Corcept's Relacorilant Shows Promise in Cushing's Syndrome Treatment
核心洞察
Corcept Therapeutics' GRADIENT trial demonstrates relacorilant's efficacy in treating Cushing's syndrome, showing clinically meaningful improvements in hypercortisolism (搜索) signs and symptoms.
The Phase 3 trial supports the New Drug Application (NDA) for relacorilant, expected to be submitted by year-end, offering a potential new treatment option.
Relacorilant was well-tolerated in the GRADIENT study, with a safety profile consistent with previous trials, and no instances of hypokalemia or other severe adverse effects.
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 (搜索) 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 (搜索) 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 (搜索) and difficult-to-control type 2 diabetes, the ROSELLA study in women with platinum-resistant ovarian cancer (搜索), and the DAZALS study in patients with amyotrophic lateral sclerosis (ALS (搜索)).
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 (搜索).