Healthcare Industry News: schizophrenia
News Release - May 1, 2006
Corcept Therapeutics Completes Enrollment in Phase 3 Study for Treating Psychotic Major DepressionManagement Will Host a Conference Call and Live Webcast on May 2
MENLO PARK, Calif., May 1 (HSMN NewsFeed) -- Corcept Therapeutics Incorporated (Nasdaq: CORT ) announced today it completed patient enrollment in Study 07, one of three Phase 3 clinical trials in which CORLUX® (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression (PMD). This trial is covered by a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA).
"Completing the enrollment in Study 07 is a significant milestone in our clinical program," said Corcept's Chief Executive Officer Joseph K. Belanoff, M.D. "We expect to report the results from this trial in August 2006. We also plan to report the results of our other two Phase 3 trials, Corcept 09 and Corcept 06, in the third and fourth quarters, respectively."
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 07
Study 07 is a randomized, double-blind, placebo-controlled study. 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 56, a responder analysis. Specifically, 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 had at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study and will be hospitalized if clinically necessary. BPRS PSS assessments also will be made at Days 14, 28 and 42.
Patients may not have taken 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. After a week of CORLUX or placebo, all patients receive antidepressant therapy 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 (score greater than or equal to 12 on the BPRS PSS) the 03 study 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.
Special Protocol Assessments (SPA)
The SPA is a process that provides for an official FDA evaluation of Phase 3 clinical study protocols. The SPA provides trial sponsors with a binding written agreement that the design and analysis of a study is adequate to support a license application submission, if the study is performed according to the SPA and the results are positive. The SPA agreement may only be changed by the sponsor company or the FDA by a written agreement, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.
Conference Call and Live Webcast on May 2, 2006
Management will host a conference call on May 2, 2006 at 11:00 a.m. EDT to provide an update on its PMD clinical program. To participate, please dial 866-249-6463 for domestic calls or 303-262-2004 for international calls. A telephone replay will also be available by dialing 800-405-2236 for domestic calls or 303-590-3000 for international calls. The access code is 11060051. The replay will be available until 4:00 p.m. EDT on May 9, 2006.
A live webcast of the conference call can be accessed at www.corcept.com. The event will be archived and available for replay until 4:00 p.m. EDT on May 16, 2006.
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.
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; commercial success; in addition, financial projections and 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.
Source: Corcept Therapeutics
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