GlobeNewswire Inc | Jul 28, 2020 08:30AM EDT

July 28, 2020

MENLO PARK, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- 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 cortisol, today announced enrollment of its first patient in GRADIENT, a double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients with Cushings syndrome caused by adrenal adenomas or hyperplasia.

We are excited to begin enrollment in GRADIENT, said Andreas Grauer, MD, Corcepts Chief Medical Officer. Patients with Cushings syndrome of adrenal origin have poor health outcomes, even if the course of their decline is sometimes less rapid than in Cushings syndrome of other etiologies. GRADIENT is the first systematic study of the benefits of a medical treatment in these patients. We expect it to contribute meaningfully to physicians ability to provide optimal care.

GRADIENT is a double-blind, placebo-controlled Phase 3 trial, with a planned enrollment of 130 patients at sites in the United States and Europe. Half of the patients will receive relacorilant and the other half placebo for six months. The trials primary endpoints are improvement in glucose metabolism and hypertension.1

GRADIENT is Corcepts second Phase 3 trial of relacorilant in patients with hypercortisolism. The companys pivotal GRACE trial is enrolling 130 patients with all etiologies of Cushings syndrome at sites in the United States, Canada, Europe and Israel. Corcept expects the results of GRACE, if positive, to be the basis for relacorilants new drug application as a treatment for all etiologies of Cushings syndrome.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushings syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushings 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. Korlym was the first drug approved by the U.S. Food and Drug Administration for patients with Cushings syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.

1 See our poster at the Research & Pipeline / Publications tab of our website and Clinicaltrials.gov (NCT04308590).

CONTACT:Christopher S. James, MDDirector, Investor RelationsCorcept Therapeutics650-684-8725cjames@corcept.comwww.corcept.com