Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) said Tuesday that results from the first of two pivotal phase 3 trials of Benlysta in seropositive patients with systemic lupus erythematosus, or SLE, showed statistically significant improvement in patient response rate when compared with placebo.
The data from the study, named BLISS-52, demonstrated that Benlysta, or belimumab, plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. The data will be presented in Philadelphia today at the seventy-third Annual Scientific Meeting of the American College of Rheumatology.
In the BLISS-52 study, Benlysta significantly reduced SLE disease activity, disease flare rates and fatigue; significantly delayed time-to-first SLE disease flare; reduced prednisone use and improved health-related patient quality of life, the companies said.
The results also showed that improvement in patient response rate was generally consistent across subgroups. Belimumab was generally well tolerated, with rates of overall adverse events, serious adverse events, infections and fatalities comparable between belimumab and placebo treatment groups.
SLE is a chronic, autoimmune disease, in which the immune system attacks the body's cells and tissue, resulting in inflammation and tissue damage. Approximately 1.5 million people in the US suffer from various forms of lupus, including SLE. No new drug for lupus has been approved by regulatory authorities in more than 50 years.
Benlysta is a fully human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-Lymphocyte stimulator (BLyS). In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies.
Belimumab is being developed under a Special Protocol Assessment, which is a declaration from the FDA that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. In August 2006, Human Genome and GSK entered into a co-development and commercialization agreement for belimumab.
Results from BLISS-76, the second phase 3 trial of belimumab, are expected on November 2. If positive, Human Genome and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.
BLISS-52 was a 52- week study that randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76, a 76 week study, enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe.
The primary efficacy endpoint of both the Phase 3 development programs is to evaluate patient response rate based on the SLE Responder Index, to achieve clinically important reduction in SLE disease activity.
Among other drugs being developed for SLE, Immunomedics, Inc. (IMMU) is developing UCB's epratuzumab and Wyeth developing SBI-087 of Trubion Pharmaceuticals, Inc. (TRBN).
Monday, HGSI closed regular trading at $20.87 on the Nasdaq and GSK closed at $41.91, on the NYSE.
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