Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1824 |
| INN | Brazikumab |
| Status | Terminated |
| Drug code(s) | AMG 139, MEDI2070 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Trangenic mouse (Xenomouse platform) |
| Target(s) | IL-23p19 |
| Indications of clinical studies | Ulcerative colitis, psoriasis, Crohn's Disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2010 |
| Start of Phase 2 | February 15, 2013 |
| Start of Phase 3 | December 07, 2018 |
| 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 | Amgen |
| Licensee/Partner | AstraZeneca, AbbVie |
| Comments about company or candidate | June 1, 2023: AstraZeneca announced the discontinuation of the brazikumab inflammatory bowel disease (IBD) development programme, an anti-IL-23 monoclonal antibody, being investigated for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve. NCT03961815 Phase 3 started in Jan 2020. NCT03759288 Phase 2/3 in Crohn's disease/IBD sponsored by AZ still recruiting as of last update in Feb 2023. Jan 2020: AbbVie and Allergan announced that Allergan has entered into definitive agreements to divest brazikumab (IL-23 inhibitor) and Zenpep (pancrelipase). These agreements are in conjunction with the ongoing regulatory approval process for AbbVie's acquisition of Allergan. AstraZeneca will acquire brazikumab, an investigational IL-23 inhibitor in Phase IIb/III development for Crohn's Disease and in Phase II development for ulcerative colitis, including global development and commercial rights. June 2019: AbbVie and Allergan announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie's common stock of $78.45 on June 24, 2019. The transaction is expected to close in early 2020. NCT03961815 Phase 3 study in CD enrolling by invitation as of Sep, 2019. NCT03759288 Phase 2/3 study in Crohn's disease started in December 2018. NCT03616821 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis started Aug 7, 2018. NCT02574637 Phase 2 study in Crohn disease terminated in Feb 2018. Data from the Phase IIa study of brazikumab for the treatment of Crohn's disease were published in Gastroenterology in an article entitled "Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn’s Disease: A Phase 2a Study" on April 5, 2017. Rights granted to Allergan in Oct 2016. NCT01714726 Phase 2 completed. NCT01258205 Phase 1 study active not recruiting as of June 2014 |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
MEDI2070 (formerly known as AMG 139) is a human immunoglobulin G2 monoclonal antibody that selectively binds the p19 subunit, specifically blocking binding of IL23 to its receptor (https://www.sciencedirect.com/science/article/pii/S001650851735401X)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |