Data Demonstrates Metabolic Benefits of Adding CORLUX(R) to Treatment With Risperdal(R)
MENLO PARK, CA--(Marketwire - February 23, 2009) - Corcept Therapeutics (NASDAQ: CORT) today
announced additional positive results from a clinical study that tested
whether CORLUX mitigates the weight gain and other metabolic effects
associated with Risperdal. The company previously announced top-line data
demonstrating that adding CORLUX to Risperdal treatment in healthy subjects
resulted in a statistically significant reduction in weight gain compared
to that seen in subjects receiving Risperdal alone. Analysis of key
secondary endpoints demonstrates that the addition of CORLUX to Risperdal
also results in less abdominal fat, lower fasting insulin levels and lower
triglyceride levels -- all of which were statistically significant compared
to treatment with Risperdal alone.
Risperdal, a leading antipsychotic for the treatment of schizophrenia and
bipolar disorder, is marketed by Johnson & Johnson. CORLUX is Corcept's
late-stage GR-II receptor antagonist, which the company is also evaluating
in ongoing Phase 3 trials for psychotic depression and Cushing's Syndrome.
The data announced today demonstrated benefits of adding CORLUX to
treatment with Risperdal, beyond the mitigation of weight gain. The
results from this study confirmed results previously reported from a
similar clinical study of CORLUX when added to treatment with Zyprexa,
which demonstrated statistically significant mitigation of
Zyprexa-associated weight gain, as well as a favorable impact on metabolic
"We are pleased to have demonstrated that not only does CORLUX appear to
mitigate the weight gain associated with Risperdal, it also has a positive
impact on metabolic markers that are commonly associated with increased
morbidity and mortality," said Dr. Robert L. Roe, M.D., President of
Corcept. "The use of GR-II antagonists to prevent the broad range of
adverse effects commonly associated with the use of many antipsychotic
drugs could provide a significant health and quality of life benefit to the
millions of people currently taking these medications."
"Data from proof of concept studies of CORLUX like those announced today
provide valuable support for development of our next-generation
GR-II receptor antagonists. The company plans to advance its lead
GR-II receptor antagonist, CORT 108297, into clinical trials in the next 12
months," said Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept
Study Design: The study was a four-week randomized double-blind controlled
study in 75 lean, healthy men (body mass index of 23 or less). Subjects
were randomized to receive either Risperdal plus placebo (n=30), Risperdal
plus CORLUX (n=30) or CORLUX plus placebo (n=15). Daily weights were
recorded, as well as abdominal fat (as measured by waist circumference),
fasting insulin, and triglycerides.
Results: As previously reported, subjects in the Risperdal alone group
gained an average of 9.2 pounds, compared to a gain of 5.1 pounds in the
Risperdal plus CORLUX group. This difference was highly statistically
significant (p < 0.0001). Today we announced that the increase in
abdominal fat (as measured by waist circumference) was 3.57 cm in the
Risperdal alone group, compared to 2.03 cm in the Risperdal plus CORLUX
group (p < 0.05). Fasting insulin increased by 10.97 mU/L in the Risperdal
alone group, compared to 1.80 mU/L in the Risperdal plus CORLUX group (p <
0.05). In addition, triglycerides increased by 30.57 mg/dL in the
Risperdal alone group, compared to an increase of only 3.13 mg/dL in the
Risperdal plus CORLUX group (p < 0.01).
Atypical Antipsychotics Are All Known to Cause Weight Gain
The labels of the class of medications known as atypical antipsychotics
contain a warning for hyperglycemia and diabetes mellitus, both associated
with the weight gain and related metabolic effects seen in many patients.
These medications are:
Abilify® (aripiprazole, Bristol Myers Squibb and Otsuka American
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.
Next-Generation GRII Antagonists Demonstrated Weight Gain Mitigation in
Corcept has also discovered and filed patents for three additional series
of compounds which, similar to CORLUX, block cortisol's activity at the
GRII receptor, but unlike CORLUX, do not block the progesterone receptor.
The company recently announced that CORT 108297, a potential lead compound
from these series, demonstrated prevention and reversal of Zyprexa®
(olanzapine) associated weight gain in two preclinical studies. 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.
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.
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.