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Methods of administering beta7 integrin antagonists

A technology of integrins and antagonists, applied in the fields of anti-inflammatory agents, immunoglobulins, chemical instruments and methods, etc., can solve problems such as inconvenience of patients

Inactive Publication Date: 2014-02-26
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A limitation of vedolizumab therapy is that it is administered intravenously, which can be inconvenient for the patient and can also be associated with unwanted or adverse events such as infusion site reactions

Method used

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  • Methods of administering beta7 integrin antagonists
  • Methods of administering beta7 integrin antagonists
  • Methods of administering beta7 integrin antagonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0249] Phase I, Phase I, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAbβ7 Administered in a Single-Dose, Dose-Escalation Phase Followed by a Multiple-Dose, Parallel Treatment Phase in Ulcerative Colitis Patients Multicenter, randomized, placebo-controlled, double-blind study

[0250] research description

[0251] Description of rhuMAbβ7 (etrolizumab)

[0252] rhuMAbβ7 (etrolizumab) is a humanized monoclonal antibody based on human IgG1 subclass III V H , κ subtype-IV L Consensus sequence, and specificity against the β7 subunit of integrin heterodimers. It has been shown to bind α4β7 with high affinity (K of about 116 pM d ) and αEβ7 (K about 1800pM d ).

[0253] This recombinant antibody has two heavy chains (446 residues) and two light chains (214 residues) covalently linked by interchain and intrachain disulfide bonds typical of IgG1 antibodies. For the studies described here, it was produced in Chi...

Embodiment 2

[0347] A phase II, randomized, double-blind, placebo-controlled study and an open-label extension study evaluating the efficacy and safety of rhumab beta7 in patients with moderate to severe ulcerative colitis

[0348] Research design

[0349] research description

[0350] This Phase II study is a randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two rhumab beta7 dose levels compared to placebo in patients with moderate to severe UC. This target patient population is the same as that studied in the Phase I study above. The primary efficacy endpoint will be assessed at Week 10 (2 weeks after the last dose of study drug) and the secondary efficacy endpoint will be assessed at Week 6.

[0351] rhuMAbβ7 100 mg SC (fixed dose) at Weeks 0, 4 and 8 and 420 mg SC at Week 0 (flat loading dose) followed by 300 mg SC or matching placebo SC at Weeks 2, 4 and 8 within a dose range of 1:1: Patients were randomized in a ratio of 1. Researc...

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Abstract

Methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohns disease are provided. Also provided are methods of administering integrin beta7 antagonists, such as anti-beta7 antibodies. In addition, particular dosing regimens, including dosing regimens comprising subcutaneous administration and administration using self-inject devices are provided.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to Provisional US Application No. 61 / 470,360, filed March 31, 2011, and Provisional US Application No. 61 / 550,216, filed October 21, 2011, both of which are hereby incorporated by reference in their entireties. [0003] sequence listing [0004] This application contains a Sequence Listing that has been submitted in ASCII format via EFS-Web, which is hereby incorporated by reference in its entirety. This ASCII copy, created on March 15, 2012, is named P4622R1WO_SequenceListing.txt and is 17,964 bytes in size. technical field [0005] Methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of administering integrin β7 antagonists, such as anti-β7 antibodies. In addition, specific dosing regimens are provided, including dosing regimens involving subcutaneous ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P1/04C07K16/00
CPCC07K16/2839A61K2039/545C07K2317/92A61K2039/54A61K2039/505C07K2317/24A61K2039/55A61P1/00A61P1/04A61P29/00A61P37/00A61K31/196A61K31/519A61K31/52A61K39/3955
Inventor B·阿南德S·奥伯恩E·斯特法尼奇M·唐J·维施M·威廉姆斯
Owner F HOFFMANN LA ROCHE & CO AG
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