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| CORT > SEC Filings for CORT > Form 8-K on 2-Feb-2009 | All Recent SEC Filings |
2-Feb-2009
Regulation FD Disclosure
On February 2, 2009, Corcept Therapeutic Incorporated (the "Company") issued a
press release announcing positive results from a clinical study that tested
whether CORLUX mitigates the weight gain associated with Risperdal, which is
attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including
the exhibits attached hereto, is being "furnished" pursuant to Item 7.01 and
shall not be deemed "filed" for any purpose, including for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise subject to the liabilities of that Section. The information
in this Item 7.01 of this Current Report on Form 8-K, including the exhibits
attached hereto, shall not be deemed incorporated by reference into any filing
under the Securities Act of 1933, as amended or the Exchange Act regardless of
any general incorporation language in such filing.
Item 8.01. Other Events
On February 2, 2009, the Company announced positive results from a clinical
study that tested whether CORLUX mitigates the weight gain associated with
Risperdal. The data demonstrated that adding CORLUX to Risperdal treatment in
healthy subjects resulted in a statistically significant reduction in weight
gain compared to that seen in subjects receiving Risperdal alone. Risperdal, a
leading antipsychotic for the treatment of schizophrenia and bipolar disorder,
is marketed by Johnson & Johnson. CORLUX is Corcept's late-stage GRII receptor
antagonist, which the company is also evaluating in ongoing Phase 3 trials for
psychotic depression and Cushing's Syndrome.
The data announced on February 2, 2009 confirmed results previously reported
from similar clinical studies of CORLUX which demonstrated statistically
significant mitigation of Zyprexa associated weight gain.
-- Study Design: The study was a four-week randomized double-blind controlled
study in 75 lean, healthy men (body mass index of 23 or less). Subjects were
randomized to receive either Risperdal plus placebo (n=30), Risperdal plus
CORLUX (n=30) or CORLUX plus placebo (n=15). Daily weights were recorded and a
range of metabolic parameters were measured.
-- Results: Subjects in the Risperdal alone group gained an average of 9.2
pounds, compared to a gain of 5.1 pounds in the Risperdal plus CORLUX group.
This difference was highly statistically significant (p < 0.0001). Additional
metabolic parameters, including fasting insulin, triglycerides and abdominal
fat, are being analyzed. Consistent with prior studies, CORLUX appeared to be
well tolerated.
Item 9.01. Financial Statements and Exhibits
(a) Financial statements:
None
(b) Pro forma financial information:
None
(c) Shell company transactions:
None
(d) Exhibits. The following material is furnished as an exhibit to this Current
Report on Form 8-K:
99.1 Press Release of Corcept Therapeutics Incorporated dated February 2, 2009
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