Corcept Therapeutics unveiled significant findings from its Phase 2 DAZALS study, indicating that dazucorilant enhances overall survival in individuals battling Amyotrophic Lateral Sclerosis (ALS).
Study Outcomes
The DAZALS trial encompassed 249 ALS patients randomized to receive either 150 mg, 300 mg of dazucorilant, or a placebo daily over 24 weeks. While the primary goal of improving the ALS Functional Rating Scale-Revised (ALSFRS-R) was not achieved, the study successfully met its secondary objective by demonstrating increased overall survival at the 24-week mark in the 300 mg dazucorilant group, with no deaths reported compared to five in the placebo cohort.
Long-Term Benefits and Regulatory Path
Further analysis at the one-year milestone revealed that patients on the 300 mg dosage continued to experience significant survival advantages over those on placebo. Encouraged by these results, Corcept is actively consulting with regulatory bodies in the United States and Europe to determine the best course of action for advancing dazucorilant’s approval as an ALS treatment.
– **Dazucorilant significantly improves one-year survival rates in ALS patients.**
– **Primary endpoint related to ALSFRS-R scores was not met, indicating the need for alternative efficacy measures.**
– **Safety profile remains favorable, with most adverse events being mild to moderate.**
Dazucorilant’s ability to extend the lives of ALS patients underscores the potential of cortisol modulation in managing neurodegenerative disorders. These findings not only provide a new avenue for treatment but also emphasize the importance of exploring secondary endpoints in clinical trials to fully understand a drug’s impact. As Corcept engages with regulators, the continued positive outcomes from the extension study will be pivotal in securing approval and ultimately offering a much-needed therapeutic option for those affected by ALS.
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