Claims for Patent: 9,763,918

Summary for Patent: 9,763,918

Title:	Compositions and methods for treating chronic urticaria
Abstract:	Disclosed herein are methods of treating conditions, which may be associated with elevated levels of mast cells, basophils, eosinophils, or a combination thereof, with a therapeutically effective amount of dexpramipexole or pharmaceutical acceptable salt thereof.
Inventor(s):	Bozik; Michael E. (Pittsburgh, PA), Dworetzky; Steven (Jefferson Hills, PA)
Assignee:	Knopp Biosciences LLC (Pittsburgh, PA)
Application Number:	14/912,015
Patent Claims:	1. A method of treating a condition characterized by elevated levels of mast cells, elevated levels of activation of mast cells, elevated levels of basophils, elevated levels of activation of basophils, elevated levels of eosinophils, elevated levels of activation of eosinophils, or a combination thereof in a subject, comprising administering to a subject in need thereof, a therapeutically effective amount of dexpramipexole; wherein the condition is selected from the group consisting of chronic urticaria, chronic idiopathic urticaria, chronic autoimmune urticaria, aquagenic urticaria, cholinergic urticaria, contact urticaria, exercise-induced urticaria, physical urticaria, acquired cold urticaria, delayed pressure urticaria, heat urticaria, solar urticaria, demographic urticaria, urticaria factitia, uticaria pigmentosa, and any combination thereof. 2. The method of claim 1, wherein the therapeutically effective dose is selected from a group consisting of about 1 mg to about 1,000 mg per day, about 50 mg to about 600 mg per day, and about 150 mg to about 300 mg per day. 3. The method of claim 1, wherein the therapeutically effective amount is selected from a group consisting of at least about 150 mg, at least about 300 mg, and at least about 600 mg. 4. The method of claim 1, wherein administering is selected from a group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering an amount equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours. 5. The method of claim 1, wherein administering comprises administering about 150 mg two times per day. 6. The method of claim 1 further comprising an induction step, wherein said induction step is selected from a group consisting of administering a therapeutic agent that is capable of decreasing mast cell levels, decreasing basophil levels, decreasing eosinophil levels, decreasing the activation level of mast cells, decreasing the activation level of basophils, decreasing the activation level of eosinophils, and a combination thereof; wherein the therapeutic agent is selected from the group consisting of a glucocorticoid, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a tyrosine kinase inhibitor, a fusion protein, a monoclonal antibody directed against one or more pro-inflammatory cytokines, a chemotherapeutic agent, a phenolic antioxidant, an anti-proliferative drug, an anti IL-5 monoclonal antibody, an IL-5 receptor monoclonal antibody, an anti IL-13 monoclonal antibody, an anti IL-13 receptor monoclonal antibody, an anti IL-4 monoclonal antibody, an anti IL-4 receptor monoclonal antibody, an anti IgE monoclonal antibody, a TNF-.alpha. inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof. 7. A method of treating a chronic urticaria in a subject, comprising administering to a subject in need thereof, a therapeutically effective amount of dexpramipexole. 8. The method of claim 7, wherein the chronic urticaria is selected from a group consisting of chronic idiopathic urticaria, chronic autoimmune urticaria, aquagenic urticaria, cholinergic urticaria, contact urticaria, exercise-induced urticaria, physical urticaria, acquired cold urticaria, delayed pressure urticaria, heat urticaria, solar urticaria, demographic urticaria, urticaria factitia, and any combination thereof. 9. The method of claim 7, wherein the therapeutically effective amount is selected from a group consisting of about 1 mg to about 1,000 mg per day, about 50 mg to about 600 mg per day, and about 150 mg to about 300 mg per day. 10. The method of claim 7, wherein the therapeutically effective amount is selected from a group consisting of at least about 150 mg, at least about 300 mg, and at least about 600 mg. 11. The method of claim 7, wherein administering is selected from a group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering an amount equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours. 12. The method of claim 7, wherein administering comprises administering about 150 mg two times per day. 13. The method of claim 7, further comprising an induction step, wherein said induction step is selected