Enrollment is underway in a Phase 3 clinical trial, GRADIENT, evaluating Corcept Therapeutics’ (NASDAQ:CORT) relacorilant in patients with Cushing’s syndrome (excessive levels of cortisol in the blood) caused by adrenal adenomas (adrenal gland tumors) or hyperplasia (enlarged glands), a type of Cushing’s representing ~15% of total cases.
The primary endpoints of the 130-subject study are safety, the change from baseline in 24-hour ambulatory blood pressure at week 22 versus placebo and, in participants with diabetes or impaired glucose tolerance, the mean change in area-under-the-curve (AUC) glucose at week 22 versus placebo.
The estimated completion date is June 2021.
Another Phase 3, GRACE, assessing relacorilant in 130 patients with all etiologies of Cushing’s syndrome is ongoing.
The company says the value proposition of relacorilant, a cortisol modulator, is equivalent efficacy to Korlym (mifepristone) without the unwanted side effects such as endometrial thickening, vaginal bleeding and hypokalemia (low blood potassium).
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