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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
www.corcept.com
CORCEPT
THERAPEUTICS COMPLETES ENROLLMENT IN PHASE 3 STUDY
FOR TREATING PSYCHOTIC MAJOR DEPRESSION
MENLO PARK, Calif.,
(May 1, 2006) -- 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 = 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 = 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.
Forward-looking Statements
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.
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