CORCEPT COMPLETES ENROLLMENT IN THIRD PHASE III CORLUX STUDY

Corcept Therapeutics has completed patient enrollment in Study 06, the third of three Phase III clinical trials in which Corlux (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression. The company expects to announce the results in late February 2007.

A total of 441 patients have been enrolled in Study 06, a randomized, double-blind, placebo-controlled trial, at 40 sites in the United States and five sites in Europe. The primary endpoint is the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both day seven and day 56. BPRS PSS assessments will be conducted at baseline and days, seven, 14, 28, 42 and 56.

Patients were evenly distributed among three active dose groups (300, 600 and 1,200 mg) or a placebo group and received once daily dosing for a period of seven days. As with Corcept's two previously completed Phase III clinical trials, Study 07 and Study 09, treatment with antipsychotic medications or electroconvulsive therapy is not be allowed at any time during this study.

In August Corcept announced that the first of the three Phase III trials of Corlux showed negative results. Study 07 revealed no meaningful separation in response between patients receiving Corlux and patients receiving placebo. In September the company announced the results of Study 09, which showed a similarly high placebo response rate.