on 1)

The method according to claim 1, wherein pulmonary fibrosis is consecutive to chronic obstructive pulmonary disease, to asthma, to emphysema, to smoking, to tuberculosis or to coal worker's pneumoconiosis.

### Claim 8

A method for treating pulmonary fibrosis comprising administering to a subject in need thereof a therapeutic effective amount of nitazoxanide.

### Claim 9 (depends on 8)

The method according to claim 8, wherein nitazoxanide is administered orally.

### Claim 10 (depends on 8)

The method according to claim 8, wherein nitazoxanide is administered in an amount comprised 100 mg/day and 2000 mg/day.

### Claim 11 (depends on 8)

The method according to claim 8, wherein nitazoxanide is administered in the form of a pharmaceutical composition providing prolonged or slow release of nitazoxanide.

### Claim 12 (depends on 8)

The method according to claim 8, wherein pulmonary fibrosis is Idiopathic pulmonary fibrosis or progressive massive fibrosis.

### Claim 13 (depends on 8)

The method according to claim 8, wherein pulmonary fibrosis is consecutive to a chronic inflammatory airway disease.

### Claim 14 (depends on 8)

The method according to claim 8, wherein pulmonary fibrosis is consecutive to chronic obstructive pulmonary disease, to asthma, to emphysema, to smoking, to tuberculosis or to coal worker's pneumoconiosis.