Human Genome's Plan B: Lupus Drug

With shares of Human Genome Sciences(HGSI) at an all-time low, the company's next shot at a turnaround lies with a risky phase III study of a lupus drug due in July.

The Bethesda, Md.-based biopharmaceutical firm released disappointing results from a phase III study of its hepatitis C drug Albuferon on Monday, which caused the stock price to fall 67% to 55 cents a share and remain near that level Wednesday.

Analysts who follow Human Genome Sciences say the setback with Albuferon raises the stakes for the company's other late-stage drug candidate, LymphoStat-B. Two phase III studies of LymphoStat-B in patients with systemic lupus erythematosus, or SLE, are under way, with data from the first study expected in July.

Human Genome Sciences is developing LymphoStat-B in partnership with GlaxoSmithKline(GSK).

There are no approved drugs to treat SLE, or lupus, although steroids are commonly used to treat symptoms. Recently, a drug from La Jolla Pharmaceuticals(LJPC) and BioMarin Pharmaceuticals(BMRN) was a failure in a phase III study of lupus patients. Rituxan, an otherwise wildly successful cancer and autoimmune drug for Genentech(DNA), also failed a phase III lupus study last year. A second Rituxan study in lupus is under way.

Lupus is a chronic disease in which the body's immune system attacks connective tissue, resulting in inflammation and tissue damage, often to the heart, joints, lungs and kidneys. Women are more often diagnosed with lupus than men, and the disease goes through periods where it flares up then goes into remission.

LymphoStat-B is a human monoclonal antibody designed to recognize and tamp down the biological activity of B-lymphocyte stimulator, or BLyS, a substance that was discovered by Human Genome Sciences.