MENLO PARK, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Corcept Therapeutics Incorporated announced today that it completed patient enrollment in Study 06, the third of three Phase 3 clinical trials in which CORLUX(R) (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression (PMD). 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 5 sites in Europe. The primary endpoint 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 7 and Day 56. The BPRS is an 18-item rating instrument used to assess psychopathology and the PSS includes the four items in the BPRS that specifically measure psychosis. BPRS assessments will be conducted at baseline and Days, 7, 14, 28, 42 and 56. Patients must have at least mild psychotic symptoms (BPRS PSS > or = 12) to enter the studies and will be hospitalized if clinically necessary.
Patients were evenly distributed among three active dose groups (300 mg, 600 mg and 1200 mg) or a placebo group and patients received once daily dosing for a period of seven days. All patients in the study must not have taken any antidepressant or antipsychotic medication for at least one week before the seven-day treatment period. All patients receive antidepressant therapy starting on Day 1 through Day 56. As with Corcept’s two previously completed Phase 3 clinical trials evaluating CORLUX for the treatment of PMD, Study 07 and Study 09, treatment with antipsychotic medications or electroconvulsive therapy is not be allowed at any time during this study.
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects about three million people in the United States every year. It is more prevalent than either schizophrenia or bipolar I disorder. PMD is characterized by severe depression accompanied by delusions, hallucinations or both. People with PMD are approximately 70 times more likely to commit suicide than the general population and often require lengthy and expensive hospital stays. There is no FDA-approved treatment for PMD.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company focused on developing drugs for treating severe psychiatric and neurological diseases. Corcept’s lead product, CORLUX, is in Phase 3 clinical trials for treating the psychotic features of PMD. The drug is administered orally to PMD patients once per day for seven days. CORLUX, a potent GR-II antagonist, appears to reduce the effects of the elevated and abnormal release patterns of cortisol seen in PMD. The company has also initiated a proof-of-concept study to evaluate the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. For more information, please visit www.corcept.com.
Forward-looking Statements
Statements made in this news release -- other than statements of historical fact -- are forward-looking statements. These include information relating to Corcept’s PMD clinical development program, FDA agreements, and the timing of the completion of pivotal Phase 3 trials. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied here. For example, there can be no assurances on the efficacy, safety, completion or success of clinical trials; the regulatory process or regulatory approvals, or commercial success. In addition, trial timetables may not be accurate. Risk factors are explained in the company’s SEC filings, all of which are available from its Web site (www.corcept.com) or from the SEC’s Web site (www.sec.gov). The company does not have any intention or duty to update forward-looking statements made in this news release.
Corcept Therapeutics Incorporated
CONTACT: Fred Kurland, Chief Financial Officer, Corcept Therapeutics,+1-650-327-3270, or IR@corcept.com
Web site: http://www.corcept.com/
