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Corcept Announces Positive Results From Open-Label Portion of Pivotal Phase 3 GRACE Trial in Patients With Cushing’s Syndrome | ||
By: GlobeNewswire - 22 Apr 2024 | Back to overview list |
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MENLO PARK, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- 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 positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective cortisol modulator relacorilant in patients with all etiologies of endogenous Cushing’s syndrome (hypercortisolism). 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. Open-Label Results “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.” Hypertension Hyperglycemia 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: <0.0001, 0.03, 0.03, respectively). During the open-label phase, 50 percent of patients with hyperglycemia met the study’s response criteria. For the patients that entered the randomized withdrawal phase, the observed improvements in hyperglycemia were even greater, with improvements in mean AUCglucose of 6.2 h*mmol/L, mean HbA1c of 0.7 percent and mean fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001, <0.0001, 0.006, respectively). See Figures 3 and 4. Other Cushing’s Syndrome Symptoms Safety About Relacorilant About Corcept Therapeutics Forward-Looking Statements 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. CONTACT Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/2f9e4e2a-2040-4584-8eba-2772419821e5 https://www.globenewswire.com/NewsRoom/AttachmentNg/5239830e-f4d9-43b4-a5d1-6f36d5efe615 https://www.globenewswire.com/NewsRoom/AttachmentNg/1a9a922c-0049-430e-93e9-d8522f224e8a https://www.globenewswire.com/NewsRoom/AttachmentNg/f0c4cf20-f155-4af0-9031-e38c27a08784 |
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