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 |
Target(s) | IL-12/23 p40 |
Indications of clinical studies | Crohn's disease, psoriasis, multiple sclerosis |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
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 | 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/ |
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
Anticipated events | None |
Factor(s) contributing to discontinuation | None |