UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
8-K/A
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report:
June 21, 2007
(Date
of
earliest event reported)
Corcept
Therapeutics Incorporated
(Exact
name of registrant as specified in its charter)
|
Delaware
|
000-50679
|
77-0487658
|
|
(State
or other jurisdiction of incorporation or
organization)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification No.)
|
|
149
Commonwealth Drive
Menlo
Park, CA
|
94025
|
|
|
(Address
of principal executive offices)
|
(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):
|
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
¨
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
|
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
|
Explanatory
statement: This
Form
8-K/A if being filed solely for the purpose of correcting an error in the
state
of incorporation as reflected on the cover page of the Form 8-K filed on
June
21, 2007.
Item
8.01 Other Events
On
June
21, 2007 Corcept Therapeutics Incorporated issued a press release announcing
positive results from its proof of concept study evaluating the ability of
CORLUX®
to
mitigate weight gain associated with Olanzapine.
Item
9:01 Financial
Statements and Exhibits.
|
(a)
|
Financial
statements:
|
None
|
(b)
|
Pro
forma financial
information:
|
None
|
(c)
|
Shell
company transactions:
|
None
|
(d)
|
Exhibits
|
|
99.1
|
Press
Release of Corcept Therapeutics Incorporated dated June 21,
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.
| CORCEPT THERAPEUTICS INCORPORATED | ||
|
Date:
June 21, 2007
|
By:
|
/s/
Anne LeDoux
|
|
Anne
LeDoux
|
||
|
Vice
President &
Controller
|
||
-3-
Exhibit
Index
|
Exhibit
No.
|
Description
|
|
Press
Release of Corcept Therapeutics Incorporated dated June 21,
2007
|
-4-
 |
CONTACT:
Joseph
K. Belanoff, M.D.
Chief
Executive Officer
Corcept
Therapeutics
650-327-3270
IR@corcept.com
www.corcept.com
|
Corcept
Therapeutics Announces Positive Results from its Proof of Concept Study
Evaluating the Ability of CORLUX®
to Mitigate Weight Gain Associated With Olanzapine
Menlo
Park, Calif.,
(June
21, 2007) -- Corcept Therapeutics (NASDAQ:CORT) today announced that preliminary
top line results indicated a statistically significant reduction in weight
gain
in those subjects who took olanzapine plus CORLUX compared to those who took
olanzapine alone in a randomized, two week, double-blind, placebo controlled,
proof of concept study.
In
this
study, 57 lean, healthy men (body mass index of 25 or less) were randomized
to
receive either olanzapine plus placebo (n=22), olanzapine plus CORLUX (n=24)
or
CORLUX plus placebo (n=11). This study took place in an institutional setting
where daily weights were recorded and a range of metabolic parameters were
measured. In the two week study, subjects in the olanzapine alone group gained
an average of 2.5 pounds more than subjects in the olanzapine plus CORLUX group
and 2.2 pounds more than subjects in the CORLUX alone group, highly
statistically significant differences (p<.001). The difference in weight gain
trajectory was apparent in the first days of the study, reaching statistical
significance during the first week. A preliminary review also indicates that
for
those patients who experienced a rise in fasting insulin and rise in
triglycerides while taking olanzapine, the addition of CORLUX appears to have
a
beneficial effect; further analyses of these variables will be completed in
the
coming weeks. Although no unexpected study drug related adverse events were
seen
in any group, a complete review of all safety data has not yet been
completed.
The
group
of medications known as atypical antipsychotics, including olanzapine,
risperidone, clozapine and quetiapine, are widely used to treat schizophrenia
and bipolar disorder. All medications in this group are associated with
treatment emergent weight gain of varying degrees and carry a warning label
relating to treatment emergent hyperglycemia and diabetes mellitus.
"Weight
gain and alterations in metabolic efficiency have been observed for many years
in patients with abnormally high circulating cortisol. It is possible that
a
cortisol receptor antagonist like CORLUX may affect these characteristics in
patients who take atypical antipsychotic medication" said Joseph K. Belanoff,
M.D., Chief Executive Officer of Corcept. "This study begins to give us some
insight into the possible causes of weight gain associated with atypical
antipsychotic medications, and potentially may lead us towards a
treatment."
Corcept
previously announced results from two preclinical studies conducted in a rat
model of olanzapine induced weight gain. These studies demonstrated that CORLUX
reduced both the weight gain associated with ongoing olanzapine use and
prevented the weight gain associated with the initiation of treatment with
olanzapine. "Because findings in animal studies do not always translate into
human experience, we are pleased to see that the effect of CORLUX in our proof
of concept study appears to replicate the experimental animal data,” said Robert
L. Roe, M.D, President of Corcept.
-1-
Eli
Lilly
and Company supported this proof of concept clinical study through an
Investigator Initiated Trial grant and provided olanzapine for the
study.
The
combination of olanzapine and CORLUX is not approved for any indication and
Lilly has no plans to pursue the use of combination CORLUX and olanzapine
commercially. The purpose of this study was to explore the hypothesis that
GR-II
antagonists might mitigate weight gain associated with atypical antipsychotic
medications.
Intellectual
Property Portfolio
Corcept
has developed an extensive intellectual property portfolio that covers the
use
of GR-II antagonists in the treatment of severe psychotic and metabolic
disorders, including the prevention of weight gain caused by the use of
antipsychotic medications. The company has also discovered and filed patents
for
three different series of compounds which block cortisol's activity at the
GR-II
receptor but do not block the progesterone receptor. "Eventually, we hope to
test and develop our new GR-II antagonists in a wide variety of disorders
including the mitigation of weight gain associated with atypical
antipsychotics," said James N. Wilson, Chairman of the Board of
Corcept.
About
Corcept Therapeutics Incorporated
Corcept
Therapeutics Incorporated is a pharmaceutical company engaged in the development
of drugs for severe psychiatric and metabolic disorders. The company’s lead
program is the development of CORLUX for the treatment of the psychotic symptoms
of psychotic depression. For additional information about the company, please
visit www.corcept.com.
Statements
made in this news release, other than statements of historical fact, are
forward-looking statements, including, for example, statements relating to
Corcept’s clinical development programs, and its spending plans. 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 by such statements. For example, there can be no assurances with
respect to the commencement, cost, rate of spending, completion or success
of
clinical trials; financial projections may not be accurate; there can be no
assurances that the investigations for future clinical trials will be completed,
or that Corcept will pursue further activities with respect to clinical
development of CORLUX. These and other 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.
-2-