Human Genome Drug Effective Against Lupus

Updated with stock information

Human Genome Sciences (HGSI) has beaten lupus.

The Rockville, Md.-based drugmaker announced Monday that its experimental drug Benlysta achieved a clinically and statistically significant improvement in disease response compared with placebo, according to results from a pivotal phase III study of lupus patients.

If confirmed in a second phase III study due later this year, Benlysta likely will become the first new drug approved to treat lupus specifically in 50 years. Human Genome is partnered with GlaxoSmithKline (GSK) for Benlysta's development and marketing.

The success of the Benlysta study is a signal achievement for Human Genome Sciences, placing the company on the path toward its first blockbuster product.

Human Genome shares were up 218.4% to $10.57 in Monday morning trading.

Study Results Should Surprise Many

The Benlysta win is also a bit of a surprise given the intractable nature of lupus -- a complex and hard-to-treat autoimmune disease with a notorious reputation as a drug development graveyard. For this reason and others, nearly all of the analysts covering Human Genome predicted Benlysta would fail.

They were wrong.

Human Genome reported that 57.6% of lupus patients responded to treatment with a high dose of Benlysta compared with 43.6% of lupus patients treated with a placebo. A lower dose of Benlysta also was tested, and it too demonstrated an improvement in disease response over placebo. The results were statistically significant.

The phase III study, known as BLISS-52, enrolled 852 patients with active lupus and treated them with Benlysta or a placebo for one year, making this the largest clinical trial ever conducted in lupus patients.

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