News Bulletin on Lupus Drugs on Development

August 28, 2009

Epratuzumab shows positive effects in people with lupus in Stage IIb trial

Yesterday, 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 all autoimmune dieases, 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 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