TAbS







Briakinumab Terminated Naked monospecific

Antibody Information

Entry ID 1779
INN Briakinumab
Status Terminated
Drug code(s) ABT-874, Ozespa
Brand name None
mAb sequence source mAb human
General Molecular Category Naked monospecific
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG1
Light chain isotype lambda
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) IL-12/23 p40
Indications of clinical studies Crohn's disease, psoriasis, multiple sclerosis
Primary therapeutic area Immune-mediated / inflammatory disorders

Development stage information


Most advanced stage of development (global) Terminated at regulatory review
Status Inactive
Start of clinical phase (IND filing or first Phase 1) July 01, 2000
Start of Phase 2 April 15, 2004
Start of Phase 3 February 15, 2008
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company AbbVie
Licensee/Partner Cambridge Antibody Technology
Comments about company or candidate Abbott is developing ABT-874 as a potential treatment for Crohn's disease, psoriasis and multiple sclerosis. As of Nov 2005, A Phase II clinical trial continues in multiple sclerosis. As of November 2009, Phase III clinical trials for plaque psoriasis and a Phase II trial for multiple sclerosis have been completed, and a Phase II trial for Crohn's disease is underway. On January 15, 2011, Abbott announced the withdrawal of its application to the US FDA and European regulators for briakinumab (Ozespa). Following feedback from regulatory authorities indicating the need for further analysis, including the potential for additional studies, Abbott withdrew its applications and was evaluating next steps including possible resubmission at a later date. This compound has never been resubmitted for approval.
Full address of company North Chicago, Illinois, United States
North America
United States of America
https://www.abbvie.com/

Description/comment

ABT-874 is a fully human anti-IL12 monoclonal antibody, isolated and optimised by CAT in collaboration with Abbott, and licensed to Abbott. Immunoglobulin G1, anti-(human interleukin-12 subunit beta (IL-12 subunit p40, CLMF p40 or NKSF2)); human monoclonal gamma1 heavy chain (218-216')-disulfide with human monoclonal gamma light chain, dimer (224-224'':227-227'')-bisdisulfide

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None