Contact Information: CONTACT: Joseph K. Belanoff, M.D. Chief Executive Officer Corcept Therapeutics 650-327-3270 www.corcept.com
Corcept Therapeutics Announces Commencement of a Phase 3 Trial for CORLUX(R) for the Treatment of Endogenous Cushing's Syndrome
| Source: Corcept Therapeutics
MENLO PARK, CA--(Marketwire - December 19, 2007) - Corcept Therapeutics Incorporated (NASDAQ : CORT ) today announced the commencement of its Phase 3 trial with CORLUX for
the treatment of endogenous Cushing's Syndrome. CORLUX is a cortisol
receptor (GR-II) antagonist.
In September, the Company announced that the Food and Drug Administration
(FDA) had opened the Investigational New Drug application (IND) for CORLUX
for the treatment of endogenous Cushing's Syndrome, which allowed us to
initiate this 50-patient open label study. In the communication regarding
the opening of the IND, the FDA indicated that a single study may provide a
reasonable basis for the submission of a New Drug Application for the
treatment of endogenous Cushing's Syndrome.
In July 2007, the Company announced the receipt of Orphan Drug Designation
for CORLUX for the treatment of endogenous Cushing's Syndrome. Drugs that
receive Orphan Drug Designation obtain seven years of marketing exclusivity
from the date of drug approval as well as tax credits for clinical trial
costs, marketing application filing fee waivers and assistance from the FDA
in the drug development process.
About Cushing's Syndrome
Cushing's Syndrome is caused by prolonged exposure of the body's tissues to
high levels of the hormone cortisol. Cushing's Syndrome is relatively rare
and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of
every one million people are affected each year. Symptoms vary, but most
people have one or more of the following manifestations: High blood sugar,
high blood pressure, upper body obesity, rounded face, increased fat around
the neck, thinning arms and legs, severe fatigue and weak muscles.
Irritability, anxiety, cognitive disturbances and depression are common.
Cushing's Syndrome can affect every organ system in the body and can be
lethal if not treated effectively.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of drugs for the treatment of severe psychiatric and
metabolic diseases. Corcept's lead product, CORLUX, is currently in Phase
3 clinical trials for the treatment of the psychotic features of psychotic
depression. The drug is administered orally to psychotic depression
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 psychotic depression. In June 2007, Corcept
Therapeutics announced positive results from its proof of concept study
evaluating the ability of CORLUX to mitigate weight gain associated with
olanzapine, a commonly used antipsychotic medication. 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 the timing and results of the clinical trial for CORLUX for the
treatment of Cushing's Syndrome, Corcept's other 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
pace of enrollment, 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.