Corcept Primary Endpoint Met in Pivotal Phase 3 Cushing's Trial

 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing’s syndrome), met its primary endpoint.

The GRACE study has two parts. On April 22, 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 given the opportunity to enter the trial’s randomized, double-blind withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo, for 12 weeks. 

GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as 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. Additional data will be presented at the Endocrine Society (ENDO) annual meeting in Boston (poster presentation, June 3) and the Heart in Diabetes (HiD) conference in Philadelphia (oral presentation, June 7). The company expects to submit its New Drug Application in the third quarter.

https://www.globenewswire.com/news-release/2024/05/28/2888977/0/en/Corcept-Announces-Primary-Endpoint-Met-in-Pivotal-Phase-3-GRACE-Trial-of-Relacorilant-in-Patients-With-Hypercortisolism-Cushing-s-Syndrome.html