Relacorilant Meets Primary Endpoint in Phase 3 GRACE Trial for Hypercortisolism

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Relacorilant achieves primary endpoint in phase 3 GRACE trial among patients with hypercortisolism and hyperglycemia, hypertension or both, with sNDA expected in Q3 2024.

Rosario Pivonello, MD, PhD |  Credit: University of Naples Federico II

Rosario Pivonello, MD, PhD
Credit: University of Naples Federico II

Relacorilant has met the primary endpoint in the second part of its phase 3 trial, with results suggesting use of the selective cortisol modulator improved loss of blood pressure control among patients with hypercortisolism in the randomized withdrawal phase of the trial.

Announced by Corcept Therapeutics on May 28, 2024, the results of the withdrawal phase of the trial come less than a month after Corcept announced patients in the open-label phase found patients with Cushing’s syndrome and hyperglycemia, hypertension, or both experienced clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other key secondary and exploratory endpoints. Based on the data, Corcept Therapeutics expects to submit its application for approval to the US Food and Drug Administration in Q3 2024.

“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 principal investigator Rosario Pivonello, MD, PhD, professor of Endocrinology at Università Federico II di Napoli, Italy.1

A 2-part, phase 3 trial, the first part of the GRACE trial was an open-label phase where 152 patients with Cushing’s syndrome and either hypertension, hyperglycemia, or both received relacorilant for 22 weeks.1,2

In this portion of the trial, 63% of patients with hypertension met the study’s response criteria, with use associated with rapid and sustained improvements for both systolic (mean reduction, 7.9 mmHg; P <.0001) and diastolic (mean reduction, 5.4 mmHg; P <.0001) at 22 weeks. Among those with hyperglycemia, all patients achieved clinically meaningful and statistically significant improvements in glucose metabolism, with 50% meeting the study’s response criteria.2

The primary outcome of interest for the GRACE trial, as a whole, was the maintenance of blood pressure control within part of the trial, which was the double-blind, randomized withdrawal phase. In this portion of the trial, patients who met response criteria were randomized 1:1 to continue relacorilant or switch to placebo therapy for 12 weeks.1,2

According to the May 28 announcement from Corcept Therapeutics, the trial met its primary endpoint, with results indicating loss of blood pressure control was 83% less likely to occur among patients relieving relacorilant compared to placebo (OR, 0.17; P = .02). In the release, Corcept Therapeutics also noted results of safety analyses from both phases indicated relacorilant was well-tolerated and no new safety signals arose during the randomized withdrawal portion of the trial.1

“GRACE’s clearly positive results are a welcome development for patients and constitute a significant step toward our new drug application for relacorilant,” said Bill Guyer, PharmD, chief development officer at Corcept Therapeutics.1 “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.”

References:

  1. Corcept Therapeutics. Corcept announces primary endpoint met in pivotal Phase 3 GRACE trial of relacorilant in patients with Cushing's syndrome [news release]. Corcept Therapeutics website. https://ir.corcept.com/news-releases/news-release-details/corcept-announces-primary-endpoint-met-pivotal-phase-3-grace. Published May 28, 2024. Accessed May 28, 2024.
  2. Corcept Therapeutics. Corcept announces positive results from the open-label portion of the pivotal Phase 3 GRACE trial of relacorilant in patients with Cushing's syndrome [news release]. Corcept Therapeutics website. https://ir.corcept.com/news-releases/news-release-details/corcept-announces-positive-results-open-label-portion-pivotal. Published April 22, 2024. Accessed May 28, 2024.
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