from a group consisting of administering a therapeutic agent that is capable of decreasing mast cell levels, decreasing basophil levels, decreasing eosinophil levels, decreasing the activation level of mast cells, decreasing the activation level of basophils, decreasing the activation level of eosinophils, and a combination thereof; wherein the therapeutic agent is selected from the group consisting of a glucocorticoid, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a tyrosine kinase inhibitor, a fusion protein, a monoclonal antibody directed against one or more pro-inflammatory cytokines, a chemotherapeutic agent, a phenolic antioxidant, an anti-proliferative drug, an anti-proliferative drug, an anti IL-5 monoclonal antibody, an IL-5 receptor monoclonal antibody, an anti IL-13 monoclonal antibody, an anti IL-13 receptor monoclonal antibody, an anti IL-4 monoclonal antibody, an anti IL-4 receptor monoclonal antibody, an anti IgE monoclonal antibody, a TNF-.alpha. inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof. 14. The method of claim 6, wherein the tyrosine kinase inhibitor is imatinib. 15. The method of claim 6, wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab and reslizumab. 16. The method of claim 6, wherein the IL-5 receptor monoclonal antibody is benralizumab. 17. The method of claim 6, wherein the anti IL-13 monoclonal antibody is lebrikizumab. 18. The method of claim 6, wherein the anti IL-4 receptor monoclonal antibody is dupilumab. 19. The method of claim 6, wherein the anti IgE monoclonal antibody is omalizumab. 20. The method of claim 6, wherein the TNF-.alpha. inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, and golimumab. 21. The method of claim 6, wherein the fusion protein is etanercept. 22. The method of claim 13, wherein the tyrosine kinase inhibitor is imatinib. 23. The method of claim 13, wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab and reslizumab. 24. The method of claim 13, wherein the IL-5 receptor monoclonal antibody is benralizumab. 25. The method of claim 13, wherein the anti IL-13 monoclonal antibody is lebrikizumab. 26. The method of claim 13, wherein the anti IL-4 receptor monoclonal antibody is dupilumab. 27. The method of claim 13, wherein the anti IgE monoclonal antibody is omalizumab. 28. The method of claim 13, wherein the TNF-.alpha. inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, and golimumab. 29. The method of claim 13, wherein the fusion protein is etanercept. 30. The method of claim 1, wherein administering comprises administering about 75 mg two times per day. 31. The method of claim 1, wherein administering comprises administering about 300 mg two times per day. 32. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole is administered as an initial dosing regimen and then as a maintenance dosing regimen. 33. The method of claim 32, wherein the therapeutically effective amount of the initial dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 34. The method of claim 32, wherein the therapeutically effective amount of the maintenance dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 35. The method of claim 7, wherein administering comprises administering about 75 mg two times per day. 36. The method of claim 7, wherein administering comprises administering about 300 mg two times per day. 37. The method of claim 7, wherein the therapeutically effective amount of dexpramipexole is administered as an initial dosing regimen and then as a maintenance dosing regimen. 38. The method of claim 37, wherein the therapeutically effective amount of the initial dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 39. The method of claim 37, wherein the therapeutically effective amount of the maintenance dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 40. A method of treating a condition characterized by elevated levels of mast cells, elevated levels of activation of mast cells, elevated levels of basophils, elevated levels of activation of basophils, elevated levels of eosinophils, elevated levels of activation of eosinophils, or a combination thereof in a subject, comprising administering to a subject in need thereof, a therapeutically effective amount of dexpramipexole; wherein the condition is selected from the group consisting of allergy, herpes stromal keratitis, ulcerative colitis, erythroderma, juvenile rheumatoid arthritis, an endocrinopathy, diabetes mellitus, basophilia due to estrogen administration, hypothyroidism (myxedema), viral infection, tuberculosis, iron deficiency, exposure to ionizing radiation, a neoplasia such as basophilic leukemia, chronic myelogenous leukemia, polycythemia vera, primary myelofibrosis, essential thrombocythemia, mastocytosis, cutaneous mastocytosis, systemic mastocytosis, telangiectasia macularis eruptiva perstans, mast cell activation, mast cell activation syndrome, mast cell leukemia, mast cell sarcoma, and a combination thereof. 