Method and pharmaceutical composition for treating crohn's disease

Patent metadata

Field	Value
Publication number	US-2018303933-A1
Application number	US-201815951321-A
Country	US
Kind code	A1
Filing date	Apr 12, 2018
Priority date	Apr 14, 2017
Publication date	Oct 25, 2018
Grant date	—

Abstract

It is an object of the present invention to provide a pharmaceutical composition comprising an anti-fractalkine antibody that provides therapeutically effective improvement to Crohn's disease, after the administration thereof to a human subject, and a method for treating Crohn's disease. Provided is a pharmaceutical composition for treating Crohn's disease. The present pharmaceutical composition comprises an anti-fractalkine antibody and a pharmaceutically acceptable excipient, and is used, such that the anti-fractalkine antibody is intravenously administered to a human at a dose of at least 10 mg/kg of human body weight in a method for treating Crohn's disease.

First claim

1 . A method for treating Crohn's disease, comprising intravenously administering to a human in need thereof, an anti-fractalkine antibody at a dose of at least 10 mg/kg of human body weight, wherein the anti-fractalkine antibody is an antibody comprising:
a heavy chain variable region comprising the amino acid sequence shown in SEQ ID NO: 13
(QVQLVQSGAEVKKPGASVKVSCKASGYTFTNYYIHWVKQAPGQGLEWIGWIYPGDGS PKFNERFKGRTTLTADKSTNTAYMLLSSLRSEDTAVYFCATGPTDGDYFDYWGQGTTV TVSS);
a light chain variable region comprising the amino acid sequence shown in SEQ ID NO: 14

(DIQMTQSPSSLSASVGDRVTITCRASGNIHNFLAWYQQKPGKAPKLLIYNEKTLADGVP SRFSGSGSGTDYTLTISSLQPEDFATYFCQQFWSTPYTFGGGTKVEIK); and
a constant region of human IgG2 isotype, wherein
the Fc region of the constant region of human IgG2 isotype comprises mutations V234A and G237A.

2 . The method according to claim 1 , wherein the anti-fractalkine antibody is intravenously administered to a human at a dose of 10 to 15 mg/kg of human body weight.

3 . The method according to claim 1 , wherein the anti-fractalkine antibody is intravenously administered to a human in need thereof at a dose of 10 mg/kg of human body weight or 15 mg/kg of human body weight.

4 . The method according to claim 1 , characterized by intravenously administering a pharmaceutical composition, which is formulated, such that it provides a mean C max of the anti-fractalkine antibody at a dose of 1 mg/kg of human body weight that is a value of 21 to 25 μg/mL.

5 . The method according to claim 1 , characterized by intravenously administering a pharmaceutical composition, which is formulated, such that when the anti-fractalkine antibody is administered to a human by single-dose intravenous administration at a dose of 10 mg/kg of human body weight, it provides a mean C max of the anti-fractalkine antibody that is a value included in the numerical range of 80% to 125% of 2.4×10 2 μg/mL.

6 . The method according to claim 1 , characterized by intravenously administering a pharmaceutical composition, which is formulated, such that when the anti-fractalkine antibody is administered to a human by single-dose intravenous administration at a dose of 10 mg/kg of human body weight, it provides a mean AUC (0-t) of the anti-fractalkine antibody that is a value included in the numerical range of 80% to 125% of 7.0×10 4 μg·h/mL.

7 . The method according to claim 1 , characterized by intravenously administering a pharmaceutical composition, which is formulated, such that when the anti-fractalkine antibody is administered to a human by single-dose intravenous administration at a dose of 10 mg/kg of human body weight, it provides a mean AUC (0-336h) of the anti-fractalkine antibody that is a value included in the numerical range of 80% to 125% of 3.8×10 4 μg·h/mL.

8 . The method according to claim 1 , which comprises multiple-dose intravenous administration of the anti-fractalkine antibody at dosing intervals from once every week to once every two weeks.

9 . The method according to claim 1 , which comprises intravenous administration of the anti-fractalkine antibody, such that the mean trough concentration of the anti-fractalkine antibody is 80 μg/mL or more.

10 - 19 . (canceled)

Assignees

• Eisai R&D Man Co Ltd

Inventors

• Yasuda Nobuyuki
• Oketani Kiyoshi
• Baba Hiroko
• Nakano Tomohisa
• Mori Masahiko

Classifications

• A61K9/0019

  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 title

• A61P1/00 Primary

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K39/3955 Primary

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• C07K16/24

  against cytokines, lymphokines or interferons · CPC title