Corcept Therapeutics Presents Results of Clinical Study at the 59th Annual Society of Biological Psychiatry Conference
2004-05-03 07:30 (New York)
MENLO PARK, Calif., May 3 /PRNewswire-FirstCall/ -- Corcept Therapeutics
Incorporated (Nasdaq: CORT) today announced that Dr. Joseph Belanoff,
Corcept's chief executive officer, presented the results of the Corcept '03
clinical study investigating the use of its lead drug, CORLUX(TM)
(mifepristone) for the treatment of psychotic features of psychotic major
depression (PMD) at the Biological Psychiatry Conference in New York City on
May 1. The results of this study demonstrated with statistical significance
that more patients treated with CORLUX achieved a rapid and sustained
reduction of the psychotic features of PMD than did patients treated with
placebo.
The '03 study 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 '03 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 < .05). The BPRS is an 18-item rating instrument used to
assess psychopathology.
Additionally, 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 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 were the most symptomatic (score greater than 12 on the BPRS PSS)
and who received CORLUX separated with even greater statistical significance
from those who received placebo.
The results of the '03 study also indicated that CORLUX was well tolerated
as demonstrated by the finding that there was no statistically significant
difference in adverse events observed between the CORLUX group and the placebo
group.
"We are pleased with the results of this study because a seven day course
of treatment with CORLUX appeared to produce a substantial and sustained
reduction in psychotic symptoms in patients with PMD," said Dr. Belanoff.
"Currently, the most effective treatment for PMD is electroconvulsive therapy
(ECT), often referred to as electric shock therapy. The vast majority of
patients with PMD choose not to have this therapy. Instead patients often opt
for a combination of antidepressant and antipsychotic medications, which are
slow acting and have many significant side effects."
"Given the results of our '03 study, we expect to begin pivotal Phase III
trials very soon. These studies are designed to replicate the results of the
'03 study. Upon successful completion of these trials, we expect to submit an
NDA 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 engaged in
the development of drugs for the treatment of severe psychiatric and
neurological diseases. Corcept's lead product candidate, CORLUX, is currently
in Phase III clinical trials for the treatment of the psychotic features of
psychotic major depression. CORLUX is an oral medication being developed for
patients with PMD to be administered once a day in a controlled setting, such
as a hospital or physician's office. CORLUX is a potent GR-II antagonist that
appears to mitigate the effects of the elevated and abnormal release patterns
of cortisol in PMD patients. Corcept is also conducting a clinical trial to
evaluate the safety and efficacy of our drug in improving cognition in
patients with mild to moderate Alzheimer's disease.
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. |