41. The method of claim 40, wherein the therapeutically effective dose is selected from a group consisting of about 1 mg to about 1,000 mg per day, about 50 mg to about 600 mg per day, and about 150 mg to about 300 mg per day. 42. The method of claim 40, wherein the therapeutically effective amount is selected from a group consisting of at least about 150 mg, at least about 300 mg, and at least about 600 mg. 43. The method of claim 40, wherein administering is selected from a group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering an amount equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours. 44. The method of claim 40, wherein administering comprises administering about 150 mg two times per day. 45. The method of claim 40, wherein administering comprises administering about 75 mg two times per day. 46. The method of claim 40, wherein administering comprises administering about 300 mg two times per day. 47. The method of claim 40, wherein the therapeutically effective amount of dexpramipexole is administered as an initial dosing regimen and then as a maintenance dosing regimen. 48. The method of claim 47, wherein the therapeutically effective amount of the initial dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 49. The method of claim 47, wherein the therapeutically effective amount of the maintenance dosing regimen is selected from the group consisting of about 50 mg to about 1500 mg per day, about 150 mg to about 300 mg per day, about 300 mg to about 500 mg per day, and about 300 mg to about 600 mg per day. 50. The method of claim 40, further comprising an induction step, wherein said induction step is selected from a group consisting of administering a therapeutic agent that is capable of decreasing mast cell levels, decreasing basophil levels, decreasing eosinophil levels, decreasing the activation level of mast cells, decreasing the activation level of basophils, decreasing the activation level of eosinophils, and a combination thereof; wherein the therapeutic agent is selected from the group consisting of a glucocorticoid, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a tyrosine kinase inhibitor, a fusion protein, a monoclonal antibody directed against one or more pro-inflammatory cytokines, a chemotherapeutic agent, a phenolic antioxidant, an anti-proliferative drug, an anti IL-5 monoclonal antibody, an IL-5 receptor monoclonal antibody, an anti IL-13 monoclonal antibody, an anti IL-13 receptor monoclonal antibody, an anti IL-4 monoclonal antibody, an anti IL-4 receptor monoclonal antibody, an anti IgE monoclonal antibody, a TNF-.alpha. inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof. 51. The method of claim 50, wherein the tyrosine kinase inhibitor is imatinib. 52. The method of claim 50, wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab and reslizumab. 53. The method of claim 50, wherein the IL-5 receptor monoclonal antibody is benralizumab. 54. The method of claim 50, wherein the anti IL-13 monoclonal antibody is lebrikizumab. 55. The method of claim 50, wherein the anti IL-4 receptor monoclonal antibody is dupilumab. 56. The method of claim 50, wherein the anti IgE monoclonal antibody is omalizumab. 57. The method of claim 50, wherein the TNF-.alpha. inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, and golimumab. 58. The method of claim 50, wherein the fusion protein is etanercept. 59. The method of claim 1, wherein the therapeutically effective amount is administered orally. 60. The method of claim 1, wherein the therapeutically effective amount is administered topically. 61. The method of claim 7, wherein the therapeutically effective amount is administered orally. 62. The method of claim 7, wherein the therapeutically effective amount is administered topically. 63. The method of claim 40, wherein the therapeutically effective amount is administered orally. 64. The method of claim 40, wherein the therapeutically effective amount is administered topically.

Details for Patent 9,763,918

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2033-08-13
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2033-08-13
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2033-08-13
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2033-08-13
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2033-08-13
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2033-08-13