Monday, Corcept Therapeutics Incorporated (NASDAQ:CORT) released 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 could enter the trial's withdrawal phase.
No cases of relacorilant-induced endometrial hypertrophy with or without vaginal bleeding were seen, nor were there any instances of adrenal insufficiency or QT prolongation.
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: <0.0001).
During the open-label phase, 63% of patients with hypertension met the study's response criteria.
For the patients that entered the randomized withdrawal phase, the observed improvements in hypertension were even greater, with improvements in mean SBP of 12.6 mm Hg and mean DBP of 8.3 mm Hg at 22 weeks (p-values: <0.0001).
Clinically meaningful and statistically significant improvements in glucose metabolism were observed for all patients with hyperglycemia.
Data showed improvements in mean AUC glucose 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% 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).
Relacorilant was well tolerated. The most common adverse events were mild-to-moderate nausea, edema, pain in extremities and back, and fatigue.
"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," said Bill Guyer, Corcept's Chief Development Officer.
Price Action: CORT shares are down 1.94% at $22.50 on the last check Monday.