Corcept Therapeutics Initiates MOMENTUM Trial to Determine Prevalence of Hypercortisolism in Patients with Resistant Hypertension

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- 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 the initiation of MOMENTUM, a clinical trial examining the prevalence of endogenous hypercortisolism (Cushing’s syndrome) in patients with resistant hypertension.

The MOMENTUM trial, which will enroll 1,000 patients across 45 sites in the U.S., will establish the prevalence of endogenous hypercortisolism in patients with resistant hypertension. Resistant hypertension is defined by the American Heart Association as elevated blood pressure despite the use of three or more antihypertensive medications in different classes, including a diuretic. Patients with a dexamethasone suppression test (DST) value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL will be identified as having hypercortisolism and will undergo additional testing and adrenal imaging.

MOMENTUM’s design is similar to Corcept’s CATALYST clinical trial, which demonstrated that one in four patients with difficult-to-control type 2 diabetes has hypercortisolism. The trial results also showed that hypercortisolism was even more common in patients who also had cardiovascular disease, particularly in those who needed three or more medications to manage their hypertension.

“Resistant hypertension is a serious public health challenge. Patients whose hypertension remains in poor control despite receiving optimal care, including multiple medications, are at greater risk of cardiovascular morbidity and mortality,” said Deepak L. Bhatt, M.D., M.P.H., M.B.A., Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai. “We hope the data from this MOMENTUM trial will expand our understanding of the challenges these patients face and open up new opportunities for treatment.” Dr. Bhatt is a lead investigator and steering committee member for MOMENTUM and a paid consultant to Corcept Therapeutics.

“The MOMENTUM trial will provide a deeper understanding of hypercortisolism as a potential underlying issue for patients with resistant hypertension,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Establishing the prevalence of hypercortisolism in this patient population will help clinicians better understand and address their patients’ needs. We expect results from this study by year-end.”

About Hypercortisolism (Cushing’s Syndrome)

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. Irritability, anxiety, depression and cognitive disturbances are 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, 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 endogenous hypercortisolism. Corcept is headquartered in Redwood City, 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 and 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 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, among others: the design, timing, results and expectations regarding our MOMENTUM trial. We disclaim any intention or duty to update forward-looking statements made in this press release.

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Source: Corcept Therapeutics Incorporated

FAQ

What is the primary objective of Corcept's MOMENTUM trial for CORT stock?

The trial aims to determine the prevalence of endogenous hypercortisolism in patients with resistant hypertension across 45 U.S. sites with 1,000 participants.

When will Corcept Therapeutics (CORT) release MOMENTUM trial results?

Results from the MOMENTUM trial are expected by year-end.

What were the findings of CORT's previous CATALYST trial?

The CATALYST trial found that 25% of patients with difficult-to-control type 2 diabetes have hypercortisolism, with higher rates in those needing 3+ hypertension medications.

What criteria will CORT's MOMENTUM trial use to identify hypercortisolism?

Patients with dexamethasone suppression test values >1.8 µg/dL and dexamethasone levels >140 ng/dL will be identified as having hypercortisolism.