Corcept initiates third phase III Corlux trial

The primary endpoint for this Corlux (mifepristone) phase III trial, known as Corcept 09, is the proportion of patients with at least a 50% improvement in the brief psychiatric rating scale positive symptom subscale (BPRS PSS) at both day seven and day 28.

A secondary endpoint is a 50% or greater improvement in BPRS PSS at both day seven and day 56, which is identical to the primary endpoints of the company’s other two ongoing phase III studies.

Corcept 09 is the company’s first study to be conducted in Europe. This study will enroll up to 280 patients at approximately 15 sites in Croatia, Bulgaria and Serbia with a randomized one-to-one distribution into either a Corlux or a placebo arm.

Corcept has completed four studies of Corlux for the treatment of psychotic features of psychotic major depression. In January 2001, a dose-finding clinical trial showed that after one week of treatment, approximately two-thirds of the patients in higher dosage groups experienced clinically meaningful reductions in psychosis. Other studies showed the treatment to be well-tolerated and efficient compared to placebo.

Corcept anticipates having initial results from the third phase III study available by the end of 2006, with results from the two ongoing phase III trials expected to be reported during the first half of 2006.