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.
Read Next: What’s Going On With Stress Hormone Modulator-Focused Corcept Therapeutics’ Stock Friday?
Price Action: CORT shares are up 11.4% at $30.65 at last check Tuesday.
Photo via Shutterstock
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.