Contact Information: CONTACT: Joseph Belanoff Chief Executive Officer Corcept Therapeutics 650-327-3270 www.corcept.com
Corcept Therapeutics Announces Commencement of Next Phase 3 Study With CORLUX(R) for the Treatment of Psychotic Depression
Agreement Signed With MedAvante, Inc.
| Source: Corcept Therapeutics
MENLO PARK, CA--(Marketwire - March 24, 2008) - Corcept Therapeutics (NASDAQ : CORT ) today
announced the commencement of its fourth Phase 3 trial, Study 14,
evaluating CORLUX for the treatment of the psychotic features of psychotic
depression. This trial is a randomized, double-blinded, placebo-controlled
study which will enroll up to 450 patients at approximately 25 sites in the
United States. In connection with this study Corcept also announced the
signing of an agreement with MedAvante, Inc., a provider of centralized
clinical rating services.
The Study 14 protocol incorporates learnings from the three most recently
completed Phase 3 trials. Based on confirmation of a correlation between
the amount of drug in a patient's blood and the likelihood that the patient
will respond to treatment, this study will use a CORLUX dose of 1200 mg
once per day for seven days. The study's primary endpoint will be a
comparison of the number of patients who meet response criteria at both
days 7 and 56, as has been used in Corcept's previous studies of psychotic
depression. MedAvante's centralized rating services are expected to
increase the accuracy, reliability, and quality of the psychiatric
assessments. A review of past studies has also led to refinement of
clinical site selection.
MedAvante will provide centralized psychometric assessments via high
resolution video-conferencing. Robert L. Roe, MD, Corcept's President,
commented, "We are very excited about MedAvante providing the expert
centralized rating services. Reducing inter-rater variability will
increase our study's power to detect a difference between CORLUX and
placebo."
Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept, said, "We
look forward to working with MedAvante in our new study. We are hopeful
that the combination of an increased dose and the use of centralized
ratings will allow us to definitively determine the efficacy of CORLUX in
the treatment of the psychotic features of psychotic depression."
Given the serious nature of psychotic depression the United States Food and
Drug Administration, or FDA, has granted a fast-track designation for
CORLUX for the treatment of the psychotic features of psychotic depression.
In addition, the FDA has indicated that CORLUX will receive a priority
review if no other treatment is approved for psychotic depression at the
time Corcept submits its New Drug Application.
About Psychotic Depression
Psychotic depression 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 psychotic depression 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 psychotic depression.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in
the development of GR-II antagonist 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 and Cushing's Syndrome. The Company is
also engaged in preparation for clinical trials to evaluate CORLUX for the
management of weight gain induced by antipsychotic medications and
continued development work on its proprietary, selective GR-II antagonists.
For additional information about the company, please visit www.corcept.com.
About MedAvante
MedAvante has pioneered and commercialized a solution that addresses one of
the global pharmaceutical industry's most intractable problems: the high
rate of uninformative or failed studies. MedAvante provides centralized
expert psychological rater services to the pharmaceutical industry using
unique methods to systematically remove potential sources of bias and
variability from the assessment process. By centralizing assessments with
expert, standardized, objective, blinded clinical interviewers over
MedAvante's 2 way real-time high quality video-conferencing, MedAvante's
Expert Centralized Ratings makes subjective measures of determining drug
efficacy increasingly objective. As a result, pharmaceutical sponsors can
increase study power, reduce trial failure rates, and get better CNS drugs
to market sooner in the patent protected period. In the last three years
MedAvante has administered 10,000 remote expert assessments to over 200
research sites for Phase 2 and Phase 3 large Pharma CNS studies. For
additional information, please visit www.MedAvante.net.
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, and the ability of MedAvante's services to increase the accuracy,
reliability, and quality of the psychiatric assessments in the new Phase 3
trial. 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 completion or
success of clinical trials; and there can be no assurances that Corcept
will pursue further activities with respect to the 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.