Corcept Therapeutics Inc. Announces Negative Results From Phase 3 Studies Evaluating CORLUX(R)

MENLO PARK, Calif., Sept. 29 -- Corcept Therapeutics Incorporated (Nasdaq: CORT - News), today announced that the second of its three Phase 3 trials evaluating CORLUX for treating the psychotic features of Psychotic Major Depression (PMD) was negative.

Study 09 was a randomized, double-blind, placebo-controlled study. 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 28. Specifically, the BPRS is an 18-item rating instrument used to assess psychopathology, and the PSS is a subset of four items in the BPRS that specifically measure psychosis. The study revealed no meaningful separation in response between patients receiving CORLUX and patients receiving placebo. The two key secondary endpoints of Study 09 were similarly negative.

"As was the case in Study 07, our previously announced Phase 3 clinical trial, there was an unusually high placebo response rate in Study 09," noted Robert L. Roe, M.D., Corcept's President and head of Development. "At Day 56, for example, approximately 95 percent of the patients in both of the arms of the study were responders as measured by a 50 percent improvement in BPRS PSS score."

"Although not the primary or a key secondary endpoint, it is interesting to note that there was a statistically significant separation between the CORLUX and placebo groups on an endpoint commonly used to measure the efficacy of antipsychotic and antidepressant medications, change from baseline to study end, in this case, Day 56," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. "However, because of the already high degree of response in the placebo group, it is difficult to determine how much additional clinical utility is conferred by this finding."

Corcept now has one Phase 3 study in progress. "We continue to enroll patients in Study 06 and expect to announce the results of this trial early next year," said Dr. Belanoff.


I will update more late, very busy today at my research bench. Monkey blood anyone?

CORT:NASDAQ is down 28% today trading at .95 cents.