Corcept Presents Data from Treatment Phase of CATALYST Trial at American Diabetes Association’s 85th Scientific Sessions with Simultaneous Publication in Diabetes Care

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 presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym in patients with hypercortisolism (Cushing’s syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association’s 85^th Scientific Sessions.

CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c (HbA1c), which decreased 1.47 percent from baseline, compared to a 0.15 percent decrease in patients who received placebo (p-value: < 0.001). Of the 91 patients in the treatment group, 65 (71%) received at least 600mg of Korlym and 28 (31%) received 900mg. Patients who received 900mg of Korlym had an improvement in HbA1c of 2.01 percent, compared to a 0.16 percent decrease in patients who received placebo (p-value: < 0.001). The trial also met its secondary endpoints, as patients who received Korlym exhibited significantly reduced body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002), compared to patients who received placebo. Patients receiving Korlym achieved these improvements despite reducing or discontinuing their glucose-lowering medications. Adverse events in CATALYST were manageable and consistent with Korlym’s known safety profile. The most common adverse events (> 20% of participants receiving Korlym) were hypokalemia, fatigue and nausea.

The conference presentations can be found here. Results were published simultaneously in Diabetes Care, in an article titled “Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment.”

CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial’s treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase.