Corcept Completes Enrollment in Phase 3 Gradient Trial of Relacorilant in Patients With Adrenal Cushing’s Syndrome
01 Aprile 2024 - 2:00PM
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 completion of enrollment in GRADIENT, a
Phase 3 trial of its proprietary selective cortisol modulator
relacorilant in patients with Cushing’s syndrome (hypercortisolism)
caused by an adrenal adenoma or adrenal hyperplasia.
“Hypercortisolism with adrenal etiology affects
many patients and is associated with serious cardiometabolic
comorbidities, including hypertension and hyperglycemia, and
increased risk of premature death,” said Bill Guyer, PharmD,
Corcept’s Chief Development Officer. “GRADIENT is the first
prospective placebo-controlled study to be conducted exclusively in
these patients with Cushing’s syndrome. We expect data from
GRADIENT in the fourth quarter of this year.”
GRADIENT is a randomized, double-blind,
placebo-controlled trial conducted at sites in the United States,
Europe and Israel. One-hundred thirty-seven patients were
randomized 1:1 to receive relacorilant or placebo for 22 weeks.
Primary endpoints are improvement in glucose metabolism and
hypertension.
About Cushing’s Syndrome
(Hypercortisolism)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. 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. Cushing’s syndrome can affect every
organ system and can be lethal if not treated effectively.
About RelacorilantRelacorilant
is a selective cortisol modulator that binds to the glucocorticoid
receptor (GR), but does not bind to the body's other hormone
receptors. Corcept is studying relacorilant in a variety of serious
disorders, including ovarian, adrenal and prostate cancer and
Cushing’s syndrome. Relacorilant is proprietary to Corcept and is
protected by composition of matter, method of use and other
patents. Relacorilant has orphan drug designation in the United
States and the European Union for the treatment of Cushing’s
syndrome.
About Corcept TherapeuticsFor
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
StatementsStatements 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 those concerning the development of relacorilant
as a treatment for Cushing’s syndrome, and design, timing and
expectations regarding our GRADIENT trial. We disclaim any
intention or duty to update forward-looking statements made in this
press release.
CONTACTInvestor
inquiries:ir@corcept.comMedia inquiries:communications@corcept.com
www.corcept.com
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