-- Study Design: Six groups (n = 12 per group) of rats were allowed to
eat a normal diet for 56 days. Five groups were dosed orally with
olanzapine daily. The sixth group received placebo. At day 35, the five
groups receiving olanzapine had gained a statistically significant amount
of weight compared to the group receiving placebo. The five olanzapine
groups then began to receive daily oral doses either of CORT 108297 (at one
of three dose levels), CORLUX, or placebo through day 56.
-- Results: The rats administered olanzapine alone continued to gain
weight through day 56. In contrast, the rats given olanzapine along with
CORT 108297 and those administered olanzapine with CORLUX did not. By day
56, there was a highly statistically significant difference between these
groups and the group administered olanzapine alone. In addition,
olanzapine induced weight gain amelioration by CORT 108297 was dose
dependent. The rats that received the combination of olanzapine with CORT
108297, or with CORLUX, had significantly less abdominal fat than the group
dosed with olanzapine alone.
CORT 108297 Demonstrated Statistically Significant Weight Gain Prevention
-- Study Design: Six groups (n = 12 per group) of rats were allowed to
eat a normal diet for 21 days. Five groups were dosed orally with
olanzapine daily and one group was given placebo daily. Four of the groups
that received olanzapine were also dosed orally with either CORT 108297 (at
one of three dose levels) or CORLUX; one group received olanzapine plus
placebo. The sixth group was dosed with only placebo.
-- Results: At day 21, the three groups dosed with the combination of
olanzapine and CORT 108297 had gained significantly less weight compared to
the group administered olanzapine alone. Rats administered olanzapine plus
CORLUX also gained less weight than rats administered olanzapine alone, but
this result did not reach statistical significance.
Atypical Antipsychotics Are All Known to Cause 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 patients taking the following drugs:
Abilify® (aripiprazole, Bristol Myers Squibb and Otsuka American
Pharmaceutical)
Clozaril® (clozapine, Novartis)
Geodon® (ziprasidone, Pfizer)
Risperdal® (risperidone, Janssen, a unit of Johnson & Johnson)
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.
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the development of drugs for
the treatment of severe psychiatric and metabolic disorders. The company
has two Phase 3 programs ongoing; CORLUX for the treatment of the psychotic
depression and for Cushing's Syndrome.
Corcept has also developed an extensive intellectual property portfolio
that covers the use of GRII antagonists in the treatment of a wide variety
of psychiatric and metabolic disorders, including the prevention of weight
gain caused by the use of antipsychotic medication. The company has also
discovered and filed patents for the three different series of compounds
which block cortisol's activity at the GRII receptor but do not block the
progesterone receptor. CORT 108297, a potential lead compound from these
series, recently produced encouraging results in a human microdosing
study. The compound was extremely well absorbed, demonstrated good
bioavailability and had a half-life that appears compatible with once-a-day
oral dosing. Corcept retains worldwide commercial rights to CORT 108297 as
well as all additional compounds within the three series.
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 and research programs.
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 cost, rate of
spending, completion or success of clinical trials; financial projections
may not be accurate; there can be no assurances that Corcept will pursue
further activities with respect to the development of CORLUX, CORT 108297,
or any of its other selective GR-II antagonists. 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: Caroline Loewy Chief Financial Officer Corcept Therapeutics 650-688-8783 www.corcept.com