Corcept Announces Presentation of Results From Prevalence Phase of CATALYST Clinical Trial at American Diabetes Association’s Scientific Sessions
24 Junio 2024 - 3:15PM
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 84th 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
CenterSession: Prevalence of
Hypercortisolism in Difficult-to-Control Type 2
DiabetesSession Chair: Rodica Pop-Busui,
MDPresenters:
- 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 TherapeuticsFor
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
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 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.
CONTACTInvestor
inquiries:ir@corcept.comMedia inquiries:communications@corcept.com
www.corcept.com
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