Piper: CORT :Special Protocol Assessments Signed For Corlux
2004-08-30 09:00 (New York)
Thomas Wei, Senior Research
Corcept Therapeutics (CORT - $7.44)
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* Corcept And FDA Sign Binding Agreement For Corlux Phase III Trials. Corcept signed two special protocol assessments (SPAs) with the FDA for two Phase III trials of its psychiatric drug, Corlux, for the treatment of psychotic major depression (PMD).
* Study 07 Design Generally As Expected But Study 06 Significantly Different. The design of one of the Phase III trials (Study 07) is generally in line with previous expectations. The 07 study will enroll approximately 280 patients at 20 sites in the U.S. Patients will be randomized to receive either 600 mg Corlux or placebo for
7 days. During this time, patients will not be allowed any background antidepressants or antipsychotics, but patients will be allowed to receive antidepressants after day
7. The second Phase III trial, however, is significantly different relative to our previous expectations. As opposed to a modified 07 study design, the 06 study will be a dose-ranging study that will enroll 440 patients at 30 sites to be randomized to receive placebo, 300 mg, 600 mg or 1200 mg Corlux for 7 days. Patients will be allowed background antidepressants from day 1. This dose ranging study builds upon the company's prior dose-ranging study, which tested doses of 50 mg, 600 mg and 1200 mg.
* Modified Primary Endpoint Also Different From Expectations. We had previously expected the primary endpoint of the Phase III trials would be the proportion of patients who achieve a 50% reduction in the Positive Symptom Subscale of the Brief Psychiatric Rating Scale (BPRS-PSS) at both day 7 and day 28. One key change in the SPAs is that the primary endpoint of the trial will need to be maintained through day 56. A post-hoc analysis of a subpopulation of patients enrolled in Corcept's prior Phase III study for whom 56 day data are available demonstrated a statistically significant difference relative to placebo on this endpoint. Specific details from this 56-day analysis will be presented at a major medical meeting or published in a peer-reviewed journal along with the full data from the study.
* Data Expected In 1H06. The 07 study will be initiated immediately, with the 06 study to be started in 4Q04.
The company believes that the increase in the number of centers in Study 06, as well as the 3:1 randomization, will facilitate a 1H06 data announcement, despite the greatly increased size of the study and the longer follow-up, relative to our previous expectations.
INVESTMENT RECOMMENDATION: We believe that the Phase III program for Corlux is high-risk, high-reward and that we will likely need to wait for positive Phase III data prior to significant share appreciation.
RISKS TO ACHIEVEMENT OF TARGET PRICE: Risks include but are not limited to: (1) significant changes to the trial design following the SPA process with the FDA; (2) slower-than-expected rates of enrollment in the new Phase III trials of Corlux; (3) negative data from either Phase III trial of Corlux; and (4) financing risk prior to profitability.
COMPANY DESCRIPTION: Corcept is developing Corlux for psychotic major depression and other psychiatric disorders. |
