NEW YORK (AP) | Human Genome Sciences and GlaxoSmithKline said Monday that their experimental lupus treatment passed another key goal on its path to potentially becoming the first new drug for the disease in decades.
Shares of Human Genome Sciences soared 35 percent with the report.
Wall Street and researchers anticipated study data from the trial, hoping it would confirm positive results from a prior late-stage study. The drug, Benlysta, is aimed at suppressing the immune system’s response to lupus, which is an inflammatory disease prompting the body to attack its own tissue and organs.
The anticipated study data, from a clinical program called Bliss-76, showed a 10-milligram dose of Benlysta, plus therapy with steroids, prompted an improvement in 43 percent of patients, compared with an improvement in 33 percent of patients given a placebo during the study.
“The Bliss-76 results confirm our view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,” said Human Genome President and Chief Executive Officer H. Thomas Watkins, in a statement. “We take great pride in the innovation and scientific rigor that has made it possible to bring Benlysta to this point.
Human Genome of Rockville, Md., and GlaxoSmithKline, based in the United Kingdom, plan to seek Food and Drug Administration regulatory approval in the first half of next year.
Bliss-76 involved 865 patients and took place over 52 weeks. It is the second late-stage study of the potential lupus treatment to meet key goals. Last month, the company reported similar positive results from Bliss-52, which involved at least 860 patients in Asia, South America and Eastern Europe.
Leerink Swann Research analyst Joseph P. Schwartz reaffirmed an “outperform” rating for Human Genome, saying he expects Benlysta to gain regulatory approval and then reach the market by the second half of 2010. He boosted his fair-value outlook for the stock to $40 from $30. He expects the company to present full results from Bliss-76 in the spring at a medical conference.
Shares of Human Genome Sciences rose $6.59, or 35 percent, to $25.28 in Nasdaq Stock Market composite trading. Earlier the stock traded at $26.21, its highest level since February 2002.
U.S.-listed shares of GlaxoSmithKline fell 45 cents to $40.71.
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