Human Genome Sciences (HGS) and co-development partner, GlaxoSmithKline, announced promising data from a Phase III trial with the systemic lupus erythematosus (SLE) candidate, Benlysta™. HGS’ stock price more than tripled from $3.32 at the close of Friday to open trading today at $10.90.
Data from the year-long BLISS-52 study showed that compared to placebo, treatment using Benlysta allowed patients to reduce their steroid intake. It also resulted in improvements in overall disease activity without clinically significant flare-ups in one or more isolated organ.
HGS says the placebo-controlled BLISS-52 study was the largest ever to have been completed for lupus. The company adds that it was also the first Phase III study with a new biologic immune therapy against the disease to meet its primary and most of its secondary endpoint. A second, longer-term Phase III trial, BLISS-76, is due to report results later in 2009.
In July 2005, GSK exercised its option under a June 1996 agreement to co-develop and co-commercialize Benlysta, formerly called LymphoStat-B, with HGS on a worldwide basis. Under the resulting co-development and co-commercialization agreement, HGS is responsible for conducting the Phase III trials with assistance from GSK.