Human Genome's LymphoStat-B reduced lupus disease activity in phase 2 study

By Lisa Kerner

Charlotte, N.C., June 22 - Human Genome Sciences, Inc. said a phase 2 clinical trial demonstrated that LymphoStat-B (belimumab) significantly reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE).

In addition, the human monoclonal antibody exhibited clinically relevant bioactivity and was safe and well-tolerated.

A total of 449 patients with SLE were randomized to receive one of three different doses of LymphoStat-B or a placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week period, in addition to standard-of-care therapy.

"The substantial evidence now available from our phase 2 clinical program clearly supports the phase 3 study of LymphoStat-B in patients with systemic lupus erythematosus," executive vice president of drug development David C. Stump said in a company news release.

The results will also guide the design of the phase 3 trial that Human Genome and its collaborator, GlaxoSmithKline, expect to begin in 2006, officials said.

The study results were presented at the European League Against Rheumatism 2006 Annual Congress in Amsterdam, the Netherlands.

Human Genome, based in Rockville, Md., discovers, develops, manufactures and markets protein and antibody drugs.

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