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Corcept Therapeutics Announces Phase 3 Study Evaluating Corlux for,Psychotic Major Depression Misses Primary Endpoint

consin, said “The correlation between plasma levels of drug and response rates found in this trial is very exciting. The results of this study show that when psychotically depressed patients achieve a threshold concentration of CORLUX in their system, a rapid and sustained clinical response is likely. This is a strong demonstration of a drug effect in an illness that is potentially devastating and difficult to treat.” Dr. Kalin is a member of Corcept’s Scientific Advisory Board.

Next Phase 3 Clinical Trial Being Planned

Robert L. Roe, M.D., Corcept’s President said, “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 3 clinical trials will serve as a strong basis for the company’s next Phase 3 study. In the upcoming trial which is planned to commence later in 2007, we expect to use a dose level of 1200 mg once per day for seven days because, in Study 06, 80% of the patients achieved a drug plasma level sufficient for a strong clinical response at that dose. In our initial review of a summary of the safety data, we have seen no difference between any of the dose levels used in Study 06. We believe that this change in dose as well as other modifications to the protocol should allow us to definitively demonstrate the efficacy of CORLUX in the treatment of the psychotic features of PMD.”

About Study 06

Study 06 was a randomized, double-blind, placebo-controlled study in which 443 patients were enrolled at 45 sites in the United States 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 (BPRS PSS) at both Day 7 and Day 56. Specifically, the BPRS is an 18-item rating instrument used to assess psychopathology, and the PSS is a subset of four ite
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