The trial, named Study 07, was a randomized, double-blind, placebo-controlled study. The primary endpoint was the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both day seven and day 56.
The study results revealed that 30.5% of the patients receiving Corlux and 28.6% of the patients receiving placebo were responders. The two key secondary endpoints of the study were similarly negative.
Investors reacted badly to the news, causing the company’s stock to plummet by over 70% in premarket trading. However, Corcept maintained that, while disappointed by these trial results, it still has faith in two other phase III trials that are currently underway.
These trials will be crucial as Corlux is Corcept’s lead product candidate. In addition to the phase III trials in psychotic major depression, 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.