Prestara fails lupus Phase III

Genelabs GNLB was off $1.70 (66%) to $0.89 on 60 million shares on Tuesday after its Prestara prasterone failed to significantly improve bone mineral density versus placebo, the primary endpoint, in a Phase III trial in women with systemic lupus erythematosus (SLE). Patients in the trial (GL02-01) also were receiving glucocorticoids. The company said it will continue its data analysis and plans to meet with FDA to determine the next steps.

The trial was requested in a 2002 FDA approvable letter for the compound. In June, GNLB pulled an MAA for Prestara (known as Anastar in Europe) after EMEA presented the company with a list of questions related to the compound and said the data were "not sufficient for approval." (see BioCentury Extra, Monday June 7, 2004). ...