Briakinumab (ABT-874) is a human

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

being developed by

Abbott Laboratories Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, in the United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate k ...

for the treatment of

rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects synovial joint, joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and h ...

inflammatory bowel disease Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine, with Crohn's disease and ulcerative colitis (UC) being the principal types. Crohn's disease affects the small intestine and large intestine ...

, and

multiple sclerosis Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...

. As of 2011

drug development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...

for

psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by patches of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small localized patches to complete b ...

has been discontinued in the U.S. and Europe. Like

ustekinumab Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, Psoriasis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23. ...

, the antibody targets the

interleukin Interleukins (ILs) are a group of cytokines (secreted proteins and signal molecules) that are expressed and secreted by white blood cells (leukocytes) as well as some other body cells. The human genome encodes more than 50 interleukins and related ...

s 12 and 23.

Discovery

The candidate drug was discovered by

Cambridge Antibody Technology Cambridge Antibody Technology Group Plc, (commonly referred to as CAT) was a biotechnology company headquartered in Cambridge, England. Its core focus was on antibody therapeutics, primarily using phage display, Phage Display and ribosome displ ...

in collaboration with Abbott.

Trials

, Phase III

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

s for plaque psoriasis and a Phase II trial for multiple sclerosis have been completed, and a Phase II trial for

Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea, fever, abdominal distension, and weight loss. Complications outside of the ...

is underway. Briakinumab was compared to

etanercept Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. ...

and

placebo A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials ...

in several

double-blind In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...

trials. The Psoriasis Area Severity Index (PASI) was reduced significantly better than under the comparator treatments. 81–82% of patients under briakinumab, 40–56% under etanercept, and 7% under placebo reached PASI reduction of at least 75%. No head-to-head studies against ustekinumab, the other IL-12/23 inhibitor, are available. On January 15, 2011, Abbott announced the withdrawal of its application to the US FDA and European regulators for briakinumab. 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.

Royalties

This is the second candidate from a deal with Cambridge Antibody Technology that Abbott have taken to late-stage clinical trials. As a result of the protracted royalty dispute over

Humira Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's ...

Abbott agreed to pay CAT a reduced royalty of 4.75% on any future sales of ABT-874, from which CAT will pay a portion to the MRC and other licensors (according to CAT's 1997 agreement with the MRC).

References

Immunosuppressants Abandoned drugs Drugs developed by AbbVie {{antineoplastic-drug-stub