Corcept Therapeutics


Company Overview

Corcept Therapeutics Incorporated (NASDAQ: CORT) is a pharmaceutical company engaged in the development of medications for the treatment of severe psychiatric and metabolic diseases. The Company’s lead product candidate, CORLUX, modulates the effect of cortisol by selectively blocking the binding of cortisol to one of its two known receptors, the GR-II receptor, also known as the Type II or GR receptor. The Company has an exclusive license from Stanford University to the patent for the use of GR-II antagonists to treat the psychotic features of psychotic depression. The Company also owns or has exclusively licensed issued patents and patent applications relating to the treatment of several disorders also believed to result from, or negatively affected by, prolonged exposure to elevated cortisol.

  • Psychotic depression. The FDA has granted ‘fast track’ status to evaluate the safety and efficacy of CORLUX for the treatment of the psychotic features of psychotic depression. Psychotic depression affects approximately three million people annually in the US. There is no FDA-approved treatment for psychotic depression. Psychiatrists currently use two approaches: electroconvulsive therapy (ECT) and combination drug therapy (simultaneous use of antidepressant and antipsychotic medications). By modifying the level and release pattern of cortisol within the human body, Corcept believes that CORLUX will be able to treat the psychotic features of psychotic depression more quickly and effectively and with fewer side effects than is possible with currently available treatments.

    Three Phase III clinical trials have been completed. The Company reported the initial results of the last Phase III trial in March 2007. This study did not achieve statistical significance with respect to the primary endpoint: 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale at Day 7 and at Day 56. However, there was a statistically significant correlation between plasma levels and clinical outcome achieved during treatment. Patients whose plasma levels rose above a predetermined threshold statistically separated from both those patients whose plasma levels were below the threshold and those patients who received a placebo. Corcept believes that the confirmation of a drug concentration threshold for efficacy will serve as a strong basis for the Company’s next Phase III study, which is planned to commence during Q1 of 2008.

  • Antipsychotic-induced Weight Gain Mitigation. In June 2007, the Company announced preliminary top-line results of its proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. The preliminary top line results indicated a statistically significant reduction in weight gain in those subjects who took olanzapine plus CORLUX compared to those who took olanzapine alone. The purpose of this study was to explore the hypothesis that GR-II antagonists would mitigate weight gain associated with atypical antipsychotic medications, such as olanzapine, risperidone, clozapine and quetiapine, which are widely used to treat schizophrenia and bipolar disorder. All medications in this group are associated with treatment emergent weight gain of varying degrees and carry a warning label relating to treatment emergent hyperglycemia and diabetes mellitus. Eli Lilly provided olanzapine and financial support for this study. Studies to confirm and expand this finding are planned for 2008.

  • Cushing’s Syndrome. In July 2007, Corcept received Orphan Drug Designation from the FDA for CORLUX for the treatment of Cushing’s Syndrome - a disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol. ‘Orphan’ drugs obtain seven years of marketing exclusivity from the date of approval, as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.

In September 2007, the Company received notification that the FDA has opened the Investigational New Drug application (IND) for CORLUX for the treatment of Cushing’s Syndrome. The FDA has indicated that a single study may provide a reasonable basis for the submission of a New Drug Application (NDA) for this indication. Corcept expects to open the trial for enrollment late in Q4 of 2007.

In addition to the above, Corcept also owns or has exclusively licensed issued patents and patent applications relating to the treatment of several disorders that the Company believes also result from, or are negatively affected by, prolonged exposure to elevated cortisol including early dementia associated with Alzheimer’s disease, mild cognitive impairment, stress disorders and psychosis associated with cocaine addiction. The Company also has filed patent applications for additional diseases that may benefit from treatment with a drug that blocks the GR-II receptor.