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.
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