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Patient Enrollment Completed for Phase 3 Trial of Mifepristone to Treat Psychotic Major Depression
"We recently announced that patient enrollment was completed in our first Phase 3 study, Corcept 07, and that we expect to report the results of that trial in August," said Corcept's Chief Executive Officer Joseph K. Belanoff, M.D. "In addition, we now expect to report the results from Corcept 09 in September 2006. We expect to report the results of our third Phase 3 trial, Corcept 06, in the fourth quarter."
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 manic depression. The disorder 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.
A Description of Study 09
Study 09 is a randomized, double-blind, placebo-controlled study that is being conducted in Europe. The primary endpoint is 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, a responder analysis. A secondary endpoint is the proportion of patients with at least a 50 percent improvement in the 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. Patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study. Study enrollees may be either inpatients or outpatients. BPRS PSS assessments are made at Days 14, 42 and 56.
Patients may not take any antidepressant or antipsychotic medication for at least one week before study randomization. At randomization, they are placed in a one-to-one distribution into either a treatment group or a placebo group. Patients in the treatment group receive 600 mg of CORLUX once daily for a period of seven days. All patients receive antidepressant therapy starting on Day 1 and through Day 56. Treatment with antipsychotic medications or electroconvulsive therapy at any time during the study results in the patient being classified as a non-responder.
Previously Completed Trials
The company has completed four studies of CORLUX for treating the psychotic features of PMD. In January 2001, a dose-finding clinical trial evaluated the efficacy, tolerability of and dose response to CORLUX. The results showed that after one week of treatment, approximately two-thirds of the patients in the two higher dosage groups (600 mg and 1200 mg) experienced clinically meaningful reductions in psychosis, as measured by the BPRS PSS. Based on these encouraging results, Corcept conducted two double-blind, placebo-controlled safety and efficacy clinical trials (Study 02 and Study 03) in which a total of 429 patients were enrolled.
Study 02 indicated that CORLUX was well tolerated, and there were no discernible problems with drug interactions between CORLUX and commonly prescribed antipsychotic and antidepressant medications. Study 03 demonstrated with statistical significance that patients in the CORLUX group were more likely than patients in the placebo group to achieve a 50 percent reduction in the BPRS PSS at Day 7, sustained to Day 28. At the request of the FDA, approximately one third of the 221 patients enrolled in this study had efficacy measures taken at Day 56. Of those patients who exhibited at least mild psychotic symptoms on Day 0 (BPRS PSS greater than or equal to 12) Study 03 showed with statistical significance that patients receiving CORLUX were more likely than patients receiving placebo to achieve a 50% reduction in the BPRS PSS at day 7 sustained to day 56.
A fourth trial involved an open-label study of the safety of retreatment in patients with a favorable response to treatment in Studies 02 and 03. The results indicated that patients tolerated their retreatment well. Twenty-eight patients participated in this study.
Source: Corcept Therapeutics Incorporated