# US 12,005,050 B2 · Methods for preventing or treating H. pylori infection

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- Number: US 12,005,050 B2
- Document ID: US12005050B2
- Status: Granted
- Kind: B2
- Application number: 18/363,006
- Filed: 2023-08-01
- Published: 2024-03-14
- Granted: 2024-06-11
- Earliest claimed: 2022-08-18
- Assignees: Tennor Therapeutics (Suzhou) Limited
- Applicants: Tennor Therapeutics (Suzhou) Limited
- Inventors: Zhenkun Ma; Guozhu Geng; Jing Chen; Yu Liu; Xiangyi Xu; Changlin Ai; Junlei Zhang; Ting Song; Shuangshuang Zhao
- Web page: https://patentgrep.com/patent/US12005050B2

## CPC

- A61K 31/439: the ring forming part of a bridged ring system, e.g. quinuclidine (8-azabicyclo [3.2.1] octanes A61K31/46)
- 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 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 31/438: The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 31/04: Antibacterial agents
- 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 disclosure provides methods, drug combinations and kits for treating, ameliorating, reversing and/or preventing a Helicobacter pylori (H. pylori) infection in a patient in need thereof.

## Claims

### Claim 1

A method for treating, ameliorating, and/or reversing a Helicobacter pylori (H. pylori) infection in a patient in need thereof, comprising administering to said patient:
an effective amount of compound I 4-Deoxy-3,4-(1H)-imidazo-(2,5-dihydro)rifamycin, or a pharmaceutically acceptable salt thereof; an effective amount of an additional antibiotic, and an effective amount of an acid blocker,
wherein said compound I is administered to said patient at a dose of about 400 mg to about 600 mg, twice per day (BID) or three times per day (TID),
wherein said compound I is a compound of Formula 2
wherein an effective amount of said acid blocker is at a dose of about 10 mg to about 20 mg, and said acid blocker is proton pump inhibitor (PPI); and,
wherein an effective amount of said additional antibiotic is twice per day (BID) or three times per day (TID), for 7-14 consecutive days; and said additional antibiotic is amoxicillin.

### Claim 2 (depends on 1)

The method of claim 1, wherein said compound I is administered to said patient for 7-14 consecutive days.

### Claim 3 (depends on 1)

The method of claim 1, wherein said compound I is administered in one or more dosage units, and each said dosage unit comprises about 100 mg to about 400 mg of said compound I.

### Claim 4 (depends on 1)

The method of claim 1, wherein said compound I is administered as a capsule or a tablet.

### Claim 5 (depends on 1)

The method of claim 1, wherein said acid blocker is administered to said patient at a dose of about 10 mg to about 40 mg, twice per day (BID) or three times per day (TID).

### Claim 6 (depends on 1)

The method of claim 1, wherein said acid blocker is administered to said patient for at least 7-14 consecutive days.

### Claim 7 (depends on 1)

The method of claim 1, wherein said acid blocker is administered as an enteric-coated tablet.

### Claim 8 (depends on 7)

The method of claim 7, wherein each said enteric-coated tablet comprises about 10 mg to about 20 mg of said acid blocker.

### Claim 9 (depends on 1)

The method of claim 1, wherein said acid blocker is selected from the group consisting of: rabeprazole sodium, esomeprazole magnesium, omeprazole, lansoprazole, pantoprazole sodium and ilaprazole.

### Claim 10 (depends on 1)

The method of claim 1, wherein said additional antibiotic is administered to said patient at a dose of about 100 mg to about 1000 mg, twice per day (BID) or three times per day (TID).

### Claim 11 (depends on 1)

The method of claim 1, wherein said additional antibiotic is administered to said patient for 7-14 consecutive days.

### Claim 12 (depends on 1)

The method of claim 1, wherein said Helicobacter pylori is resistant to one or more antibiotics selected from the group consisting of clarithromycin, amoxicillin, metronidazole, levofloxacin, tetracycline, furazolidone and rifabutin.

### Claim 13

A drug combination, comprising an effective amount of compound I 4-Deoxy-3,4-(1H)-imidazo-(2,5-dihydro)rifamycin, or a pharmaceutically acceptable salt thereof; an effective amount of an acid blocker, and an effective amount of an additional antibiotic, wherein said acid blocker is a proton pump inhibitor (PPD), said compound I is a compound of Formula 2
and
wherein said additional antibiotic is amoxicillin.

### Claim 14 (depends on 13)

A kit, comprising the drug combination of claim 13.
