The preliminary analysis of Genelabs Technologies' phase III clinical trial, Study GL02-01, for its investigational lupus drug Prestara (prasterone) indicated that the study failed to meet its primary endpoint. This double-blind, placebo controlled clinical trial was designed to measure the effect of Prestara on the bone mineral density of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids, Genelabs said in a release.

The company plans to continue its analysis of the data from Study GL02-01 and will seek to meet with the US FDA to determine its next steps.

"Although these preliminary results show that this study failed to reach statistical significance, we are continuing to analyze the data in order to gain further understanding of the results," stated James A.D. Smith, president and CEO. "This process typically takes some time, and I regret that we will likely not have further information to provide on Prestara until we have completed these steps," he added.

Genelabs previously completed a one-year phase III clinical trial, designated Study GL95-02, which included a nested study that indicated that the group of patients receiving Prestara had increased bone mineral density, compared to a decrease in bone density for the group of patients on placebo. Based on these results, the FDA issued Genelabs an approvable letter, the key contingency of which was a further clinical trial to confirm these results. Study GL02-01 was designed to generate data to confirm the Study GL95-02 bone mineral density results.