GRACE Phase 3 trial of relacorilant nears complete enrollment
Findings from trial are expected to support new drug application in 2024
Enrollment is nearly complete for a Phase 3 trial that is investigating the safety and effectiveness of relacorilant in people with Cushing’s syndrome due to any underlying cause, according to a corporate update from its developer, Corcept Therapeutics.
The trial, called GRACE (NCT03697109), is enrolling about 130 people with Cushing’s from any underlying cause who have type 2 diabetes, impaired glucose tolerance, and/or high blood pressure. Findings from the study are expected to support a new drug application (NDA) — to be filled by March 2024 — seeking the approval of relacorilant to treat Cushing’s syndrome due to any cause.
“We are pleased to announce that we believe that we have enough patients in screening in our GRACE trial to complete enrollment in the coming weeks,” Bill Guyer, Corcept’s chief development officer, said in a company press release. “We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first quarter of 2024.”
Relacorilant oral therapy designed to block the glucocorticoid receptor
Cushing’s syndrome is a condition characterized by excessive cortisol levels in the body. In many cases, this is caused by a tumor in the brain’s pituitary gland, which produces large amounts of the cortisol-controlling adrenocorticotropic hormone (ACTH). This specific form of the condition is known as Cushing’s disease.
In other cases, patients have tumors in the adrenal glands sitting atop the kidneys that directly increase cortisol production.
Relacorilant is an investigational oral therapy designed to block the glucocorticoid receptor, one of cortisol’s receptors. As a result, the therapy is expected to lessen the effects of excessive cortisol levels in the body.
Enrolment is also ongoing in a second, international Phase 3 trial, called GRADIENT (NCT04308590), which is testing relacorilant in people with Cushing’s syndrome caused by a tumor in the adrenal glands. The trial is underway at several sites in the U.S., EU, and Israel.
“The Phase 3 GRADIENT trial will produce valuable data about an etiology [cause] of Cushing’s syndrome that affects many patients but has not been subject to rigorous, controlled study,” Guyer said.
Corcept commercializes Korlym (mifepristone), a therapy approved for the management of high blood sugar, also known as hyperglycemia, in adults with Cushing’s syndrome who have type 2 diabetes or glucose intolerance, and for whom surgery was not an option or was ineffective.
Phase 4 trial to test Korlym in patients with high cortisol
The company also announced in its corporate update that it plans to launch a Phase 4 trial soon to assess the prevalence of excessive cortisol levels in patients with hard-to-treat type 2 diabetes, and treat those found to have elevated cortisol levels with Korlym.
The trial, called CATALYST, is expected to enroll around 1,000 participants. According to the company, enrollment should be completed by the end of the year.
“The most prominent diabetologists in the country helped design and are participating in this study. We expect CATALYST to produce data that will improve the screening and treatment of these patients,” Guyer said.