Corcept Therapeutics Initiates CATALYST Clinical Trial
Corcept Therapeutics Incorporated recently announced it has initiated CATALYST, a 1,000-patient, Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes. Those patients with hypercortisolism will be offered entry into a randomized, double-blind, placebo-controlled study of Korlym.
“We are excited that our CATALYST trial is now open,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Many smaller studies conducted over the last fifteen years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in CATALYST, which will be the largest study of its kind ever to be conducted. Data from CATALYST will enable physicians to better identify and care for these patients. We expect to complete enrollment by the end of this year.”
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.
Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive US and foreign intellectual property covering both their composition and their use to treat a variety of serious disorders. Clinical trials are being conducted with the company’s leading selective cortisol modulators as potential treatments for patients with serious disorders – Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS, post-traumatic stress disorder and liver disease. Corcept’s drug Korlym was the first medication approved by the US FDA for the treatment of patients with Cushing’s syndrome.
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