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Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced preliminary results from the prevalence phase of its ongoing CATALYST study of Cushing's syndrome (hypercortisolism) in patients with difficult-to-control type 2 diabetes. With a planned enrollment of 1,000 patients, CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in this patient population.
Of the first 700 patients enrolled in CATALYST, 24 percent were identified as having hypercortisolism – a prevalence rate that has been consistent throughout the study. Final results from the prevalence phase will be presented at the American Diabetes Association's 84th Scientific Sessions in June.
"These results are very powerful. While cortisol's role in diabetes is well understood, most diabetes care providers have not considered hypercortisolism as a source of the disease for their patients with difficult-to-control diabetes. These preliminary results clearly indicate that hypercortisolism should be considered – as the prevalence rate is significantly higher than previously assumed," said Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. "We look forward to seeing the full results of this study, as they will guide physicians to better identify patients with hypercortisolism and make informed treatment decisions to prevent the serious and deadly complications associated with the disease."
"We look forward to advancing this landmark study to completion," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "We deeply appreciate the investigators and patients participating in CATALYST. Almost all of the patients identified as suffering from hypercortisolism currently go undiagnosed. We expect that CATALYST's findings will lead to more accurate diagnoses – and ultimately treatment – for this vulnerable population."
About the Phase 4 CATALYST Study
CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assesses the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, which the study defines as hemoglobin A1c greater than 7.5 percent despite receiving optimal therapies. Patients from this group with a dexamethasone suppression test value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL are identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients are eligible to enter CATALYST's treatment phase, in which they are randomized, 2:1, to receive treatment with either Korlym® or placebo. CATALYST is being conducted at 35 sites in the United States.
Posted In: CORT
