Corcept Announces Positive Results From Open-Label Portion of Pivotal Phase 3 GRACE Trial in Patients With Cushing’s Syndrome GRACE has two parts. In the “open-label” phase, 152 patients with Cushing’s syndrome and either hypertension, hyperglycemia or both received relacorilant for 22 weeks. Patients who exhibited pre-specified improvements in either or both symptoms were given the opportunity to enter the trial’s randomized, double-blind withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo for 12 weeks. GRACE’s primary endpoint is maintenance of blood pressure control in the “randomized withdrawal” phase, with maintenance of glycemic control as the key secondary endpoint. Other key secondary and exploratory endpoints in the randomized withdrawal phase include changes in weight, waist circumference, cognitive impairment and Cushing’s Quality of Life score. The data provided below are from GRACE’s open-label phase. “These open-label results are compelling, and they provide important information about the treatment of hypercortisolism,” said Richard Auchus, MD, PhD, Professor of Internal Medicine, Division of Metabolism, Endocrinology & Diabetes at the University of Michigan and Chief of the Endocrinology & Metabolism Section at the Ann Arbor VA Medical Center. “Patients showed marked improvement across a broad range of signs and symptoms, without significant safety burden. Due to relacorilant’s unique mechanism of action, we are not observing other toxicities seen with current therapies, which positions relacorilant to potentially become a new standard of care for patients with this disease.” “These data improve on the results we observed in our Phase 2 study,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Cushing’s syndrome has many signs and symptoms, which is why it is so important that patients in GRACE’s open-label phase exhibited improvements across a broad range of clinically meaningful endpoints. We expect to build on these results in the trial’s randomized withdrawal phase. We plan to present data from the open-label and randomized withdrawal phases at a medical conference in June and remain on track to submit our NDA this quarter.” Rapid and sustained improvements in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were observed in all patients with hypertension, with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm Hg at 22 weeks (p-values: See Figures 1 and 2. Glucose metabolism was measured by several diagnostic tests, including the oral glucose tolerance test (glucose area under the curve or AUCglucose), hemoglobin A1C (HbA1c) and fasting glucose.
Clinically meaningful and statistically significant improvements in glucose metabolism were observed for all patients with hyperglycemia, which includes patients with diabetes and impaired glucose tolerance (pre-diabetes). Data showed improvements in mean AUCglucose of 3.3 h*mmol/L, mean HbA1c of 0.3 percent and mean fasting glucose of 12.4 mg/dL at 22 weeks (p-values: See Figures 3 and 4. Statistically significant improvements in other symptoms of Cushing’s syndrome, including body weight, waist circumference, cognition (as assessed by the Trail Making Test) and Cushing’s Quality of Life score, were observed in all patients during the open-label phase of the study (all p-values: Safety Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include those concerning: relacorilant, including its clinical attributes and potential to become a treatment for patients with Cushing’s syndrome or any other disorder, the conduct, pace and outcome of GRACE, including its randomized withdrawal phase, regulatory oversight of relacorilant, timing of relacorilant’s NDA submission and its prospects for approval by the FDA and other authorities, relacorilant’s acceptance and use by physicians and patients and its commercial prospects, and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. communications@corcept.com
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