Company Announcements

• Results from the CATALYST clinical trial were presented at the American Diabetes Association’s 84^th Scientific Sessions at a featured plenary session titled: “Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes”
• With 1,055 patients enrolled, CATALYST is the largest and most rigorous study ever conducted to assess the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes
• Results demonstrate a hypercortisolism prevalence rate of 24 percent in this patient population
  

MENLO PARK, Calif., June 24, 2024 (GLOBE NEWSWIRE) -- 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 that results from the prevalence phase of its CATALYST study of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control type 2 diabetes were presented at the American Diabetes Association’s 84^th Scientific Sessions.

CATALYST enrolled 1,055 patients across 36 sites in the U.S., making it the largest and most rigorous study ever conducted to assess the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Of the patients enrolled in CATALYST, 24 percent were identified as having hypercortisolism. Hypercortisolism was more common in patients with cardiovascular disease, particularly in those who needed multiple medications to manage their hypertension. It was also more common in those taking more medication to manage their diabetes.

“Until now, hypercortisolism has been widely regarded as extremely rare. But that turns out not to be true. These results show that hypercortisolism among patients with difficult-to-control type 2 diabetes is much more common than previously assumed and is likely the underlying cause of diabetes in many cases,” said Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. “These insights should lead to expanded screening for hypercortisolism, more effective treatment and better health outcomes for patients who are struggling today."

“Physicians haven’t been looking for hypercortisolism in their patients with difficult-to-control type 2 diabetes because they didn’t know how common it is,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “These data will enable physicians to more accurately diagnose and treat patients with hypercortisolism - a serious and deadly disease.”

CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assessed 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, including GLP-1 agonists. Patients from this group with a dexamethasone suppression test (DST) value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL were identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients were eligible to enter CATALYST’s treatment phase, in which they were randomized, 2:1, to receive treatment with either Korlym^® or placebo. Results of the treatment phase will be available by year-end.

Additional details about the presentation are as follows:

American Diabetes Association 84th Scientific Sessions, Orange County Convention Center
Session: Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes
Session Chair: Rodica Pop-Busui, MD
Presenters:

• The Spectrum of Hypercortisolism: An Evolution of Understanding – Richard Auchus, MD
• Pathologic Mechanisms of Hypercortisolism in Type 2 Diabetes – Ralph DeFronzo, MD
• Rationale for and Design of the CATALYST Trial – Athena Philis-Tsimikas, MD
• Results of the CATALYST Trial Part 1 – Vivian Fonseca, MD
• Clinical Implications of the CATALYST Trial Part 1 – John Buse, MD
  

About Hypercortisolism (Cushing’s Syndrome)
Hypercortisolism is caused by excessive activity of the endogenous hormone cortisol. Symptoms of hypercortisolism vary, but most patients experience one or more of the following manifestations: elevated blood sugar, difficult-to-control type 2 diabetes, hypertension, central 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.

About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease. 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 expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym^®, relacorilant, miricorilant, dazucorilant and our other product candidates, as well as those molecules’ 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 results of 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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