Lupus drug Benlysta reduces symptoms in late stage testing

Human Genome Sciences Inc. and glaxosmithkline Plc said their experimental lupus drug reduced patients’ symptoms in a yearlong study. Benlysta is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006. Lupus an autoimmune disease, is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide.

In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta(TM) plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial. Among patients who received 1 mg of Benlysta for every kilogram of body weight, the company said 51.7 percent experienced a significant improvement. Of patients who took a larger dose, 10 mg per kilogram, 57.6 percent had a significant improvement.

“This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades,” said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. “It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors.”

Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. Results of a second Phase 3 trial of Benlysta(TM), known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.

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