Corcept Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism

Corcept Therapeutics Incorporated recently 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.

“The data from GRACE make a compelling case for the use of relacorilant in patients with endogenous hypercortisolism. 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,” said Rosario Pivonello, MD, PhD, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy.

“GRACE’s clearly positive results are a welcome development for patients and constitute a significant step toward our new drug application for relacorilant,” added Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Patients receiving relacorilant exhibited rapid and sustained improvements in hypertension and were 5.9 times more likely to maintain their hypertension response compared to patients receiving placebo. We plan to present data from the open-label and randomized withdrawal phases of GRACE at medical conferences in June.”

Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to Cushing’s syndrome, including ovarian, adrenal and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in the US and the European Union for the treatment of Cushing’s syndrome.

For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the US FDA for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, CA. For more information, visit Corcept.com.