# US 2021/0275558 A1 · Methods for treating, pharmaceutical compositions and uses thereof

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2021/0275558 A1
- Document ID: US20210275558A1
- Status: Published application
- Kind: A1
- Application number: 17/261,695
- Filed: 2019-07-23
- Published: 2021-09-09
- Earliest claimed: 2018-07-25
- Assignees: Boehringer Ingelheim International GmbH; Georg-August-Universitaet Goettingen Stiftung Oeffentlichen Rechts, Universitaetsmedizin
- Applicants: Boehringer Ingelheim International GmbH; Georg-August Universitaet Goettingen Stiftung Oeffentlichen Rechts, Universitaetsmedizin
- Inventors: Maximilian Von Eynatten; Oliver Gross; Sibylle Jenny Hauske
- Web page: https://patentgrep.com/patent/US20210275558A1

## CPC

- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/28: Dragees; Coated pills or tablets {, e.g. with film or compression coating (A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 13/10: of the bladder
- 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

The present invention relates to methods, pharmaceutical compositions and uses thereof for treating and alleviating Alport syndrome, various aspects and symptoms associated with Alport syndrome in a patient in need thereof comprising administering empagliflozin to the patient.

## Claims

### Claim 1

A method comprising:
administering empagliflozin to a patient in order to at least one of:
(i) treat Alport syndrome in the patient;
(ii) improve renal function or delay or slow an impairment of the renal function in the patient diagnosed with Alport syndrome;
(iii) delay progression of chronic kidney disease in the patient diagnosed with Alport syndrome;
(iv) treat or alleviate glomerular hypertension in the patient diagnosed with Alport syndrome;
(v) treat, including slowing or reversing the progression of, albuminuria and/or proteinuria in the patient diagnosed with Alport syndrome;
(vi) improve a glomerular filtration rate or delay or slow a decline of the glomerular filtration rate in the patient diagnosed with Alport syndrome.

### Claim at position 2

-6. (canceled)

### Claim 7 (depends on 1)

The method according to claim 1, wherein the patient has an eGFR equal to or greater than 20 mL/min/1.73m2.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the adult patient has an eGFR lower than 75 mL/min/1.73 m2 or lower than 90 mL/min/1.73m2.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the patient has an elevated protein-to-creatinine ratio (PCR) greater or equal than 300 mg/g creatinine, an elevated level of proteinuria of equal or greater than 200 mg protein per day (24 h urine protein) or an elevated albumin-to-creatinine ratio (ACR) greater or equal than 200 mg/g creatinine or greater or equal than 300 mg/g creatinine.

### Claim 10 (depends on 1)

The method according to claim 1, wherein empagliflozin is administered at a dose in a range from 1 mg to 25 mg per day to the patient.

### Claim 11 (depends on 10)

The method according to claim 10 wherein empagliflozin is administered at a dose of 10 mg per day to the patient.

### Claim 12 (depends on 1)

The method according to claim 1, wherein empagliflozin is administered in combination with one or more other therapeutic substances to the patient.

### Claim 13 (depends on 12)

The method according to claim 12 wherein the one or more other therapeutic substances are selected from the group consisting of angiotensin receptor blockers (ARB), angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, aldosterone antagonists, diuretics, angiotensin receptor-neprilysin inhibitor (ARNi), calcium channel blockers, mineralcorticoid receptor antagonists and ivabradine.

### Claim 14

A pharmaceutical composition comprising empagliflozin for use in a method, comprising:
administering empagliflozin to a patient in order to at least one of:
(i) treat Alport syndrome in the patient;
(ii) improve renal function or delay or slow an impairment of the renal function in the patient diagnosed with Alport syndrome;
(iii) delay progression of chronic kidney disease in the patient diagnosed with Alport syndrome;
(iv) treat or alleviate glomerular hypertension in the patient diagnosed with Alport syndrome;
(v) treat, including slowing or reversing the progression of, albuminuria and/or proteinuria in the patient diagnosed with Alport syndrome;
(vi) improve a glomerular filtration rate or delay or slow a decline of the glomerular filtration rate in the patient diagnosed with Alport syndrome.

### Claim 15 (depends on 14)

The pharmaceutical composition according to claim 14 comprising empagliflozin in combination with one or more other therapeutic substances selected from the group consisting of angiotensin receptor blockers (ARB), angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, aldosterone antagonists, diuretics, angiotensin receptor-neprilysin inhibitor (ARNi), calcium channel blockers, mineralcorticoid receptor antagonists and ivabradine.

### Claim 16 (depends on 14)

The pharmaceutical composition according to claim 14, comprising an amount of 1 to 25 mg of empagliflozin.
