Corcept Therapeutics Launches Website Supporting Phase 3 Trial of Relacorilant in Patients With Cushing’s Syndrome
MENLO PARK, Calif. (March 23, 2019) – Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol, today announced a new website to support recruitment in the Phase 3 trial (known as “GRACE”) of Corcept’s proprietary compound, relacorilant, to treat patients with Cushing’s syndrome. The website, CushingResearch.com, matches interested patients to nearby study sites.
Corcept plans to enroll 130 patients in GRACE at 60 sites in the United States, Canada, Europe and Israel. Patients must have Cushing’s syndrome with symptoms including either (i) type 2 diabetes or impaired glucose tolerance and/or (ii) high blood pressure. These symptoms are common in patients with Cushing’s syndrome.
Patients who enroll in GRACE will be treated with relacorilant for 22 weeks, at which time patients who have achieved clinically meaningful improvements in glucose tolerance or hypertension will enter a randomized withdrawal phase lasting up to 12 weeks. Half of the patients entering the randomized withdrawal phase will continue receiving relacorilant. The rest will receive placebo. The rate and degree of relapse in patients receiving placebo will be measured against the same parameters in patients continuing relacorilant.
Relacorilant is a selective cortisol modulator that, unlike Corcept’s FDA-approved cortisol modulator, Korlym®, does not bind to the progesterone receptor (PR) and so does not cause PR-related side effects, such as vaginal bleeding, uterine thickening and termination of pregnancy. In its Phase 2 trial, relacorilant also did not cause hypokalemia (low potassium) – a common and frequently serious adverse event in patients taking Korlym.
Data from relacorilant’s Phase 2 trial were positive. Fifty percent of patients who received the range of relacorilant doses being administered in GRACE (known as the “high-dose cohort”) achieved improved glucose control. Sixty-four percent of patients in the high-dose cohort with hypertension exhibited reduced blood pressure. Patients in this cohort also met a wide range of secondary endpoints, including significant improvements in hypercoagulopathy, liver function, insulin resistance, cognition and mood. Relacorilant was generally well-tolerated in Phase 2 and there were no PR-related adverse events or instances of drug-induced hypokalemia.
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively. About Corcept Therapeutics Incorporated Corcept is a commercial-stage company engaged in the discovery and development of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Corcept’s approved product, Korlym, was the first FDA-approved treatment for patients with Cushing’s syndrome. Korlym modulates the activity of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds. The company has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and in the use of cortisol modulators, including Korlym, to treat a wide variety of serious disorders.