Claims for Patent: 9,795,627

Summary for Patent: 9,795,627

Title:	Method for prevention of colectomy
Abstract:	A method of treating chronic active ulcerative colitis in a subject that is refractory or responds insufficiently or is intolerant to anti-inflammatory therapy, comprises administering to a patient in need thereof an effective exposure of an oligonucleotide comprising the sequence 5\'-GGAACAGTTCGTCCATGGC-3\' (SEQ ID NO.2), wherein at least one CG dinucleotide is unmethylated. The oligonucleotide is not administered with corticosteroids or glucocorticosteroids.
Inventor(s):	Admyre; Charlotte (Vendelso, SE), Zargari; Arezou (Solna, SE), Von Stein; Oliver (Upplands Vasby, SE), Von Stein; Petra (Upplands Vasby, SE)
Assignee:	INDEX PHARMACEUTICALS AB (Stockholm, SE)
Application Number:	15/264,709
Patent Claims:	1. A method of treating chronic active ulcerative colitis in a subject that is refractory or responds insufficiently or is intolerant to anti-inflammatory therapy, comprising administering to the subject an effective exposure of an oligonucleotide comprising the sequence 5'-GGAACAGTTCGTCCATGGC-3' (SEQ ID NO:2), wherein at least one CG dinucleotide is unmethylated, and wherein said oligonucleotide is not administered in combination with corticosteroid or glucocorticosteroid. 2. The method of claim 1, wherein at least one nucleotide in said oligonucleotide has a backbone modification. 3. The method of claim 2, wherein said backbone modification is a phosphate backbone modification represented by a phosphorothioate or a phosphorodithioate modification. 4. The method of claim 2, wherein said backbone modification is located in the 5'- and/or the 3'-end of said oligonucleotide. 5. The method of claim 1, wherein said oligonucleotide has the sequence 5'-G*G*A*ACAGTTCGTCCAT*G*G*C-3' (SEQ ID NO:1), wherein the CG dinucleotide is unmethylated. 6. The method of claim 1, wherein individual doses of said oligonucleotide are repetitively administered as a single exposure. 7. The method of claim 1, wherein two or more doses of said oligonucleotide are administered on two or more separate occasions 4 to 70 weeks apart. 8. The method of claim 1, wherein the amount of said oligonucleotide administered is in the range from about 0.3 mg to about 100 mg. 9. The method of claim 1, wherein the amount of said oligonucleotide administered is in the range from about 25 mg to about 60 mg. 10. The method of claim 1, wherein the amount of said oligonucleotide administered is about 30 mg. 11. The method of claim 1, wherein said oligonucleotide is administered in combination with one or more other drugs. 12. The method of claim 1, wherein said oligonucleotide is administered in combination with one or more immunomodulatory drugs or anti-TNF therapy drugs. 13. The method of claim 1, wherein said oligonucleotide is administered in combination with one or more of cylclosporine, Infliximab, Adallilumab, natural IFN-.beta., S-Ompeprazol, 5-Asa, or Azathioprin. 14. The method of claim 1, wherein said oligonucleotide is administered topically to mucousal membranes. 15. The method of claim 1, wherein said oligonucleotide is administered intracolonically. 16. The method of claim 1, wherein said subject is elective for colectomy. 17. The method of claim 1, wherein the oligonucleotide is administered in the form of a pharmaceutical composition comprising the oligonucleotide together with one or more pharmaceutically acceptable excipient(s) and/or carrier(s). 18. The method of claim 17, wherein said composition comprises said oligonucleotide and water.

Details for Patent 9,795,627

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2031-11-25