Corcept Therapeutics' FDA-Approved Korlym Hits Main Goal In Cushing's Syndrome Patients With Difficult-To-Control Diabetes

On Thursday, Corcept Therapeutics Incorporated CORT said that the primary endpoint was met in the treatment phase of CATALYST, a randomized, double-blind, placebo-controlled study of Korlym in patients with hypercortisolism (Cushing’s syndrome) and difficult-to-control type 2 diabetes.

Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue, and weak muscles.

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CATALYST is a prospective Phase 4 study with two parts. The first part assessed the prevalence of hypercortisolism by screening 1,057 patients with difficult-to-control type 2 diabetes, defined as hemoglobin A1c greater than 7.5% despite receiving optimal therapies, including GLP-1 agonists.

The primary endpoint was the reduction in hemoglobin A1c between these groups. CATALYST met its primary endpoint.

Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, with a decrease from baseline of 1.47% compared to a decrease of 0.15% in patients who received a placebo.

Complete results from CATALYST will be presented at a medical conference next year.

The safety profile of Korlym was consistent with the medication’s label, and no new side effects or adverse events were identified.

In February 2012, the company introduced Korlym, the first medication approved by the FDA to treat patients with endogenous hypercortisolism.

Price Action: CORT stock traded higher by 2.09% at $57.50 premarket at the last check Friday.

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