Corcept Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism (Cushing’s Syndrome)
28 May 2024 - 10:00PM
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 that GRACE, the Phase 3 trial
of its proprietary selective cortisol modulator relacorilant in
patients with hypercortisolism (Cushing’s syndrome), met its
primary endpoint.
The GRACE study has two parts. On April 22,
Corcept announced that patients in GRACE’s initial, open-label
phase exhibited clinically meaningful and statistically significant
improvements in hypertension, hyperglycemia and other symptoms
experienced by patients with Cushing’s syndrome. Patients who
exhibited pre-specified improvements in hypertension, hyperglycemia
or both were given the opportunity to enter the trial’s randomized,
double-blind withdrawal phase, in which half of the patients
continued to receive relacorilant and half received placebo, for 12
weeks.
GRACE met its primary endpoint of loss of blood
pressure control in the randomized withdrawal phase among patients
receiving relacorilant as compared to placebo (odds
ratio: 0.17; p-value: 0.02). Consistent with its known safety
profile, relacorilant was well-tolerated in both phases of GRACE,
with no differences in the randomized withdrawal phase between the
relacorilant and placebo groups. Additional data will be presented
at the Endocrine Society (ENDO) annual meeting in Boston (poster
presentation, June 3) and the Heart in Diabetes (HiD) conference in
Philadelphia (oral presentation, June 7). The company expects to
submit its New Drug Application in the third quarter.
“The data from GRACE make a compelling case for
the use of relacorilant in patients with endogenous
hypercortisolism. That patients experienced clinically significant
improvements in hypertension, hyperglycemia and the other signs and
symptoms of Cushing’s syndrome, without significant safety burden,
is greatly encouraging for physicians and the patients they seek to
help,” said Rosario Pivonello, MD, PhD, Principal Investigator of
the GRACE study and Professor of Endocrinology at
Università Federico II di Napoli, Italy.
“GRACE’s clearly positive results are a welcome
development for patients and constitute a significant step toward
our new drug application for relacorilant,” said Bill Guyer,
PharmD, Corcept’s Chief Development Officer. “Patients receiving
relacorilant exhibited rapid and sustained improvements in
hypertension and were 5.9 times more likely to maintain their
hypertension response compared to patients receiving placebo. We
plan to present data from the open-label and randomized withdrawal
phases of GRACE at medical conferences in June.”
About RelacorilantRelacorilant
is a selective cortisol modulator that binds to the glucocorticoid
receptor but does not bind to the body's other hormone receptors.
Corcept is studying relacorilant in a variety of serious disorders
in addition to 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 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 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: relacorilant, including its
clinical attributes and potential to become a treatment for
patients with Cushing’s syndrome or any other disorder, the
conduct, pace and outcome of GRACE, regulatory oversight of
relacorilant, the timing of relacorilant’s NDA submission and its
prospects for approval by the FDA and other authorities,
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.
CONTACTInvestor
inquiries:ir@corcept.comMedia inquiries:communications@corcept.com
www.corcept.com
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From May 2024 to Jun 2024
Corcept Therapeutics (NASDAQ:CORT)
Historical Stock Chart
From Jun 2023 to Jun 2024