# US 11,998,533 B2 · Pharmaceutical compositions comprising LTV-17 and beta-lactamase inhibitors and their use as antibacterial agents

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- Number: US 11,998,533 B2
- Document ID: US11998533B2
- Status: Granted
- Kind: B2
- Application number: 17/984,553
- Filed: 2022-11-10
- Published: 2023-05-18
- Granted: 2024-06-04
- Earliest claimed: 2021-11-12
- Assignees: Fedora Pharmaceuticals Inc.
- Applicants: Fedora Pharmaceuticals Inc.
- Inventors: Sameeh M. Salama; Samarendra N. Maiti; Renata Jankowska
- Web page: https://patentgrep.com/patent/US11998533B2

## CPC

- A61K 31/427: not condensed and containing further heterocyclic rings
- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A61K 31/551: having two nitrogen atoms, e.g. dilazep
- 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

Pharmaceutical combinations of LTV-17 (I), a lactivicin derivative, and β-lactamase inhibitors are provided, wherein the combinations comprise antibacterial agents suitable for use in the treatment or prevention of bacterial infections.

## Claims

### Claim 1

A synergistic pharmaceutical combination comprising compound LTV-17 (I) or a pharmaceutically acceptable salt thereof, solvate thereof, or solvate of the salt thereof:
and one or more β-lactamase inhibitor or a pharmaceutically acceptable salt thereof or a biologically hydrolysable prodrug thereof.

### Claim 2 (depends on 1)

The synergistic pharmaceutical combination of claim 1, wherein the one or more β-lactamase inhibitor is selected from the group consisting of compounds (IIa) to (IIz′):

### Claim 3 (depends on 1)

The synergistic pharmaceutical combination of claim 1 for use in treating and/or preventing diseases, in particular bacterial infections, especially Gram-negative bacterial infections.

### Claim 4 (depends on 1)

The synergistic pharmaceutical combination of claim 1, wherein the combination comprises a ratio of LTV-17 (I) to β-lactamase inhibitor in a range of 20:1 to 1:20, by weight.

### Claim 5 (depends on 4)

The synergistic pharmaceutical combination of claim 4, wherein ratio is in the range of 1:1 to 1:20.

### Claim 6 (depends on 1)

The synergistic pharmaceutical combination of claim 1, for use as a medicament for treating and/or preventing bacterial infections in humans and in veterinary medicine.

### Claim 7 (depends on 1)

The synergistic pharmaceutical combination of claim 1, further comprising a pharmaceutically acceptable diluent, excipient or carrier.

### Claim 8

A method of treating or preventing a bacterial infection in a subject, comprising administering a therapeutically effective amount of pharmaceutical combination comprising compound LTV-17 (I) or a pharmaceutically acceptable salt thereof, solvate thereof, or solvate of the salt thereof:
and one or more β-lactamase inhibitor or a pharmaceutically acceptable salt thereof or a biologically hydrolysable prodrug thereof, to a subject having a bacterial infection, wherein the combination has a synergistic anti-bacterial effect.

### Claim 9 (depends on 8)

The method of claim 8, wherein the one or more β-lactamase inhibitor is selected from the group consisting of compounds (IIa) to (IIz′):

### Claim 10 (depends on 8)

The method of claim 8, wherein the bacterial infection is caused by Gram-negative bacteria.

### Claim 11 (depends on 8)

The method of claim 8, wherein the subject is a human.

### Claim 12 (depends on 8)

The method of claim 8, wherein the combination comprises a ratio of LTV-17 (I) to β-lactamase inhibitor in a range of 20:1 to 1:20, by weight.

### Claim 13 (depends on 12)

The method of claim 12, wherein the ratio is in the range of 1:1 to 1:20.

### Claim 14 (depends on 8)

The method of claim 8, wherein the pharmaceutical combination further comprises a pharmaceutically acceptable diluent, excipient or carrier.