Patent application EP17157844A (EP), filed 2017-02-24
Publication number: EP3211007A1
Title: PHARMACEUTICAL COMPOSITION FOR TREATING CROHN'S DISEASE
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. 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.
IPC codes: A61K  39/    00            A I
C07K  16/    24            A I
Claims: number: 1
text: A pharmaceutical composition for treating Crohn's disease, which comprises an anti-fractalkine antibody and a pharmaceutically acceptable excipient, wherein
the anti-fractalkine antibody is an antibody comprising:
number: 2
text: The pharmaceutical composition according to claim 1, which is used, such that
the anti-fractalkine antibody is intravenously administered to a human at a dose of 10 to 15 mg/kg of human body weight.
number: 3
text: The pharmaceutical composition according to claim 1, which is used, such that
the anti-fractalkine antibody is intravenously administered to a human at a dose of 10 mg/kg of human body weight.
number: 4
text: The pharmaceutical composition according to claim 1, which is used, such that
the anti-fractalkine antibody is intravenously administered to a human at a dose of 15 mg/kg of human body weight.
number: 5
text: The pharmaceutical composition according to any one of claims 1 to 4, wherein
when administered to a human by single-dose intravenous administration, the mean C<max> of the anti-fractalkine antibody at a dose of 1 mg/kg of human body weight is 21 to 25 µg/mL.
number: 6
text: The pharmaceutical composition according to any one of claims 1 to 4, wherein
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, the mean C<max> of the anti-fractalkine antibody is a value included in the numerical range of 80% to 125% of 2.4 × 10<2> µg/mL.
number: 7
text: The pharmaceutical composition according to any one of claims 1 to 4, wherein
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, the mean AUC<(0-t)> of the anti-fractalkine antibody is a value included in the numerical range of 80% to 125% of 7.0 × 10<4> µg·h/mL.
number: 8
text: The pharmaceutical composition according to any one of claims 1 to 4, wherein
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, the mean AUC<(0-336h)> of the anti-fractalkine antibody is a value included in the numerical range of 80% to 125% of 3.8 × 10<4> µg·h/mL.
number: 9
text: The pharmaceutical composition according to any one of claims 1 to 8, which is administered by multiple-dose intravenous administration at dosing intervals from once every week to once every two weeks.
number: 10
text: The pharmaceutical composition according to any one of claims 1 to 9, which is intravenously administered, such that the mean trough concentration of the anti-fractalkine antibody is 80 µg/mL or more.
number: 11
text: A pharmaceutical composition for use in a therapeutic method of Crohn's disease, wherein
the pharmaceutical composition comprises an anti-fractalkine antibody and a pharmaceutically acceptable excipient, wherein
the therapeutic method comprises intravenously administering the anti-fractalkine antibody to a human at a dose of at least 10 mg/kg of human body weight, wherein
the anti-fractalkine antibody is an antibody comprising:
Office action: search_report, dated 2017-08-30
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: WO2011052799A1
ref_type: patent
severity: background
ref_id: - H TABUCHI ET AL: "FIRST-IN-HUMAN (FIH) STUDY OF E6011, A NOVEL HUMANIZED ANTI-FRACTALKINE (CX3CL1) MONOCLONAL ANTIBODY", ANNUAL MEETING OF THE AMERICAN-SOCIETY-FOR-CLINICAL-PHARMACOLOGY-AND-THERAPEUTICS (ASCPT); SAN DIEGO, CA, USA, vol. 99, 1 February 2016 (2016-02-01), pages s33, XP055344618
ref_type: npl
severity: background
ref_id: - TANAKA YOSHIYA ET AL: "Safety and Efficacy of E6011, an Anti-Fractalkine Monoclonal Antibody, in a First-in-Patient Phase 1/2 Study in Rheumatoid Arthritis", ARTHRITIS & RHEUMATOLOGY (HOBOKEN), JOHN WILEY & SONS, INC, US, vol. 67, no. Suppl.10, 1 October 2015 (2015-10-01), XP009193437, ISSN: 2326-5191
ref_type: npl
severity: background
ref_id: WO2011052799
ref_type: patent
severity: background
ref_id: - H TABUCHI ET AL, "FIRST-IN-HUMAN (FIH) STUDY OF E6011, A NOVEL HUMANIZED ANTI-FRACTALKINE (CX3CL1) MONOCLONAL ANTIBODY", ANNUAL MEETING OF THE AMERICAN-SOCIETY-FOR-CLINICAL-PHARMACOLOGY-AND-THERAPEUTICS (ASCPT); SAN DIEGO, CA, USA, (20160201), vol. 99, page s33, XP055344618 [I] 1-11 * the whole document *
ref_type: npl
severity: background
ref_id: - TANAKA YOSHIYA ET AL, "Safety and Efficacy of E6011, an Anti-Fractalkine Monoclonal Antibody, in a First-in-Patient Phase 1/2 Study in Rheumatoid Arthritis", ARTHRITIS & RHEUMATOLOGY (HOBOKEN), JOHN WILEY & SONS, INC, US, (20151001), vol. 67, no. Suppl.10, ISSN 2326-5191, XP009193437 [X] 1-11 * the whole document *
ref_type: npl
severity: novelty_destroying
Final disposition: pending (2017-08-30)