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Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT THERAPEUTICS
INITIATES THIRD PHASE III TRIAL OF CORLUX®
MENLO PARK, Calif.
(May 4, 2005) -- Corcept Therapeutics Incorporated (NASDAQ: CORT)
today announced that it has initiated its third Phase III clinical trial
designed to evaluate the safety and efficacy of CORLUX® (mifepristone)
for the treatment of the psychotic features of psychotic major depression
(PMD). CORLUX has been granted Fast Track designation for this indication.
Corcept anticipates having initial results from this study available by
the end of 2006. Results from the company's two ongoing Phase III trials
are expected to be reported during the first half of 2006.
"We are pleased
to have begun the third Phase III trial for our lead development program,"
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 are investigating whether CORLUX provides rapid and
sustained relief from the psychotic symptoms of this severe illness."
Clinical Trial
Design
The primary endpoint for this randomized, double-blind, placebo-controlled
Phase III clinical trial of CORLUX, known as Corcept 09, is the proportion
of patients with at least a 50% improvement in the Brief Psychiatric Rating
Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28. A
secondary endpoint is a 50% or greater improvement in BPRS PSS at both
Day 7 and Day 56, which is identical to the primary endpoints of the company's
other two ongoing Phase III studies. 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. In all three trials, patients
must have at least mild psychotic symptoms (BPRS PSS = 12) to enter the
studies and will be hospitalized if clinically necessary. BPRS PSS assessments
will also be made at Days 14, 28 and 42.
Corcept 09 is the company's first study to be conducted in Europe. This
study will enroll up to 280 patients at approximately 15 sites in Croatia,
Bulgaria and Serbia with a randomized one-to-one distribution into either
a CORLUX or a placebo arm. Patients will receive either 600 mg of CORLUX
or placebo once daily for a period of seven days. Concurrent with the
first day of dosing, all patients will receive antidepressant therapy
through Day 56. No patient will be allowed to take either antidepressant
or antipsychotic medication for at least one week before beginning the
seven day treatment period. Treatment with antipsychotic medications or
electroconvulsive therapy will not be allowed at any time during the study.
Previously completed
trials
The Company has completed four studies of CORLUX for the treatment of
psychotic features of PMD. In January 2001, a dose finding clinical trial
evaluating the efficacy, tolerability and dose response of CORLUX 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. Based on
these encouraging results, the Company conducted two clinical trials,
the 02 study and 03 study, which were double-blind, placebo-controlled
safety and efficacy studies in which a total of 429 patients were enrolled.
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
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 PMD. The drug is administered orally to PMD patients once per day for
seven days. CORLUX, a potent GR-II antagonist, appears to mitigate the
effects of the elevated and abnormal release patterns of cortisol seen
in PMD. For additional information about the company, please visit www.corcept.com.
Forward Looking
Statements
Statements made in this news release, other than statements of historical
fact, are forward-looking statements, including, for example, statements
relating to our PMD clinical development program, FDA agreements and the
completion of Phase III trials. Forward-looking statements are subject
to a number of known and unknown risks and uncertainties which might cause
actual results to differ materially from those expressed or implied by
such statements. For example, there can be no assurances with respect
to the, efficacy, safety, completion or success of clinical trials, there
can be no assurances with respect to the regulatory process or regulatory
approvals, there can be no assurances with respect to commercial success,
and trial timetables may not be accurate. Risk factors are set forth in
the Company's SEC filings, all of which are available from our website
(www.corcept.com) or from the SEC's website (www.sec.gov). We disclaim
any intention or duty to update any forward-looking statement made in
this news release.
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