Last month Corcept Therapuetics Incoporated announced that the U.S. Food and Drug Administration (FDA) filed its New Drug Application (NDA) submission for the company’s proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing’s syndrome).
Corcept’s NDA is based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT trial, long-term extension trial, and a Phase 2 trial in hypercortisolism. Patients in these trials who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms. Relacorilant was well tolerated. Notably, there were no instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation – serious adverse events that can arise in patients taking currently approved medications – and no adverse events associated with activity at the progesterone receptor, such as endometrial thickening or vaginal bleeding.
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 was presented at the ENDO 2024 in Boston and the Heart in Diabetes (HiD) conference in Philadelphia.
“The data from GRACE make a compelling case for the use of relacorilant in patients with endogenous hypercortisolism,” says Rosario Pivonello, MD, PhD, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy. “That patients experienced clinically significant improvements in hypertension, hyperglycemia and the other signs and symptoms of Cushing’s syndrome, without significant safety burden, is greatly encouraging for physicians and the patients they seek to help.”
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