The last of three phase III trials evaluating Corlux for treating the psychotic features of psychotic major depression (PMD), did not achieve statistical significance compared to placebo. However, 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.
“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 Belanoff, Corcept’s CEO. “This study confirms our previous observation that at higher plasma levels the drug candidate is able to demonstrate desired clinical effects.”
The company is now planning another phase III study for later in 2007, in which it will use a dose level of 1200 mg once per day for seven days. Corcept said that it believes that the change in dose as well as other modifications to the protocol should allow the company to definitively demonstrate the efficacy of Corlux in the treatment of the psychotic features of PMD.