CORCEPT'S CORLUX MISSES MAIN ENDPOINT IN THIRD STUDY

Corcept Therapeutics announced that Study 06, the last of three Phase III trials evaluating Corlux for treating the psychotic features of psychotic major depression, did not achieve statistical significance with respect to its primary endpoint. However, there was a statistically significant correlation between plasma levels and clinical outcome achieved during treatment. Further, the company reported that the incidence of serious adverse events did not differ between placebo and any of the three Corlux dose groups.

Patients whose plasma levels rose above a predetermined threshold statistically separated from both those whose plasma levels were below the threshold and those patients who received placebo. This confirmed a similar finding in Study 07, another Phase III trial of Corlux completed last year.

Study 06 was a randomized, double-blind, placebo-controlled study in which 443 patients were enrolled at 45 sites in the U.S. and Europe. The primary endpoint, a responder analysis, was the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale at both day seven and day 56. As in the previous two studies, Study 07 and Study 09, the response rate in patients who received Corlux exceeded the response rate in patients who received placebo but not with statistical significance.

"We believe that the confirmation of a drug concentration threshold for efficacy as well as other observations from Study 06 and the company's two recently completed Phase III clinical trials will serve as a strong basis for the company's next Phase III study," Robert Roe, Corcept's president, said. "In the upcoming trial, which is planned to commence later in 2007, we expect to use a dose level of 1,200 mg once per day for seven days because, in Study 06, 80 percent of the patients achieved a drug plasma level sufficient for a strong clinical response at that dose."