Corcept Therapeutics Completes Enrollment In Second Phase 3 Study For Treating Psychotic Major Depression
August 04, 2017
Corcept
Therapeutics Incorporated (Nasdaq: CORT) announced today that it completed
patient enrollment in Corcept 09, the second of three Phase 3 clinical
trials in which CORLUX(R) (mifepristone) is being evaluated for treating
the psychotic features of psychotic major depression (PMD).
"We recently announced that patient enrollment was completed in our
first Phase 3 study, Corcept 07, and that we expect to report the results
of that trial in August," said Corcept's Chief Executive Officer Joseph K.
Belanoff, M.D. "In addition, we now expect to report the results from
Corcept 09 in September 2006. We expect to report the results of our third
Phase 3 trial, Corcept 06, in the fourth quarter."
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects about three million
people in the United States every year. It is more prevalent than either
schizophrenia or manic depression. The disorder is characterized by severe
depression accompanied by delusions, hallucinations or both. People with
PMD are approximately 70 times more likely to commit suicide than the
general population and often require lengthy and expensive hospital stays.
There is no FDA-approved treatment for PMD.
A Description of Study 09
Study 09 is a randomized, double-blind, placebo-controlled study that
is being conducted in Europe. The primary endpoint is the proportion of
patients with at least a 50 percent improvement in the Brief Psychiatric
Rating Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28, a responder analysis. A secondary endpoint is the proportion of patients
with at least a 50 percent improvement in the BPRS PSS at both Day 7 and
Day 56. The BPRS is an 18-item rating instrument used to assess
psychopathology, and the PSS includes the four items in the BPRS that
specifically measure psychosis. Patients must have at least mild psychotic
symptoms (BPRS PSS greater than or equal to 12) to enter the study. Study
enrollees may be either inpatients or outpatients. BPRS PSS assessments are
made at Days 14, 42 and 56.
Patients may not take any antidepressant or antipsychotic medication
for at least one week before study randomization. At randomization, they
are placed in a one-to-one distribution into either a treatment group or a
placebo group. Patients in the treatment group receive 600 mg of CORLUX
once daily for a period of seven days. All patients receive antidepressant
therapy starting on Day 1 and through Day 56. Treatment with antipsychotic
medications or electroconvulsive therapy at any time during the study
results in the patient being classified as a non-responder.
Previously Completed Trials
The company has completed four studies of CORLUX for treating the
psychotic features of PMD. In January 2001, a dose-finding clinical trial
evaluated the efficacy, tolerability of and dose response to CORLUX. The
results showed that after one week of treatment, approximately two-thirds
of the patients in the two higher dosage groups (600 mg and 1200 mg)
experienced clinically meaningful reductions in psychosis, as measured by
the BPRS PSS. Based on these encouraging results, Corcept conducted two
double-blind, placebo-controlled safety and efficacy clinical trials (Study
02 and Study 03) in which a total of 429 patients were enrolled.
Study 02 indicated that CORLUX was well tolerated, and there were no
discernible problems with drug interactions between CORLUX and commonly
prescribed antipsychotic and antidepressant medications. Study 03
demonstrated with statistical significance that patients in the CORLUX
group were more likely than patients in the placebo group to achieve a 50
percent reduction in the BPRS PSS at Day 7, sustained to Day 28. At the
request of the FDA, approximately one third of the 221 patients enrolled in
this study had efficacy measures taken at Day 56. Of those patients who
exhibited at least mild psychotic symptoms on Day 0 (BPRS PSS greater than
or equal to 12) Study 03 showed with statistical significance that patients
receiving CORLUX were more likely than patients receiving placebo to
achieve a 50% reduction in the BPRS PSS at day 7 sustained to day 56.
A fourth trial involved an open-label study of the safety of
retreatment in patients with a favorable response to treatment in Studies
02 and 03. The results indicated that patients tolerated their retreatment
well. Twenty-eight patients participated in this study.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company focused
on developing drugs for treating severe psychiatric and neurological
diseases. Corcept's lead product, CORLUX, is in Phase 3 clinical trials for
treating the psychotic features of PMD. The drug is administered orally to
PMD patients once per day for seven days. CORLUX, a potent GR-II
antagonist, appears to reduce the effects of the elevated and abnormal
release patterns of cortisol seen in PMD. The company has also initiated a
proof-of-concept study to evaluate the ability of CORLUX to mitigate weight
gain associated with the use of olanzapine. For more information, please
visit corcept.
Forward-looking Statements
Statements made in this news release -- other than statements of
historical fact -- are forward-looking statements. These include
information relating to Corcept's PMD clinical development program, FDA
agreements, and the timing of the completion of pivotal Phase 3 trials.
Forward-looking statements are subject to a number of known and unknown
risks and uncertainties that might cause actual results to differ
materially from those expressed or implied here. For example, there can be
no assurances on the efficacy, safety, completion or success of clinical
trials; the regulatory process or regulatory approvals; or commercial
success; in addition, trial timetables may not be accurate. Risk factors
are explained in the company's SEC filings, all of which are available from
its Web site ( corcept ) or from the SEC's Web site ( sec ).
The company does not have any intention or duty to update forward-looking
statements made in this news release.
Corcept Therapeutics Incorporated
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