Corcept says DAZALS study did not meet primary endpoint

Corcept Therapeutics (CORT) Incorporated announced results from the DAZALS study, a randomized, double-blind, placebo-controlled, Phase 2 trial evaluating two doses of its proprietary selective cortisol modulator dazucorilant in patients with ALS. Upon completion of the trial, patients were eligible to enter an open-label, long-term extension study, in which they received 300 mg of dazucorilant. DAZALS did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised in patients who received dazucorilant compared to those who received placebo. Patients who received dazucorilant experienced substantially more gastrointestinal upset at the onset of treatment than those who received placebo. During the 24-week study, no deaths were observed in the 300 mg arm, compared to 5 deaths in the placebo group. The open-label, long-term extension study will continue and overall survival will be assessed in March 2025 after all patients have had one year pass since the onset of treatment. Dazucorilant has been granted Fast Track Designation by the U.S. Food and Drug Administration. Complete results from the DAZALS study will be presented at a medical conference next year.