Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
31 December 2024 - 9:15AM
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, has submitted a new drug application (NDA) to the U.S.
Food and Drug Administration for its proprietary, selective
cortisol modulator, relacorilant, to treat patients with endogenous
hypercortisolism (Cushing’s syndrome).
Corcept’s NDA is based on positive results from the pivotal
GRACE trial and confirmatory evidence from the Phase 3 GRADIENT and
long-term extension studies and a Phase 2 study in
hypercortisolism. Patients in these studies who received
relacorilant experienced improvements in a wide array of
hypercortisolism’s signs and symptoms, with an acceptable safety
burden. Notably, there were no instances of drug-induced adrenal
insufficiency, hypokalemia or QT prolongation – serious adverse
events that can arise in patients taking currently approved
medications – and no adverse events associated with activity at the
progesterone receptor, such as endometrial thickening or vaginal
bleeding.
“Relacorilant’s combination of efficacy and safety give it the
potential to become the standard of care for the medical treatment
of patients with hypercortisolism,” said Joseph Belanoff, MD,
Corcept’s Chief Executive Officer. “Our commitment to the health of
patients with hypercortisolism is unwavering. We are optimistic
that relacorilant will be of great benefit to them.”
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the
glucocorticoid receptor but not to the body's other hormone
receptors. Corcept is studying relacorilant in a variety of serious
disorders in addition to endogenous hypercortisolism (Cushing’s
syndrome), including ovarian, adrenal and prostate cancer.
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 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
statements concerning: the results of our Phase 2, GRACE, GRADIENT,
and long-term extension studies; relacorilant’s efficacy, safety
and other clinical attributes and its potential to receive
regulatory approval and become a standard-of-care treatment for
patients with endogenous hypercortisolism; regulatory oversight of
relacorilant and the scope, pace and outcome of its NDA submission;
relacorilant’s acceptance and use by physicians and patients and
its commercial prospects; and the scope and protective power of
relacorilant’s orphan drug designation and our intellectual
property. We disclaim any intention or duty to update
forward-looking statements made in this press release.
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