Glaxo, HGS Begin Study of Lupus Drug

U.S. biotech firm Human Genome Sciences and British drug giant GlaxoSmithKline said they’ve begun a trial of LymphoStat-B for Lupus.

The companies said dosing has begun in the trial dubbed BLISS-76, one of a pair of phase 3 trials of the new treatment in patients with active systemic lupus erythematosus (SLE).

The two multi-center, phase 3 superiority trials will evaluate LymphoStat-B plus standard of care versus placebo plus standard of care.

The first study, BLISS-76, will last 76 weeks, with data analyzed after 52 weeks in support of a potential filing for approval by the Food and Drug Administration.

The second trial, BLISS-52, will last 52 weeks and is expected to begin in the first half of 2007, the companies said.

We believe that LymphoStat-B could address the significant medical need of patients suffering from SLE, and advancing this novel therapeutic antibody to phase 3 clinical trials is a major step toward that goal, said H. Thomas Watkins, HGS’s president and chief executive officer.

The companies entered into a development deal on LymphoStat-B in August 2006.