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Press Release CONTACT: CORCEPT
THERAPEUTICS ANNOUNCES PUBLICATION OF PHASE 2 CLINICAL STUDY RESULTS IN
THE JOURNAL OF BIOLOGICAL PSYCHIATRY MENLO PARK (August 7, 2006) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that an article describing the results of its Study 03, a Phase 2 clinical trial that serves as the primary basis for the design of the company's three Phase 3 trials, is available to the public at the web site of the Journal of Biological Psychiatry, at http://www.sobp.org/. The results of this study demonstrated with statistical significance that more patients treated with CORLUX® achieved a rapid and sustained reduction of the psychotic features of psychotic major depression (PMD) than did patients treated with placebo. Study 03 was a multi-center, randomized, placebo controlled study that evaluated 600 mg of CORLUX administered once daily over a period of seven days in patients with PMD. Patients were not allowed to receive any antipsychotic or antidepressant medication for at least seven days prior to or during administration of the study drug. The study randomized 221 patients on a one-to-one basis to receive either CORLUX or placebo. The results of this study showed that patients who received CORLUX were more likely than patients who received placebo to achieve a rapid and sustained reduction in psychosis as measured by a 30% reduction in the BPRS (Brief Psychiatric Rating Scale) at day 7 sustained to day 28. This difference was statistically significant (p value = .041). The BPRS is an 18-item rating instrument used to assess psychopathology. Additionally, 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 positive symptom subscale (PSS) at day 7 sustained to day 28. The PSS is a validated instrument containing the four items in the BPRS that more specifically measure psychosis. The subgroup of patients who exhibited at least mild psychotic symptoms on Day 0 (score = 12 on the BPRS PSS), and who received CORLUX separated with even greater statistical significance from those who received placebo. At the request of the FDA, the last third of patients enrolled in this trial were followed to Day 56. Of those patients who exhibited at least mild psychotic symptoms on Day 0 (score = 12 on the BPRS PSS), 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 (p value = 0.038). The results of Study
03 also indicated that CORLUX was well tolerated. There were no statistically
significant differences in adverse events observed between the CORLUX
group and the placebo group. About Psychotic
Major Depression (PMD) About Corcept Therapeutics
Incorporated
This press release
contains forward-looking statements that are based on management's current
expectations. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking statement
we make. There are significant risks and uncertainties in our pharmaceutical
research and development, including risks relating to the commencement
and success of our pivotal clinical trials, risks relating to the receipt
of necessary clinical and manufacturing regulatory approvals, and risks
relating to successful product commercialization. These and other risks
are described in greater detail in the "Risk Factors" section
of the final prospectus relating to our initial public offering, filed
with the SEC. We do not assume any obligation to update any forward-looking
statements. |