Corcept announces results from open-label portion of Phase 3 GRACE trial

Corcept Therapeutics announced positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective cortisol modulator relacorilant in patients with all etiologies of endogenous Cushing’s syndrome. GRACE has two parts. GRACE’s primary endpoint is maintenance of blood pressure control in the “randomized withdrawal” phase, with maintenance of glycemic control as the key secondary endpoint. Other key secondary and exploratory endpoints in the randomized withdrawal phase include changes in weight, waist circumference, cognitive impairment and Cushing’s Quality of Life score. Patients in the open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other key secondary and exploratory endpoints. The drug was well-tolerated, consistent with relacorilant’s known safety profile. Rapid and sustained improvements in systolic blood pressure and diastolic blood pressure were observed in all patients with hypertension, with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm Hg at 22 weeks. Clinically meaningful and statistically significant improvements in glucose metabolism were observed for all patients with hyperglycemia. Statistically significant improvements in other symptoms of Cushing’s syndrome, including body weight, waist circumference, cognition and Cushing’s Quality of Life score, were observed in all patients during the open-label phase of the study.