Corcept Completes Enrollment in Phase 4 CATALYST Trial
29 Abril 2024 - 9:00AM
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 CATALYST, a
Phase 4 trial examining the prevalence of hypercortisolism
(Cushing’s syndrome) in patients with difficult-to-control type 2
diabetes; patients with hypercortisolism may enter a randomized,
placebo-controlled study of Korlym®.
“With a total enrollment of more than 1,000
patients, CATALYST is the largest study ever conducted to establish
the prevalence of hypercortisolism in this patient population,”
said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Approximately 25 percent of the patients enrolled in CATALYST were
identified as having hypercortisolism – which is substantially
higher than previously assumed for this group. We look forward to
sharing final prevalence data at the American Diabetes
Association’s 84th Scientific Sessions in June and treatment data
by year-end. We expect that the findings from CATALYST will guide
physicians to better identify and treat patients with
hypercortisolism.”
CATALYST is a prospective, Phase 4 study with
two parts. The prevalence phase assesses 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 treatment. Patients from this
group with a dexamethasone suppression test value greater than 1.8
µg/dL and dexamethasone levels greater than 140 ng/dL are
identified as having hypercortisolism. Subject to satisfying
additional screening criteria, these patients are eligible to enter
CATALYST’s treatment phase, in which they are randomized, 2:1, to
receive treatment with either Korlym or placebo for 24 weeks.
CATALYST is being conducted at 35 sites in the United States.
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 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: 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.comwww.corcept.com
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