Press Release
CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
IR@corcept.com
CORCEPT PRECLINICAL TRIALS SHOW CORLUX® PREVENTS WEIGHT GAIN ASSOCIATED WITH USE OF OLANZAPINE, THE ACTIVE INGREDIENT IN ZYPREXA®
Menlo Park, Calif., (April 18, 2005) -- Corcept Therapeutics, Incorporated
(NASDAQ: CORT) today announced results from two preclinical studies evaluating
whether CORLUX® can (i) induce weight loss following olanzapine (the
active ingredient in Zyprexa®) induced weight gain and (ii) prevent
the weight gain induced by olanzapine. These studies were conducted in
a rat model of olanzapine induced weight gain. The studies show that CORLUX
has the potential to both reduce the weight gain caused by olanzapine
and to prevent the weight gain caused by the initiation of treatment with
olanzapine.
"We are encouraged by these preclinical results", said Dr. Robert
L. Roe, M.D., President of Corcept. "The use of GRII antagonists
to prevent the weight gain commonly associated with the use of many antipsychotic
drugs could be of great benefit to the millions of people currently taking
these medications. Because findings in animal studies do not always translate
into human experience, we look forward to testing our hypothesis in patients".
THE WEIGHT LOSS
STUDY
In the first
study, four groups (n = 12 per group) of rats were allowed to eat a normal
diet for eight weeks. Three of these groups were dosed orally with olanzapine
for the eight weeks of the study. The fourth group received placebo for
the eight weeks. At Day 35 the three groups receiving olanzapine had gained
a statistically significant amount of weight compared to the group receiving
placebo. The three olanzapine groups then began to receive daily oral
doses of CORLUX through Day 56. Each group was assigned a different dose.
The rats receiving the combination of olanzapine and CORLUX lost a statistically
significant amount of weight from day 35 to day 42. At each assessment
point between day 42 and day 56, there was no statistically significant
difference in weight between the rats receiving the combination of olanzapine
and CORLUX and the rats in the control group. In addition, the rats that
received the combination of olanzapine and CORLUX developed no more abdominal
fat than the control group.
THE WEIGHT GAIN
PREVENTION STUDY
In the second
study four groups (n = 12 per group) of rats were allowed to eat a normal
diet and were dosed orally with olanzapine for the three weeks of the
study. Three of these groups were also dosed orally with CORLUX, each
group receiving a different dose level. The fourth group was dosed with
placebo in addition to olanzapine. At Day 21, the three groups dosed with
the combination of olanzapine and CORLUX had gained significantly less
weight compared to the group fed olanzapine plus placebo. In addition,
the groups that received olanzapine and CORLUX developed significantly
less abdominal fat than the group that received olanzapine plus placebo.
THE LABELS OF
ATYPICAL ANTIPSYCHOTICS CURRENTLY CONTAIN A WARNING REGARDING WEIGHT GAIN
The labels
of the following atypical antipsychotic class drugs contain a warning
for hyperglycemia and diabetes mellitus, both associated with the weight
gain seen in many patents taking these drugs:
Abilify® (aripiprazole,
Bristol Myers Squibb and Otsuka American Pharmaceutical)
Clozaril® (clozapine, Novartis)
Geodon® (ziprasidone, Pfizer)
Risperdal® (risperidone, Janssen)
Seroquel® (quetiapine, AstraZeneca)
Zyprexa® (olanzapine, Eli Lilly).
Despite their side effect profile, atypical antipsychotic medications are widely prescribed throughout the world because of their efficacy.
INTELLECTUAL PROPERTY
PORTFOLIO
Corcept's
primary activity continues to be the development of CORLUX, for the treatment
of the psychotic symptoms of psychotic major depression (PMD). Other metabolic
and psychiatric diseases may be effectively treated by GR-II antagonists
like CORLUX and the company has developed an extensive intellectual property
portfolio to cover the treatment of these diseases, including the prevention
of weight gain caused by the use of antipsychotic medications. Corcept
is also conducting a Phase II clinical trial of CORLUX as a cognitive
enhancer in early Alzheimer's disease. The company has also discovered
and filed patents for GR-II specific compounds that do not block the progesterone
receptor. "Eventually, we hope to test and develop our new GR-II
compounds in a wide variety of disorders," said Joseph K. Belanoff,
M.D., Corcept's Chief Executive Officer.
ABOUT CORCEPT THERAPEUTICS,
INCORPORATED
Corcept
Therapeutics Incorporated is a pharmaceutical company engaged in the development
of drugs for the treatment of severe psychiatric and neurological diseases.
Corcept's lead product, CORLUX, is currently in Phase III clinical trials
for the treatment of 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 mitigate the effects of the elevated and abnormal
release patterns of cortisol seen in PMD. 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 our preclinical and clinical development programs, and the
expected timing of the initiation or results of our clinical 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 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; there can be no assurance that the results
of clinical trials will be consistent with preclinical studies; there
can be no assurance that results obtained with olanzapine can be replicated
with any other drug; there can be no assurance with respect to the regulatory
process or regulatory approvals; and there can be no assurance with respect
to commercial success. 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.