Corcept Therapeutics presented detailed 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. While the Phase 2 study did not meet its primary endpoint of improving the ALS Functional Rating Scale-Revised (ALSFRS-R) score, a significant survival benefit was observed.
An exploratory analysis at the one-year mark showed that patients randomized to 300 mg of dazucorilant lived significantly longer than those who received placebo, with a hazard ratio of 0.16 (p-value: 0.0009). At week 24 of the study, no deaths occurred in the 83 patients receiving 300 mg of dazucorilant, compared to five deaths in the 82-patient placebo group (p-value: 0.02).
Dazucorilant demonstrated an acceptable safety profile, with 92 percent of adverse events being mild to moderate in severity, and the frequency of severe and serious adverse events similar to placebo. Corcept is actively working with regulatory authorities to determine the optimal path forward for advancing dazucorilant, given the urgent need for life-extending treatments in ALS.
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