Mixed Phase II results for Corcept’s dazucorilant

US commercial-stage drugmaker Corcept Therapeutics (Nasdaq: CORT) has presented results from its DAZALS study of dazucorilant in patients with amyotrophic lateral sclerosis (ALS) at the European Network to Cure ALS (ENCALS) 2025 annual meeting.

DAZALS is a randomized, double-blind, placebo-controlled Phase II study in which 249 patients with ALS were randomized to receive either 150mg of dazucorilant, 300mg of dazucorilant or placebo, daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in a long-term extension study in which all patients received 300mg of dazucorilant. The primary endpoint in DAZALS was the difference in ALSFRS-R between patients who received dazucorilant and those who received placebo. Overall survival was a secondary endpoint.

Although DAZALS did not meet its primary endpoint, patient survival significantly improved. At week 24 of the study, no deaths had occurred in the 83 patients who received 300 mg of dazucorilant, while there were five deaths in the 82-patient placebo group (p-value of 0.02).