US 12,171,832 B2
Methods of treating ulcerative colitis
Irving H. Fox, Wellesley, MA (US); and Catherine Scholz, Woburn, MA (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Dec. 23, 2019, as Appl. No. 16/726,092.
Application 16/726,092 is a continuation of application No. 15/927,032, filed on Mar. 20, 2018, abandoned.
Application 15/927,032 is a continuation of application No. 15/214,993, filed on Jul. 20, 2016, granted, now 10,143,752, issued on Dec. 4, 2018.
Application 15/214,993 is a continuation of application No. 13/462,414, filed on May 2, 2012, abandoned.
Claims priority of provisional application 61/585,859, filed on Jan. 12, 2012.
Claims priority of provisional application 61/550,545, filed on Oct. 24, 2011.
Claims priority of provisional application 61/481,533, filed on May 2, 2011.
Prior Publication US 2020/0206353 A1, Jul. 2, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/00 (2006.01); A61K 9/00 (2006.01); A61K 9/19 (2006.01); A61K 39/395 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); C07K 16/28 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/19 (2013.01); A61K 39/39591 (2013.01); A61K 47/183 (2013.01); C07K 16/2839 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/14 (2013.01); C07K 2317/24 (2013.01); C07K 2317/565 (2013.01); C07K 2317/92 (2013.01); C07K 2317/94 (2013.01)] 12 Claims
 
1. A method for treating a human patient suffering from moderately to severely active ulcerative colitis, wherein the method comprises the steps of:
administering to a human patient suffering from moderately to severely active ulcerative colitis, an initial 300 mg dose of a humanized antibody having binding specificity for human alpha4beta7 integrin;
administering a second subsequent dose of 300 mg of the humanized antibody two weeks after the initial dose;
administering a third subsequent dose of 300 mg of the humanized antibody six weeks after the initial dose; and
administering subsequent doses of 300 mg of the humanized antibody every eight weeks after the third subsequent dose of the humanized antibody;
wherein the humanized antibody is an IgG1 isotype, comprises a light chain comprising CDRs as set forth in SEQ ID NO: 11 (CDR1), SEQ ID NO: 12 (CDR2), and SEQ ID NO: 13 (CDR3), and comprises a heavy chain comprising CDRs as set forth in SEQ ID NO: 8 (CDR1), SEQ ID NO: 9 (CDR2), and SEQ ID NO: 10 (CDR3),
wherein the human patient had an inadequate response or intolerance to azathioprine or 6-mercaptopurine over a previous 5 year period, and
wherein clinical response of moderately to severely active ulcerative colitis is achieved at 6 weeks after the initial dose, and clinical remission of moderately to severely active ulcerative colitis is achieved at 52 weeks after the initial dose in the human patient.