Corcept Therapeutics Incorporated (NASDAQ: CORT) has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its selective cortisol modulator, Relacorilant, as a treatment for patients with endogenous hypercortisolism, also known as Cushing’s syndrome. The NDA is supported by positive results from the pivotal Grace trial and confirmatory evidence from the Phase 3 Gradient and long-term extension studies, as well as a Phase 2 study in hypercortisolism.
Patients who received Relacorilant in these studies experienced improvements in a wide array of hypercortisolism's signs and symptoms, with an acceptable safety burden. Notably, there were no instances of drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, serious adverse events that can arise in patients taking currently approved medications. Additionally, there were no adverse events associated with activity at the progesterone receptor, such as endometrial thickening or vaginal bleeding.
Dr. Joseph Belanoff, Corcept’s Chief Executive Officer, expressed optimism about Relacorilant's potential to become the standard of care for the medical treatment of patients with hypercortisolism, emphasizing the combination of efficacy and safety that the drug offers.
Relacorilant, a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body’s other hormone receptors, is also being studied in a variety of serious disorders in addition to endogenous hypercortisolism, including ovarian, adrenal, and prostate cancer. The drug is proprietary to Corcept and is protected by composition of matter, method of use, and other patents. Furthermore, it has orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome.
Hypercortisolism, caused by excessive activity of the hormone cortisol, can lead to various symptoms such as hypertension, central obesity, elevated blood sugar, difficult-to-control type 2 diabetes, severe fatigue, and weak muscles. It can affect every organ system and can be lethal if not treated effectively.
Corcept Therapeutics, with a focus on cortisol modulation, has discovered more than 1,000 proprietary selective cortisol modulators over the past 25 years. The company is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease. In February 2012, Corcept introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. Today the company's shares have moved -1.0% to a price of $50.36. For more information, read the company's full 8-K submission here.
