Corcept Announces Preliminary Results From Prevalence Phase Of CATALYST Clinical Trial
February 15 2024 - 4:02PM
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 preliminary results from the prevalence
phase of its ongoing CATALYST study of Cushing’s syndrome
(hypercortisolism) in patients with difficult-to-control type 2
diabetes. With a planned enrollment of 1,000 patients, CATALYST is
the largest study ever conducted to establish the prevalence of
hypercortisolism in this patient population.
Of the first 700 patients enrolled in CATALYST,
24 percent were identified as having hypercortisolism – a
prevalence rate that has been consistent throughout the study.
Final results from the prevalence phase will be presented at the
American Diabetes Association’s 84th Scientific Sessions in
June.
“These results are very powerful. While
cortisol’s role in diabetes is well understood, most diabetes care
providers have not considered hypercortisolism as a source of the
disease for their patients with difficult-to-control diabetes.
These preliminary results clearly indicate that hypercortisolism
should be considered – as the prevalence rate is significantly
higher than previously assumed,” said Ralph DeFronzo, MD, chief of
the Diabetes Division and professor of medicine at UT Health San
Antonio and CATALYST study investigator. “We look forward to seeing
the full results of this study, as they will guide physicians to
better identify patients with hypercortisolism and make informed
treatment decisions to prevent the serious and deadly complications
associated with the disease.”
“We look forward to advancing this landmark
study to completion,” said Bill Guyer, PharmD, Corcept’s Chief
Development Officer. “We deeply appreciate the investigators and
patients participating in CATALYST. Almost all of the patients
identified as suffering from hypercortisolism currently go
undiagnosed. We expect that CATALYST’s findings will lead to more
accurate diagnoses – and ultimately treatment – for this vulnerable
population.”
About the Phase 4 CATALYST
Study
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 therapies. 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. CATALYST is being
conducted at 35 sites in the United States.
About Corcept Therapeutics
For 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 Statements
Statements 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 final
results regarding 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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