Corcept Announces Preliminary Results From Prevalence Phase Of CATALYST Clinical Trial

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced preliminary results from the prevalence phase of its ongoing CATALYST study of Cushing’s syndrome (hypercortisolism) in patients with difficult-to-control type 2 diabetes. With a planned enrollment of 1,000 patients, CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in this patient population.

Of the first 700 patients enrolled in CATALYST, 24 percent were identified as having hypercortisolism – a prevalence rate that has been consistent throughout the study. Final results from the prevalence phase will be presented at the American Diabetes Association’s 84th Scientific Sessions in June.

“These results are very powerful. While cortisol’s role in diabetes is well understood, most diabetes care providers have not considered hypercortisolism as a source of the disease for their patients with difficult-to-control diabetes. These preliminary results clearly indicate that hypercortisolism should be considered – as the prevalence rate is significantly higher than previously assumed,” said Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. “We look forward to seeing the full results of this study, as they will guide physicians to better identify patients with hypercortisolism and make informed treatment decisions to prevent the serious and deadly complications associated with the disease.”

“We look forward to advancing this landmark study to completion,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the investigators and patients participating in CATALYST. Almost all of the patients identified as suffering from hypercortisolism currently go undiagnosed. We expect that CATALYST’s findings will lead to more accurate diagnoses – and ultimately treatment – for this vulnerable population.”

About the Phase 4 CATALYST Study

CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assesses the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, which the study defines as hemoglobin A1c greater than 7.5 percent despite receiving optimal therapies. Patients from this group with a dexamethasone suppression test value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL are identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients are eligible to enter CATALYST’s treatment phase, in which they are randomized, 2:1, to receive treatment with either Korlym® or placebo. CATALYST is being conducted at 35 sites in the United States.

About Corcept Therapeutics

For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include: the design, timing, expectations and final results regarding our CATALYST trial and its impact on the medical field’s rate of screening for and treatment of hypercortisolism. We disclaim any intention or duty to update forward-looking statements made in this press release.

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