MENLO PARK, CA -- (Marketwire) -- 02/02/09 -- Corcept Therapeutics (NASDAQ: CORT) today announced positive results from a clinical study that tested whether CORLUX mitigates the weight gain associated with Risperdal. The data demonstrated 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. Risperdal, a leading antipsychotic for the treatment of schizophrenia and bipolar disorder, is marketed by Johnson & Johnson. CORLUX is Corcept's late-stage GRII receptor antagonist, which the company is also evaluating in ongoing Phase 3 trials for psychotic depression and Cushing's Syndrome.

The data announced today confirmed results previously reported from similar clinical studies of CORLUX which demonstrated statistically significant mitigation of Zyprexa associated weight gain.

"We are pleased to have demonstrated that CORLUX appears to mitigate the weight gain associated with Risperdal as it mitigated the weight gain associated with Zyprexa. This study provides evidence that the benefits of GRII antagonism are not limited to concurrent use with Zyprexa and may, in fact, be applicable to the broad class of antipsychotics," said Dr. Robert L. Roe, M.D., President of Corcept. "The use of GRII antagonists to prevent weight gain 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."

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 and a range of metabolic parameters were measured.

Results: 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). Additional metabolic parameters, including fasting insulin, triglycerides and abdominal fat, are being analyzed. Consistent with prior studies, CORLUX appeared to be well tolerated.

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 seen in many patients.