Tuesday, Corcept Therapeutics Incorporated CORT announced that the GRACE Phase 3 trial of relacorilant in patients with hypercortisolism (Cushing’s syndrome) met its primary endpoint.
In April, Corcept announced that patients in GRACE’s initial, open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, and other symptoms experienced by patients with Cushing’s syndrome.
Patients who exhibited pre-specified improvements in hypertension, hyperglycemia or both were allowed to enter the trial’s randomized, double-blind withdrawal phase. For 12 weeks, half of the patients continued to receive relacorilant, and half received a placebo.
GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant compared to placebo (odds ratio: 0.17; p-value: 0.02).
Consistent with its known safety profile, relacorilant was well-tolerated in both phases of GRACE, with no differences in the randomized withdrawal phase between the relacorilant and placebo groups.
The company expects to submit its New Drug Application in the third quarter.
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Price Action: CORT shares are up 11.4% at $30.65 at last check Tuesday.
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