MENLO PARK, CA -- (Marketwire) -- 02/23/09 -- 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
markers.
"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
selective
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
Therapeutics.
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).