MENLO PARK, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Corcept Therapeutics Incorporated today announced that an article describing the results of its Study 03, a Phase 2 clinical trial that serves as the primary basis for the design of the company’s three Phase 3 trials, is available to the public at the web site of the Journal of Biological Psychiatry, at http://www.sobp.org/ .
The results of this study demonstrated with statistical significance that more patients treated with CORLUX(R) achieved a rapid and sustained reduction of the psychotic features of psychotic major depression (PMD) than did patients treated with placebo.
Study 03 was a multi-center, randomized, placebo controlled study that evaluated 600 mg of CORLUX administered once daily over a period of seven days in patients with PMD. Patients were not allowed to receive any antipsychotic or antidepressant medication for at least seven days prior to or during administration of the study drug. The study randomized 221 patients on a one- to-one basis to receive either CORLUX or placebo.
The results of this study showed that patients who received CORLUX were more likely than patients who received placebo to achieve a rapid and sustained reduction in psychosis as measured by a 30% reduction in the BPRS (Brief Psychiatric Rating Scale) at day 7 sustained to day 28. This difference was statistically significant (p value = .041). The BPRS is an 18- item rating instrument used to assess psychopathology.
Additionally, 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 positive symptom subscale (PSS) at day 7 sustained to day 28. The PSS is a validated instrument containing the four items in the BPRS that more specifically measure psychosis. The subgroup of patients who exhibited at least mild psychotic symptoms on Day 0 (score greater than or equal to 12 on the BPRS PSS), and who received CORLUX separated with even greater statistical significance from those who received placebo.
At the request of the FDA, the last third of patients enrolled in this trial were followed to 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), 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 (p value = 0.038).
The results of Study 03 also indicated that CORLUX was well tolerated. There were no statistically significant differences in adverse events observed between the CORLUX group and the placebo group.
“We based the design of all three of our Phase 3 clinical trials on the design of Study 03,” said Corcept’s Chief Executive Officer Joseph K. Belanoff, M.D. “We expect to report results from the first of these trials, Study 07, later this month. We plan to report the results of our other two Phase 3 trials, Study 09 and Study 06, in September and in the fourth quarter, respectively. We expect that these three clinical trials will be the foundation of the NDA we submit to the FDA. Because of the serious nature of PMD and the lack of approved drugs for the disorder, the FDA has granted a Fast Track designation for CORLUX for the treatment of the psychotic features of PMD,” continued Dr. Belanoff.
About Psychotic Major Depression (PMD)
PMD is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or manic-depressive illness. 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.
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.
The scientific information discussed in this news release is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for mifepristone. The product is not approved for the investigational uses discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the product for these uses. Only the FDA can determine whether the product is safe and effective for these uses.
This press release contains forward-looking statements that are based on management’s current expectations. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statement we make. There are significant risks and uncertainties in our pharmaceutical research and development, including risks relating to the commencement and success of our pivotal clinical trials, risks relating to the receipt of necessary clinical and manufacturing regulatory approvals, and risks relating to successful product commercialization. These and other risks are described in greater detail in the “Risk Factors” section of the final prospectus relating to our initial public offering, filed with the SEC. We do not assume any obligation to update any forward-looking statements.
Corcept Therapeutics Incorporated
CONTACT: Fred Kurland, Chief Financial Officer of Corcept Therapeutics,+1-650-327-3270, or IR@corcept.com
Web site: http://www.corcept.com/
