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news.Corcept Therapeutics has reported the failure of the second of its three phase III trials evaluating Corlux for treating psychotic major depression.
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In August, Corcept said that the first of its trials for Corlux had failed. Corlux is Corcept’s lead product in development.
The primary endpoint of the study was the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale. The study revealed no meaningful separation in response between patients receiving Corlux and patients receiving placebo. The two key secondary endpoints of the study were similarly negative.
“It is interesting to note that there was a statistically significant separation between the Corlux and placebo groups on an endpoint commonly used to measure the efficacy of antipsychotic and antidepressant medications, change from baseline to study end,” said Joseph Belanoff, Corcept’s CEO. “However, because of the already high degree of response in the placebo group, it is difficult to determine how much additional clinical utility is conferred by this finding.”
Corcept will continue to enroll patients in another phase III study and has said it will announce the results of this trial early next year.