METHODS OF TREATING BACTERIAL INFECTIONS

• US 20160339045A1
• Filed: 04/20/2016
• Published: 11/24/2016
• Est. Priority Date: 04/24/2015
• Status: Abandoned Application

• Current Assignee: Rempex Pharmaceuticals, Inc (Melinta Therapeutics, Inc.)
• Original Assignee: Rempex Pharmaceuticals, Inc (Melinta Therapeutics, Inc.)
• Inventors: Loutit, Jeffrey S., Griffith, David C., Dudley, Michael N., Lomovskaya, Olga
• Application Number:
  US15/134,198
• Publication Number:
  US 20160339045A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• CPC Class Codes: A61K 31/69 Boron compounds
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 31/04 Antibacterial agents

Abstract

Methods of treating or ameliorating a bacterial infection comprising administering a composition comprising a cyclic boronic acid ester Compound I in combination with meropenem are disclosed herewith. In some embodiments, the bacterial infection is a lower respiratory tract infection.

Claims

1. A method of treating or ameliorating a bacterial infection, comprising administering an effective amount of Compound I or a pharmaceutically acceptable salt thereof and meropenem to a subject in need thereof:

2. The method of claim 1, wherein the amount of Compound I or the pharmaceutically acceptable salt thereof is about 2.0 g.

3. The method of claim 1, wherein the amount of meropenem is about 2.0 g.

5. The method of claim 1, wherein Compound I or the pharmaceutically acceptable salt thereof and meropenem are administered at least once per day.

7. The method of claim 1, wherein the daily dose of Compound I or the pharmaceutically acceptable salt thereof is about 6.0 g and wherein the daily dose of meropenem is about 6.0 g.

8. The method of claim 1, wherein the administration is by intravenous infusion.

14. The method of claim 1, further comprises administering an additional medicament selected from an antibacterial agent, antifungal agent, an antiviral agent, an anti-inflammatory agent, or an anti-allergic agent.

4. (canceled)

6. (canceled)

9. (canceled)

10. (canceled)

11. (canceled)

12. (canceled)

13. (canceled)

15. A method of treating or ameliorating a bacterial infection, comprising

selecting for treatment a subject in need for treatment of a bacterial infection who is suffering from reduced renal function;

administering an effective amount of compound I or a pharmaceutically acceptable salt thereof and meropenem to said subject.

16. The method of claim 15, wherein said subject has a creatinine clearance of ≧

30 ml/min and <

50 ml/min.

17. The method of claim 15, wherein said subject has a creatinine clearance of ≧

20 ml/min and <

30 ml/min.

18. The method of claim 15, wherein said subject has a creatinine clearance of ≧

10 ml/min and <

20 ml/min.

19. The method of claim 15, wherein said subject has a creatinine clearance of <

10 ml/min.

22. The method of claim 15, wherein Compound I or the pharmaceutically acceptable salt thereof is administered in a dose of about 500 mg to about 1.0 g.

26. The method of claim 15, wherein meropenem is administered in a dose of about 500 mg to about 1.0 g.

31. The method of claim 15, wherein Compound I or the pharmaceutically acceptable salt thereof and meropenem are administered at least once per day.

38. The method of claim 15, wherein the administration is by intravenous infusion.

20. (canceled)

21. (canceled)

23. (canceled)

24. (canceled)

25. (canceled)

27. (canceled)

28. (canceled)

29. (canceled)

30. (canceled)

32. (canceled)

33. (canceled)

34. (canceled)

35. (canceled)

36. (canceled)

37. (canceled)

39. (canceled)

40. (canceled)

41. (canceled)

42. (canceled)

43. (canceled)

44. A method of treating or ameliorating a lower respiratory tract infection, comprising administering an effective amount of Compound I or a pharmaceutically acceptable salt thereof and meropenem to a subject in need thereof:

46. The method of claim 44, wherein Compound I or the pharmaceutically acceptable salt thereof is administered in a dose range from about 1.0 g to about 3.0 g.

48. The method of claim 44, wherein meropenem is administered in a dose range from about 1.0 g to about 3.0 g.

49. The method of claim 44, wherein both Compound I or the pharmaceutically acceptable salt thereof and meropenem are administered in a dose of about 2.0 g.

50. The method of claim 44, wherein Compound I or the pharmaceutically acceptable salt thereof and meropenem are administered at least once per day.

52. The method of claim 44, wherein the daily dose of Compound I or the pharmaceutically acceptable salt thereof is from about 3.0 g to about 6.0 g and wherein the daily dose of meropenem is from about 3.0 g to about 6.0 g.

53. The method of any one of claim 44, wherein the administration is by intravenous infusion.

59. The method of claim 44, wherein the subject is suffered from infections caused by enterobacteriaceae.

45. (canceled)

47. (canceled)

51. (canceled)

54. (canceled)

55. (canceled)

56. (canceled)

57. (canceled)

58. (canceled)