HGS Provides Positive Results For Clinical Trial Of Lupus Drug

Human Genome Sciences has announced the positive long-term Phase-II trial data for Benlysta (belimumab, formerly LymphoStat-B) in patients with active systemic lupus erythematosus.

Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS.

Phase-II continuation data demonstrates sustained improvement in disease activity and patient response rate through four years of Benlysta therapy.

The results were presented in Copenhagen at the 2009 Congress of the European League Against Rheumatism (EULAR).

William Freimuth, Vice President of Clinical Research at Human Genome Sciences, said: “We are encouraged by the sustained improvement in serologically active SLE patients treated with belimumab through four years.”

“We are also encouraged by the safety data presented at EULAR. The incidence rates per 100 patient years of all adverse event categories, including serious adverse events, overall adverse events, and serious infections were similar for belimumab and placebo during the 52-week double-blind period, and remained the same or decreased over four years of continuous treatment. Belimumab could represent a significant advance in the treatment of SLE if Phase 2 results are confirmed in the Phase 3 trials that are currently ongoing,” he added.