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Data Demonstrates Metabolic Benefits of Adding CORLUX(R) to Treatment With Risperdal(R)
Monday, February 23, 2009 9:00 AM


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).



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