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Claims for Patent: 7,304,036

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Claims for Patent: 7,304,036

Title:Methods and compositions for the treatment of gastrointestinal disorders
Abstract: The present invention features compositions and related methods for treating IBS and other gastrointestinal disorders and conditions (e.g., gastrointestinal motility disorders, functional gastrointestinal disorders, gastroesophageal reflux disease (GERD), Crohn's disease, ulcerative colitis, Inflammatory bowel disease, functional heartburn, dyspepsia (including functional dyspepsia or nonulcer dyspepsia), gastroparesis, chronic intestinal pseudo-obstruction (or colonic pseudo-obstruction), and disorders and conditions associated with constipation, e.g., constipation associated with use of opiate pain killers, post-surgical constipation (post-operative ileus), and constipation associated with neuropathic disorders as well as other conditions and disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Inventor(s): Currie; Mark G. (Sterling, MA), Mahajan-Miklos; Shalina (Stanford, CA), Norman; Thea (San Diego, CA), Milne; G. Todd (Brookline, MA)
Assignee: Microbia, Inc. (Cambridge, MA)
Application Number:10/796,719
Patent Claims: 1. A purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31) or a pharmacologically acceptable salt thereof.

2. A purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31).

3. A pharmacologically acceptable salt of a purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31).

4. A purified peptide comprising the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31) or a pharmacologically acceptable salt thereof, wherein the peptide activates the guanylate cyclase C receptor.

5. A purified peptide comprising the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:3 1), wherein the peptide activates the guanylate cyclase C receptor.

6. A pharmacologically acceptable salt of a purified peptide comprising the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31), wherein the peptide activates the guanylate cyclase C receptor.

7. A pharmaceutical composition comprising the purified peptide of any of claims 1 and 2-6 and a pharmaceutically acceptable carrier or excipient.

8. A pharmaceutical composition comprising: (a) a purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31) or a pharmacologically acceptable salt thereof; and (b) a pharmaceutically acceptable carrier or excipient.

9. A pharmaceutical composition comprising: (a) a purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31); and (b) a pharmaceutically acceptable carrier or excipient.

10. A pharmaceutical composition comprising: (a) a pharmacologically acceptable salt of a purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31); and (b) a pharmaceutically acceptable carrier or excipient.

11. A pharmaceutical composition comprising: (a) a purified peptide comprising the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31) or a pharmacologically acceptable salt thereof; and (b) a pharmaceutically acceptable carrier or excipient.

12. A pharmaceutical composition comprising: (a) a purified peptide comprising f the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31); and (b) a pharmaceutically acceptable carrier or excipient.

13. A pharmaceutical composition comprising: (a) a pharmacologically acceptable salt of a purified peptide comprising the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31); and (b) a pharmaceutically acceptable carrier or excipient.

14. A method for increasing intestinal motility in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

15. A method for treating a patient suffering from irritable bowel syndrome, the method comprising administering to the patient an effective of amount of the pharmaceutical composition of claim 7.

16. The method of claim 15 wherein the patient is suffering from constipation-predominant irritable bowel syndrome.

17. The method of claim 15 wherein the patient is suffering from alternating irritable bowel syndrome.

18. A method for treating constipation in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

19. The method of claim 18 wherein the patient is suffering from chronic constipation.

20. The method of claim 18 wherein the patient is suffering from idiopathic constipation.

21. The method of claim 18 wherein the patient is suffering from post-operative ileus.

22. The method of claim 18 wherein the constipation is caused by opiate use.

23. A method for treating dyspepsia in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

24. A method for treating gastroparesis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

25. A method for treating chronic intestinal pseudo obstruction in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

26. A method for treating Crohn's disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

27. A method for treating ulcerative colitis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

28. A method for treating inflammatory bowel disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 7.

29. A method for increasing intestinal motility in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

30. A method for increasing intestinal motility in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

31. A method for increasing intestinal motility in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

32. A method for increasing intestinal motility in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

33. A method for treating a patient suffering from irritable bowel syndrome, the method comprising administering to the patient an effective of amount of the pharmaceutical composition of claim 9.

34. A method for treating a patient suffering from irritable bowel syndrome, the method comprising administering to the patient an effective of amount of the pharmaceutical composition of claim 10.

35. A method for treating a patient suffering from irritable bowel syndrome, the method comprising administering to the patient an effective of amount of the pharmaceutical composition of claim 12.

36. A method for treating a patient suffering from irritable bowel syndrome, the method comprising administering to the patient an effective of amount of the pharmaceutical composition of claim 13.

37. The method of any of claims 33-36 wherein the patient is suffering from constipation-predominant irritable bowel syndrome.

38. The method of any of claims 33-36 wherein the patient is suffering from alternating irritable bowel syndrome.

39. A method for treating constipation in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

40. A method for treating constipation in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

41. A method for treating constipation in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

42. A method for treating constipation in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

43. The method of any of claims 39-42 wherein the patient is suffering from chronic constipation.

44. The method of any of claims 39-42 wherein the patient is suffering from idiopathic constipation.

45. The method of any of claims 39-42 wherein the patient is suffering from post-operative ileus.

46. The method of any of claims 39-42 wherein the constipation is caused by opiate use.

47. A method for treating dyspepsia in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

48. A method for treating dyspepsia in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

49. A method for treating dyspepsia in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 11.

50. A method for treating dyspepsia in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

51. A method for treating gastroparesis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

52. A method for treating gastroparesis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

53. A method for treating gastroparesis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

54. A method for treating gastroparesis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

55. A method for treating chronic intestinal pseudo obstruction in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

56. A method for treating chronic intestinal pseudo obstruction in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

57. A method for treating chronic intestinal pseudo obstruction in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

58. A method for treating chronic intestinal pseudo obstruction in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

59. A method for treating Crohn's disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

60. A method for treating Crohn's disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

61. A method for treating Crohn's disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

62. A method for treating Crohn's disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

63. A method for treating ulcerative colitis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

64. A method for treating ulcerative colitis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

65. A method for treating ulcerative colitis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

66. A method for treating ulcerative colitis in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.

67. A method for treating inflammatory bowel disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 9.

68. A method for treating inflammatory bowel disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 10.

69. A method for treating inflammatory bowel disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 12.

70. A method for treating inflammatory bowel disease in a patient, the method comprising administering to the patient an effective amount of the pharmaceutical composition of claim 13.
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