Corcept Therapeutics has announced positive results from its Phase 3 GRADIENT trial, evaluating relacorilant for the treatment of Cushing's syndrome. The data supports the submission of a New Drug Application (NDA) to the FDA, planned for this quarter. The trial demonstrated clinically meaningful improvements in a range of hypercortisolism signs and symptoms in patients with Cushing's syndrome caused by adrenal gland pathology.
The GRADIENT trial, a randomized, double-blind, placebo-controlled study, involved 137 patients. Relacorilant was well-tolerated, with a safety profile consistent with the GRACE study. Notably, there were no cases of relacorilant-induced hypokalemia, endometrial hypertrophy or related vaginal bleeding, adrenal insufficiency, or QT prolongation.
Clinical Improvements
Patients treated with relacorilant exhibited statistically significant improvements in several key indicators:
- Systolic Blood Pressure (SBP): A reduction of 6.6 mm Hg (p-value: 0.012) was observed in patients with hypertension, measured by 24-hour ambulatory blood pressure monitoring.
- Glucose Metabolism: Improvements were seen in fasting glucose (placebo-adjusted reduction of 22.2 mg/dL; p-value: 0.002), area under the curve of the oral glucose tolerance test (placebo-adjusted reduction of 2.6 h*mmol/L; p-value: 0.046), and hemoglobin A1c (placebo-adjusted reduction of 0.3 percent; p-value: 0.019).
- Body Composition: Patients experienced a placebo-adjusted reduction of 3.9 kg in body weight (p-value: 0.0001), along with improvements in visceral adipose fat mass and volume (p-values: 0.018 and 0.016, respectively).
Bill Guyer, PharmD, Corcept’s Chief Development Officer, stated, "GRADIENT’s positive results in patients with Cushing’s syndrome confirm relacorilant’s promise as a significant medical advancement for the treatment of this deadly disease... These data will be a powerful addition to relacorilant’s NDA, which we plan to submit by year-end."
Financial Performance
Corcept also reported a strong financial performance, with third-quarter revenue of $182.5 million, a 48% increase compared to the same period in 2023. The company has increased its 2024 revenue guidance to $675 – $700 million.
Ongoing Clinical Programs
Corcept anticipates releasing data from other ongoing studies by year-end, including the CATALYST study in patients with Cushing’s syndrome and difficult-to-control type 2 diabetes, the ROSELLA study in women with platinum-resistant ovarian cancer, and the DAZALS study in patients with amyotrophic lateral sclerosis (ALS).
About Relacorilant
Relacorilant is a selective cortisol modulator being developed for the treatment of Cushing's syndrome and other disorders. It aims to address the unmet medical needs of patients who suffer from hypercortisolism.
