Contact Information: CONTACT: Fred Kurland Chief Financial Officer Corcept Therapeutics 650-327-3270 Email Contact www.corcept.com
Corcept Therapeutics Announces Phase 3 Study Evaluating CORLUX(R) for Psychotic Major Depression Misses Primary Endpoint
Statistically Significant Correlation Between Plasma Levels and Clinical Outcome Achieved During Treatment
Management Will Host a Conference Call and Live Webcast on March 20, 2007 at 9:00 a.m. EDT
| Source: Corcept Therapeutics
MENLO PARK, CA -- (MARKET WIRE) -- March 19, 2007 --Corcept Therapeutics Incorporated (NASDAQ : CORT ) today announced that Study 06, the last of three Phase 3 trials
evaluating CORLUX for treating the psychotic features of Psychotic Major
Depression (PMD), did not achieve statistical significance with respect to
its primary endpoint. However, there was a statistically significant
correlation between plasma levels and clinical outcome achieved during
treatment. Further, the company reported that the incidence of serious
adverse events did not differ between placebo and any of the three CORLUX
dose groups.
Patients whose plasma levels rose above a predetermined threshold
statistically separated from both those whose plasma levels were below the
threshold and those patients who received placebo. This confirmed a similar
finding in Study 07, another Phase 3 trial testing CORLUX for PMD completed
in 2006.
"While we are disappointed that the trial did not meet the primary
endpoint, we are particularly encouraged to have met the important
predefined threshold concentration endpoint with statistical significance,"
said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. "This
study confirms our previous observation that at higher plasma levels the
drug candidate is able to demonstrate desired clinical effects. In
particular, those patients in Study 06 who achieved a predetermined level
of 1661 nanograms of CORLUX per milliliter of plasma separated from the
placebo group with statistical significance."
Commenting on these results, Ned H. Kalin, M.D., Hedberg Professor and
Chair of the Department of Psychiatry at the University of Wisconsin, said,
"The correlation between plasma levels of drug and response rates found in
this trial is very exciting. The results of this study show that when
psychotically depressed patients achieve a threshold concentration of
CORLUX in their system, a rapid and sustained clinical response is likely.
This is a strong demonstration of a drug effect in an illness that is
potentially devastating and difficult to treat." Dr. Kalin is a member of
Corcept's Scientific Advisory Board.
Next Phase 3 Clinical Trial Being Planned
Robert L. Roe, M.D., Corcept's President, said, "We believe that the
confirmation of a drug concentration threshold for efficacy as well as
other observations from Study 06 and the company's two recently completed
Phase 3 clinical trials will serve as a strong basis for the company's next
Phase 3 study. In the upcoming trial, which is planned to commence later in
2007, we expect to use a dose level of 1200 mg once per day for seven days
because, in Study 06, 80% of the patients achieved a drug plasma level
sufficient for a strong clinical response at that dose. In our initial
review of a summary of the safety data, we have seen no difference between
any of the dose levels used in Study 06. We believe that this change in
dose as well as other modifications to the protocol should allow us to
definitively demonstrate the efficacy of CORLUX in the treatment of the
psychotic features of PMD."
About Study 06
Study 06 was a randomized, double-blind, placebo-controlled study in which
443 patients were enrolled at 45 sites in the United States and Europe. The
primary endpoint, a responder analysis, was 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 56.
Specifically, the BPRS is an 18-item rating instrument used to assess
psychopathology, and the PSS is a subset of four items in the BPRS that
specifically measure psychosis. Patients were evenly distributed among
three active dose groups (300 mg, 600 mg and 1200 mg) or a placebo group,
with patients receiving once daily dosing for a period of seven days. All
patients in the study were off any antidepressant and antipsychotic
medication for at least one week before the seven day treatment period and
received concomitant antidepressant therapy starting on Day 1 through Day
56. As was the case with the company's two previously completed Phase 3
studies evaluating CORLUX for PMD, treatment with antipsychotic medications
or electroconvulsive therapy was not allowed at any time during this study.
In Corcept's previous Phase 3 studies, as in Study 06, the response rate in
patients who received CORLUX exceeded the response rate in patients who
received placebo but not with statistical significance.
Conference Call and Live Webcast on March 20, 2007
Management will host a conference call on March 20, 2007 at 9:00 a.m. EDT
to provide an update on its PMD clinical program. To participate, please
dial 866-297-6394 for domestic calls or 847-944-7315 for international
calls. A telephone replay will also be available by dialing 877-213-9653
for domestic calls or 630-652-3041 for international calls. The access
code is 17309243#. The replay will be available until 4:00 p.m. EDT on
April 3, 2007.
A live webcast of the conference call can be accessed at www.corcept.com.
The event will be archived and available for replay until 4:00 p.m. EDT on
April 3, 2007.
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.
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 www.corcept.com.
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 and the timing of the
completion of 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, enrollment
completion or success of clinical trials; the regulatory process or
regulatory approvals; 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 (www.corcept.com) or from the
SEC's Web site (www.sec.gov). The company does not have any intention or
duty to update forward-looking statements made in this news release.