Epratuzumab shows positive effects on people with lupus in Stage IIb trial
Late last week, two biopharmaceutical companies, UCB and Immunomedics,
announced promising results of their phase IIb study for epratuzumab,
their drug in development for treating systemic lupus erythematosus
(SLE, or lupus). This is hopeful news for all those affected by this
autoimmune disease.
Epratuzumab, developed by Immunomedics and licensed to UCB in 2006 for
possible treatment of autoimmune diseases, is a humanized anti-CD22
monoclonal antibody with the potential to modulate B cell activity.
Although the exact role of CD22 in autoimmunity is not fully
understood, it is considered to be a negative regulator of B cell
function.
B cells are known to contribute to lupus by producing antibodies
against the body's own cells and tissues, causing the immune system to
turn on itself and resulting in the inflammation and tissue damage
that are the hallmarks of lupus. UCB and Immunomedic's released trial
results showed that the treatment advantage of epratuzumab over a
placebo reached 24.9% at week 12.
WHAT THIS MEANS FOR PEOPLE WITH LUPUS:
UCB will better understand how to design a potential phase III trial
studying many more patients. The results of the phase IIb study will
help give UCB researchers confidence in determining best dosage and
frequency when the larger scale clinical trial is designed. Very
basically, this trial gives UCB researchers useful data for moving
epratuzumab further down the clinical pipeline, giving people with
lupus another glimmer of hope for a potential new therapy for the
disease.
As Anna Novotney Barry, UCB's Clinical Program Director said, "This
12-week study was specifically aimed at identifying the best dose of
epratuzumab, dosing regimen, and primary efficacy endpoint to take
forward to the larger phase III confirmatory trials. We are delighted
to report these positive results, which have provided essential data
which create the foundation for our planned phase III clinical
program."
This promising news about epratuzumab was made possible in part
through your support of the Alliance for Lupus Research (ALR).
The ALR has strongly supported B-cell inhibition and depletion
research, going back to some of our very first grants funded, now
nearly ten years ago. Since inception, the ALR has funded almost
$5-million in the area of B-cell research.
"Among the research efforts of many lupus investigators and along with
support from many generous donors and funding sources, the research
projects funded by the ALR have had a particular emphasis on control
of B cells. These positive new data add to our growing sense that this
B cell research is bearing fruit. We will watch for future results
from epratuzumab studies with great interest."
- Mary K. Crow, M.D., Chair, ALR Scientific Advisory Board
About the ALR: The Alliance for Lupus Research (ALR) is the
world's largest charitable funder of lupus research. 100% of all
donations to the ALR support innovative medical research focused on
preventing, treating, and curing Systemic Lupus Erythematosus (SLE) or
lupus because the ALR's Board of Directors funds all
administrative and fundraising expenses. For more information, please visit
www.lupusresearch.org.
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