|
Press Release CONTACT:
CORCEPT THERAPEUTICS RECEIVES SPECIAL PROTOCOL ASSESSMENT FROM FDA FOR TWO PIVOTAL PHASE III TRIALS OF CORLUX MENLO PARK, Calif. (Aug. 30, 2004) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of two pivotal Phase III clinical trials evaluating CORLUX (mifepristone) for the treatment of the psychotic features of psychotic major depression (PMD). The Company plans on initiating the first of these trials immediately and expects the second to commence in the fourth quarter of 2004. Corcept anticipates having initial results from these studies available in the first half of 2006. CORLUX has been granted Fast Track designation for this indication. "We are pleased to have reached agreement with the FDA on the design of these two pivotal trials and are excited to begin," said Dr. Joseph K. Belanoff, Corcept's chief executive officer. "PMD is a disorder that affects approximately three million people in the United States each year and for which there are no FDA-approved treatments. We look forward to determining the efficacy and safety of CORLUX. Through these studies, we will investigate whether CORLUX will provide rapid and sustained relief from the psychotic symptoms of this crippling illness." Clinical Trial
Design "In our interactions with the FDA, we have discussed various potential primary endpoints to demonstrate that CORLUX provides a rapid and sustained response. In our previously completed Corcept 03 trial, we measured responses at Day 7 sustained to Day 28 and continued to measure symptom scores for about one-third of the patients through Day 56. There was a statistically significant difference between the CORLUX and placebo groups on the BPRS PSS at Day 56. Therefore, we reached agreement with the FDA to have the primary endpoint for these pivotal trials be a substantial reduction in psychotic symptoms at both Day 7 and Day 56, which will demonstrate rapid and sustained relief," commented Dr. Belanoff. The first of these trials, Corcept 07, which will begin immediately, is similar in design to the Corcept 03 trial, and will enroll up to 280 patients at approximately 20 sites in the U.S. with a randomized one-to-one distribution into either a treatment or a placebo arm. Patients in the treatment arm will receive 600 mg of CORLUX once daily for a period of seven days. All patients are to be off any antidepressant and antipsychotic medication for at least one week before beginning the seven day treatment period. After the seven days of CORLUX treatment, all patients will receive antidepressant therapy through Day 56. Treatment with antipsychotic medications or electroconvulsive therapy will not be allowed at any time during the study. The second clinical trial, Corcept 06, will enroll approximately 440 patients at about 30 sites in the U.S. These patients will be evenly distributed among three active dose groups (300 mg, 600 mg and 1200 mg) or a placebo group with patients receiving once daily dosing for a period of seven days. The three dosing levels fulfill the FDA's request to supplement data on a range of potential doses beyond that provided by our 33 patient dose ranging study completed in 2001. All patients in the study must be off any antidepressant and antipsychotic medication for at least one week before the seven day treatment period and will receive antidepressant therapy starting on Day 1 through Day 56. As with Corcept 07, treatment with antipsychotic medications or electroconvulsive therapy will not be allowed at any time during this study. Previously Completed
Trials The 02 study showed that CORLUX was well tolerated and that there were no discernible problems with drug interactions between CORLUX and commonly prescribed antipsychotic and antidepressant medications. The 03 study demonstrated with statistical significance that patients in the CORLUX group were more likely than patients in the placebo group to achieve a 50% reduction in the BPRS PSS at Day 7 sustained to Day 28. In a fourth trial, an open label study of the safety of retreatment in patients with a favorable response to treatment in the 02 and 03 studies, it was indicated that patients tolerated their retreatment well. Twenty-eight patients participated in this study. About Psychotic
Major Depression About Corcept Therapeutics
Incorporated Forward Looking
Statements
|