Press Release: Corcept Therapeutics Announces Phase 3 Study Evaluating CORLUX | FierceBiotech
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`El
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`Release: Corcept Therapeutics Announces Phase 3 Study Evaluating CORLUX
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`Mar 20, 2007 1:32pm
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`3aa
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`Corcept Therapeutics Announces Phase 3 Study Evaluating CORLUX(R) for
`Psychotic Major Depression Misses Primary Endpoint 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 ofthe 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,
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`https://www flercebiotech com/bictech/press-release~corcept—therapeuticseannounces-phnse-3-study-cva1uating-corlux[7/‘29/2019 11:51:23 AM]
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`Press Release: Cogcept Therapeutics Announces Phase 3 Study Evaluating CORLUX l FierceBiotech
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`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 P88 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 am. 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. Atelephone 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
`pm. EDT on April 3, 2007. A live webcaSt ofthe conference call can be
`accessed at www.corcept.com. The event will be archived and available for
`replay until 4:00 pm. 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-ll
`antagonist, appears to reduce the effects ofthe 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 ofthe completion of Phase 3 trials
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`https //www fiercebiotech com/biolech/press-release-corcept—therapeutics—announces-phase-E-study-evaluating-corlux[7/29/20l9 11:51:23 AM]
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`Press Release: Corcept Therapeutics Announces Phase 3 Study Evaluating CORLUX | FierceBiotech
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`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.
`
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`Press Release: Corcepl Therapeutics Announces Phase 3 Study Evaluatmg CORLUX | F1crccBiotech
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