MENLO PARK, Calif., April 01, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), 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 cortisol, today announced the publication of an abstract in the April-May supplemental issue of the Journal of the Endocrine Society (JES). The abstract describes the Phase 3 trial (entitled “GRADIENT”) of relacorilant in patients with Cushing’s syndrome caused by adrenal adenomas or hyperplasia. Corcept’s poster describing the trial had been accepted for presentation at the 2020 Annual Meeting of the Endocrine Society (ENDO), which has been cancelled.
“We are excited to present the design of a Phase 3 trial of our selective cortisol modulator, relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “GRADIENT is the first randomized, double-blind, placebo-controlled trial in patients with this etiology of Cushing’s syndrome. These patients experience poor health outcomes despite having a more indolent course of disease.”
GRADIENT (NCT04308590) has a planned enrollment of 130 patients at sites in the United States and Europe. Participants will receive either relacorilant or placebo for six months, with the primary endpoints being improvement in glucose metabolism and hypertension. Many of the investigators for relacorilant’s ongoing Phase 3 GRACE trial (NCT03697109) will also participate in GRADIENT. Our poster presentation of GRADIENT’s Phase 3 design is available at the Research & Pipeline / Publications tab of our website.
|Journal of the Endocrine Society |
Volume 4, Issue Supplement 1
|GRADIENT: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Assess the|
Efficacy and Safety of a Selective Glucocorticoid Receptor Modulator, Relacorilant, in Patients With
Autonomous Cortisol Secretion Due to Cortisol-Secreting Adrenal Adenoma(s)/Hyperplasia
Richard J. Auchus, MD, PhD; Andreas Grauer, MD; Andreas G. Moraitis, MD
University of Michigan, Ann Arbor, MI, USA; Corcept Therapeutics, Menlo Park, CA, USA
Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, one of the two receptors to which cortisol binds. Relacorilant does not bind to the body's other hormone receptors, including the progesterone receptor. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing’s syndrome and advanced ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents through 2037. Relacorilant has received orphan designation in the United States and Europe for the treatment of both Cushing’s syndrome and pancreatic cancer.
About Corcept Therapeutics
Corcept is 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 stress hormone cortisol. The company’s medication Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing’s syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, exicorilant and miricorilant, that selectively modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators, including mifepristone, to treat a variety of serious disorders.