# US 10,864,197 B2 · Biphenyl sulfonamide compounds for the treatment of kidney diseases or disorders

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- Number: US 10,864,197 B2
- Document ID: US10864197B2
- Status: Granted
- Kind: B2
- Application number: 16/882,206
- Filed: 2020-05-22
- Published: 2020-09-10
- Granted: 2020-12-15
- Earliest claimed: 2016-10-13
- Assignees: Retrophin, Inc.
- Applicants: Retrophin, Inc.
- Inventors: Radko Komers; Alvin Shih
- Web page: https://patentgrep.com/patent/US10864197B2

## CPC

- A61K 31/422: not condensed and containing further heterocyclic rings
- A61P 13/12: of the kidneys
- 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

Methods of treatment comprising administering a compound having structure (I), or a pharmaceutically acceptable salt thereof, or administering a pharmaceutical composition comprising the compound of structure (I) or pharmaceutically acceptable salt thereof, are provided.

## Claims

### Claim 1

A method of treating Alport syndrome comprising administering to a subject in need thereof a pharmaceutical composition comprising a compound having structure (I),
or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said pharmaceutical composition is administered to the subject
(i) in an amount sufficient to achieve a urine protein to creatinine (“UP/C”) ratio of less than or equal to 1.5 g/g;
(ii) in an amount sufficient to achieve or maintain a UP/C ratio of less than or equal to 1.5 g/g; or
(iii) at a dosing regimen sufficient to achieve or maintain a UP/C ratio of less than or equal to 1.5 g/g.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition is administered to said subject over an administration period in an amount sufficient to achieve or maintain a UP/C ratio of less than or equal to 1.5 g/g for at least a portion of said administration period.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said subject has, or has had, a UP/C ratio greater than 1.5 g/g prior to administration of said pharmaceutical composition.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said pharmaceutical composition is administered to said subject for a period of 8 weeks, 26 weeks, or 8 months.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the amount of said compound having structure (I), or pharmaceutically acceptable salt thereof, administered to said subject is from about 50 mg/day to about 1000 mg/day.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the amount of said compound having structure (I), or pharmaceutically acceptable salt thereof, administered to said subject is from about 200 mg/day to about 800 mg/day.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the amount of said compound having structure (I), or pharmaceutically acceptable salt thereof, administered to said subject is about 200 mg/day.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the amount of said compound having structure (I), or pharmaceutically acceptable salt thereof, administered to said subject is about 400 mg/day.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the amount of said compound having structure (I), or pharmaceutically acceptable salt thereof, administered to said subject is about 800 mg/day.

### Claim 11 (depends on 1)

The method according to claim 1, wherein said administering comprises (1) an initial administration of said compound having structure (I), or a pharmaceutically acceptable salt thereof, to said subject at an initial dose; and (2) after said initial administration, a subsequent administration of said compound having structure (I), or a pharmaceutically acceptable salt thereof, to said subject at a subsequent dose, wherein said subsequent dose is greater than said initial dose.

### Claim 12 (depends on 11)

The method according to claim 11, wherein said initial dose is 400 mg/day and said subsequent dose is 800 mg/day.

### Claim 13 (depends on 11)

The method according to claim 11, wherein said initial dose is 200 mg/day and said subsequent dose is 400 mg/day.

### Claim 14 (depends on 13)

The method according to claim 13, wherein said subject is a child weighing less than 50 kg.

### Claim 15 (depends on 11)

The method according to claim 11, wherein said initial administration has a duration of 2 weeks.

### Claim 16 (depends on 11)

The method according to claim 11, wherein the method further comprises measuring the blood pressure of said subject before the subsequent administration.

### Claim 17 (depends on 1)

The method according to claim 1, wherein said compound has structure (I).

### Claim 18 (depends on 1)

The method according to claim 1, further comprising administering to said subject one or more additional therapeutic agents.
