Corcept Therapeutics Therapy Fails Primary Goal But Extends Patient Survival In Amyotrophic Lateral Sclerosis Study

Corcept Therapeutics Incorporated CORT said on Thursday that it presented results from its Phase 2 DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting.

In December 2024, the company announced DAZALS did not meet its primary endpoint, which was the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received a placebo.

Patients who received dazucorilant experienced substantially more gastrointestinal upset at the onset of treatment than those who received a placebo.

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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 a placebo. Overall survival was a secondary endpoint.

Although DAZALS did not meet its primary endpoint, detailed results at the presentation showed 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.

An exploratory analysis at the one-year mark shows the survival benefit has continued.

Patients randomized to 300 mg of dazucorilant lived significantly longer than patients who received placebo and did not switch to 300 mg of dazucorilant in the extension study.

The difference between groups was pronounced, with a hazard ratio of 0.16 (p-value: 0.0009).

A similar survival benefit was observed in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study. The extension study is ongoing.

Dazucorilant has demonstrated an acceptable safety profile, with 92% of adverse events being mild to moderate in severity.

The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received a placebo. The most common adverse effect was mild to moderate, dose-related, transient abdominal pain.

On Monday, Corcept Therapeutics shared data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 American Society of Clinical Oncology Annual Meeting.

ROSELLA met its primary endpoint of improved progression-free survival.

Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30% reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherapy.

Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone.

Relacorilant plus nab-paclitaxel was well-tolerated, with a comparable safety profile between treatment arms.

Price Action: At the last check on Thursday, CORT stock was down 0.76% to $69.45.

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