New Study Findings Represent a Critical Step Forward for People with Lupus

November 2, 2009

Positive Clinical Trial Results Just Announced

Findings from the BLISS-76 Phase III clinical trial of BENLYSTA™ (belimumab) represent an important milestone in the development of new therapeutic options for patients with systemic lupus erythematosus

Today, Human Genome Sciences (HGS) and their partner GlaxoSmithKline (GSK) released very encouraging new results from a second Phase III trial, BLISS-76, of its investigational lupus drug BENLYSTA™ (belimumab).  In the study, BENLYSTA met its primary efficacy endpoint of superiority versus placebo after 52 weeks. 

BENLYSTA also met the primary endpoint in the first of the two pivotal Phase III trials, BLISS-52.  The Phase III development program for BENLYSTA is the largest clinical trial program ever conducted in lupus patients.   

“The Alliance for Lupus Research (ALR) is thrilled with the successful completion of the second Phase III study of a potential new lupus drug,” explains Barbara Boyts, President of the Alliance for Lupus Research.  “The Bliss-76 trial represents a critical step forward for people with lupus everywhere.  Our hope is that the success of this trial will support the FDA approval of the first new drug for lupus in 50 years.”

BENLYSTA specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS^®, a naturally occurring protein that promotes the development of B-lymphocyte cells into mature plasma cells in systemic lupus erythematosus.  Plasma cells are a type of white blood cell that normally produces antibodies, an important component of the body’s defense against infection.  In autoimmune diseases such as lupus, elevated levels of BLyS are believed to contribute to the production of auto-antibodies that attack and destroy the body’s own healthy tissues, causing the inflammation that is a characteristic of the disease.  Previous clinical studies have suggested that BENLYSTA can reduce auto-antibody levels.  Now, the results of the Phase III trials suggest that BENLYSTA can also reduce disease activity.   

The BLISS-76 study is ongoing for 24 more weeks.  Additional trial data will be available at the conclusion of the study period.  HGS and GSK are expected to submit marketing applications for regulatory approval in the United States, Europe and other regions in the first half of 2010.  If approved, BENLYSTA will be the first in a new class of drugs called BLyS-specific inhibitors.

More Than 10 Years of Significant Research Supported

The Alliance for Lupus Research supported some of the important basic and translational research on the molecule targeted by BENLYSTA, BLyS, also called B cell-activating factor (BAFF).  Research conducted by Dr. William Stohl at the University of Southern California and Dr. Robert Carter, currently the Deputy Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, established BLyS/BAFF as a potential therapeutic target for patients with systemic lupus erythematosus.  Their research, funded through the ALR Target Identification in Lupus Program, along with research by many other committed immunologists and lupus investigators, set the stage for clinical development programs and clinical trials that are now resulting in documented decreases in lupus disease activity.  The ALR has funded more than five million dollars in B-cell research in the past ten years.

“The Alliance for Lupus Research remains committed to supporting the important research that will ultimately lead to a detailed understanding of this most complex autoimmune disease,” says Mary K. Crow, M.D., the Alliance for Lupus Research’s Scientific Advisory Board Chair.  “The diverse research funding programs developed by the Organization, including its International Systemic Lupus Erythematosus Genetics (SLEGEN) Consortium and its Functional Genomics and Genetic Pathways grants, along with the Target Identification in Lupus grants, are helping to identify other drug targets like BLyS that may ultimately contribute to the development of additional targeted therapies. These research efforts, along with the steadfast commitment of lupus patients who participate in important clinical trials, will result in new therapeutic options that lead to better patient outcomes.”