Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with Amyotrophic Lateral Sclerosis (ALS) at ENCALS 2025 Annual Meeting

• DAZALS did not meet its primary endpoint of improved outcome in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to patients who received placebo
• DAZALS met its secondary endpoint of improved overall survival at week 24 of the study in patients who received 300 mg of dazucorilant compared to patients who received placebo
• Exploratory analysis at the one-year mark shows continued significant improvement in overall survival between patients who received 300 mg of dazucorilant and those who received placebo only
• Corcept seeking guidance from United States and European regulators on optimum path forward

Excerpt from the Press Release:

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting. The presentation can be found here.

DAZALS is a randomized, double-blind, placebo-controlled Phase 2 study in which 249 patients with ALS were randomized to receive either 150 mg of dazucorilant, 300 mg 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 300 mg 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).

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