Corcept Therapeutics Incorporated announced data from a Phase 3 study, which demonstrated that refractory Cushing’s syndrome patients receiving Corlux (mifepristone) experienced significant clinical and metabolic improvements over baseline measurements.
Corlux, a glucocorticoid receptor type II (GR-II) antagonist, has been granted Orphan Drug Designation for the treatment of endogenous Cushing’s syndrome by the U.S. Food and Drug Administration (FDA).
Fifty patients were enrolled in the study; 43 had Cushing’s disease (pituitary tumor), with 42 having prior surgery.
Four patients had ectopic ACTH-producing tumors and three had adrenal cancer. Forty-six of the patients completed at least 30 days of treatment and were included in the modified intent to treat group (mITT) for the efficacy analysis. Thirty-four patients completed the study.
There were 29 patients enrolled in the glucose intolerant group, and there was a continued improvement in glucose tolerance measured at each of the evaluations. Of the 12 patients taking insulin at baseline, seven cut their daily dose by at least 50%.
There were 21 patients enrolled in the hypertension group, of which 38% achieved a 5 mm or greater reduction in diastolic blood pressure without increasing the patient’s prescribed hypertensive medication. There were a total of 40 patients in the study with a diagnosis of hypertension, among them 17 had a decrease in diastolic blood pressure, and 21 patients had either decrease in diastolic blood pressure or a reduction in medications.
The data demonstrated that refractory Cushing’s Syndrome patients receiving Corlux experienced significant clinical and metabolic improvements over baseline measurements.
Corlux was well tolerated and enabled almost 50% of patients taking anti-diabetic, insulin and hypertensive medications at enrollment to reduce the dosage by study’s end.
Release Date: June 4, 2011
Source: Corcept Therapeutics Incorporated
Filed Under: Drug Discovery