Full Press Release Details
MENLO PARK, CA--(Marketwire - 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
"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
Eli Lilly and Company supported this proof of concept clinical study
through an Investigator Initiated Trial grant and provided olanzapine for
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.
Contact Information: CONTACT:
Joseph K. Belanoff, M.D.
Chief Executive Officer
Corcept Therapeutics