Corcept Reports Phase 3 GRACE Trial Success for Relacorilant in Cushing’s Syndrome

On May 28, 2024, Corcept Therapeutics Incorporated (NASDAQ: CORT), a company specializing in the development of medications for severe endocrinologic, oncologic, metabolic, and neurologic disorders, revealed promising results from its Phase 3 GRACE trial. This trial investigated relacorilant, a selective cortisol modulator, in patients with Cushing’s syndrome, a condition characterized by excessive cortisol levels.

The GRACE study, which is split into two phases, showed encouraging outcomes. Initially, on April 22, Corcept reported that patients in the open-label phase exhibited statistically significant improvements in hypertension and hyperglycemia, symptoms often associated with Cushing’s syndrome. Patients who showed pre-specified improvements in these conditions were eligible to enter the second, randomized, double-blind withdrawal phase. In this phase, participants were either continued on relacorilant or switched to a placebo for a duration of 12 weeks.

The trial successfully met its primary endpoint during the randomized withdrawal phase. Results demonstrated that patients on relacorilant maintained better blood pressure control compared to those on placebo, with an odds ratio of 0.17 and a p-value of 0.02. Relacorilant was well-tolerated in both study phases, showing no significant differences in safety profiles between the treatment and placebo groups.

Additional findings from the GRACE trial will be presented at the Endocrine Society (ENDO) annual meeting in Boston on June 3, and at the Heart in Diabetes (HiD) conference in Philadelphia on June 7. Corcept plans to submit their New Drug Application (NDA) for relacorilant in the third quarter.

Dr. Rosario Pivonello, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy, expressed optimism about the findings. “The GRACE data provide strong support for relacorilant's use in patients with endogenous hypercortisolism. The clinically significant improvements in hypertension, hyperglycemia, and other Cushing’s syndrome symptoms, without a significant safety burden, are highly encouraging for both physicians and patients,” he said.

Bill Guyer, PharmD, Corcept’s Chief Development Officer, highlighted the importance of these results. “The positive outcomes from GRACE are a significant milestone for patients and our upcoming NDA for relacorilant. Patients on relacorilant showed rapid and sustained improvements in hypertension and were 5.9 times more likely to maintain their hypertension response compared to the placebo group. We look forward to presenting more data from both the open-label and randomized withdrawal phases at medical conferences in June,” Guyer stated.

Relacorilant works by selectively binding to the glucocorticoid receptor, avoiding interaction with other hormone receptors in the body. Corcept is currently exploring relacorilant’s potential in treating various serious disorders, including ovarian, adrenal, and prostate cancer. The drug is protected by multiple patents and holds orphan drug designation in the U.S. and the EU for Cushing’s syndrome treatment.

For over two decades, Corcept has focused on the modulation of cortisol to develop treatments for various serious conditions. This effort has led to the discovery of over 1,000 proprietary selective cortisol modulators. The company is conducting advanced clinical trials for patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS), and liver disease. In 2012, Corcept launched Korlym®, the first FDA-approved medication for Cushing’s syndrome. Corcept is based in Menlo Park, California.

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