UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report (Date of earliest event
reported): March 19, 2007
Corcept
Therapeutics Incorporated
(Exact
name of registrant as specified in its charter)
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Delaware
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000-50679
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77-0487658
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(State
or other jurisdiction of incorporation)
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(Commission
File
Number)
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(I.R.S.
Employer Identification No.)
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149
Commonwealth Drive
Menlo
Park, CA 94025
(Address
of principal executive offices, with zip code)
(650)
327-3270
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
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Item
8.01
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Other
Events.
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On
March
19, 2007 Corcept Therapeutics Incorporated issued a press release announcing
that Study 06, the last of three Phase 3 trials evaluating CORLUX® for treating
the psychotic features of Psychotic Major Depression, did not achieve
statistical significance with respect to its primary endpoint.
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Item
9.01
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Financial
Statements and Exhibits.
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Exhibit
99.1 Press Release dated March 19, 2007
-2-
SIGNATURES
Pursuant
to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused this report
to
be signed on its behalf by the undersigned hereunto duly
authorized.
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CORCEPT
THERAPEUTICS INCORPORATED
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Date: March
23, 2007
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By:
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/s/
Fred Kurland
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Fred Kurland | |
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Chief Financial Officer | |
-3-
Exhibit
Index
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Exhibit
No.
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Description
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Study
06 Results
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-4-
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CONTACT:
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Fred
Kurland
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Chief
Financial Officer
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Corcept
Therapeutics
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650-327-3270
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IR@corcept.comwww.corcept.com
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CORCEPT
THERAPEUTICS ANNOUNCES PHASE 3 STUDY EVALUATING CORLUX® FOR PSYCHOTIC
MAJOR
DEPRESSION MISSES PRIMARY ENDPOINT
STATISTICALLY
SIGNIFICANT CORRELATION BETWEEN PLASMA LEVELS AND CLINICAL OUTCOME ACHIEVED
DURING TREATMENT
Management
will host a conference call and live webcast on March 20, 2007 at 9:00 a.m.
EDT
MENLO
PARK, Calif., March 19, 2007 – Corcept Therapeutics Incorporated
(NASDAQ: CORT), today announced that Study 06, the last of three Phase 3 trials
evaluating CORLUX for treating the psychotic features of Psychotic Major
Depression (PMD), did not achieve statistical significance with respect to
its
primary endpoint. However, there was a statistically significant correlation
between plasma levels and clinical outcome achieved during treatment. Further,
the company reported that the incidence of serious adverse events did not differ
between placebo and any of the three CORLUX dose groups.
Patients
whose plasma levels rose above a predetermined threshold statistically separated
from both those whose plasma levels were below the threshold and those patients
who received placebo. This confirmed a similar finding in Study 07, another
Phase 3 trial testing CORLUX for PMD completed in 2006.
“While
we
are disappointed that the trial did not meet the primary endpoint, we are
particularly encouraged to have met the important predefined threshold
concentration endpoint with statistical significance,” said Joseph K. Belanoff,
M.D., Corcept’s Chief Executive Officer. “This study confirms our previous
observation that at higher plasma levels the drug candidate is able to
demonstrate desired clinical effects. In particular, those patients in Study
06
who achieved a predetermined level of 1661 nanograms of CORLUX per milliliter
of
plasma separated from the placebo group with statistical
significance.”
Commenting
on these results, Ned H. Kalin, M.D., Hedberg Professor and Chair of the
Department of Psychiatry at the University of Wisconsin, said “The correlation
between plasma levels of drug and response rates found in this trial is very
exciting. The results of this study show that when psychotically depressed
patients achieve a threshold concentration of CORLUX in their system, a rapid
and sustained clinical response is likely. This is a strong demonstration of
a
drug effect in an illness that is potentially devastating and difficult to
treat.” Dr. Kalin is a member of Corcept’s Scientific Advisory
Board.
Next
Phase 3 Clinical Trial Being Planned
Robert
L.
Roe, M.D., Corcept’s President said, “We believe that the confirmation of a drug
concentration threshold for efficacy as well as other observations from Study
06
and the company’s two recently completed Phase 3 clinical trials will serve as a
strong basis for the company’s next Phase 3 study. In the upcoming trial which
is planned to commence later in 2007, we expect to use a dose level of 1200
mg
once per day for seven days because, in Study 06, 80% of the patients achieved
a
drug plasma level sufficient for a strong clinical response at that dose. In
our
initial review of a summary of the safety data, we have seen no difference
between any of the dose levels used in Study 06. We believe that this change
in
dose as well as other modifications to the protocol should allow us to
definitively demonstrate the efficacy of CORLUX in the treatment of the
psychotic features of PMD.”
About
Study 06
Study
06
was a randomized, double-blind, placebo-controlled study in which 443 patients
were enrolled at 45 sites in the United States and Europe. The primary endpoint,
a responder analysis, was 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. Specifically, the BPRS is an 18-item rating
instrument used to assess psychopathology, and the PSS is a subset of four
items
in the BPRS that specifically measure psychosis. Patients were evenly
distributed among three active dose groups (300 mg, 600 mg and 1200 mg) or
a
placebo group, with patients receiving once daily dosing for a period of seven
days. All patients in the study were off any antidepressant and
antipsychotic medication for at least one week before the seven day treatment
period and received concomitant antidepressant therapy starting on Day 1 through
Day 56. As was the case with the company’s two previously completed Phase 3
studies evaluating CORLUX for PMD, treatment with antipsychotic medications
or
electroconvulsive therapy was not allowed at any time during this study. In
Corcept’s previous Phase 3 studies, as in Study 06, the response rate in
patients who received CORLUX exceeded the response rate in patients who received
placebo but not with statistical significance.
Conference
Call and Live Webcast on March 20, 2007
Management
will host a conference call on March 20, 2007 at 9:00 a.m. EDT to provide an
update on its PMD clinical program. To participate, please dial
866-297-6394 for domestic calls or 847-944-7315 for international calls. A
telephone replay will also be available by dialing 877-213-9653 for domestic
calls or 630-652-3041 for international calls. The access code is
17309243#. The replay will be available until 4:00 p.m. EDT on April 3,
2007.
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 April 3, 2007.
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.
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 and the timing of the completion of
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, enrollment completion or success
of clinical trials; the regulatory process or regulatory approvals; commercial
success; in addition, 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.