Genelabs' Stock Drops As Lupus Drug Stalls

A Phase III trial of Genelabs Technologies' GL701(dehydroepiandrosterone; DHEA) for systemic lupus erythematosus has not achieved statistical significance when all patients are included in the analysis, because of an unusually high response rate to placebo in patients with low or no disease activity. The company's share price dropped by a third on the day of the announcement.

Lupus patients have abnormally-low levels of DHEA, and studies have shown that hormonal influences may play a role in the development and progression of the disease. Many SLE patients use steroids such as prednisone to control their symptoms, but protracted use of these drugs can be associated with severe complications.

The Phase III trial was designed to see if patients using GL701 could lower their steroid doses and still maintain stable or reduced disease activity. In the study, 191 patients with mild-to-moderate SLE who were taking between 10mg and 30mg prednisone daily received either a placebo, 100mg GL701 or 200mg GL701 daily for seven to nine months. Steroid levels were reduced over the course of the study, as long as disease activity had not worsened.