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 positive results from the
open-label portion of the pivotal Phase 3 GRACE trial of its
proprietary selective cortisol modulator relacorilant in patients
with all etiologies of endogenous Cushing’s syndrome
(hypercortisolism).
GRACE has two parts. In the “open-label” phase,
152 patients with Cushing’s syndrome and either hypertension,
hyperglycemia or both received relacorilant for 22 weeks. Patients
who exhibited pre-specified improvements in either or both symptoms
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’s primary endpoint is maintenance of blood
pressure control in the “randomized withdrawal” phase, with
maintenance of glycemic control as the key secondary endpoint.
Other key secondary and exploratory endpoints in the randomized
withdrawal phase include changes in weight, waist circumference,
cognitive impairment and Cushing’s Quality of Life score. The data
provided below are from GRACE’s open-label phase.
Open-Label ResultsPatients in
the open-label phase exhibited clinically meaningful and
statistically significant improvements in hypertension,
hyperglycemia and other key secondary and exploratory endpoints.
The drug was well-tolerated, consistent with relacorilant’s known
safety profile. Due to relacorilant’s unique mechanism of action,
the observed efficacy was seen without increases in cortisol
concentrations and relacorilant-induced hypokalemia. In addition,
no cases of relacorilant-induced endometrial hypertrophy with or
without vaginal bleeding were seen, nor were there any instances of
adrenal insufficiency or QT prolongation (independently
confirmed).
“These open-label results are compelling, and
they provide important information about the treatment of
hypercortisolism,” said Richard Auchus, MD, PhD, Professor of
Internal Medicine, Division of Metabolism, Endocrinology &
Diabetes at the University of Michigan and Chief of the
Endocrinology & Metabolism Section at the Ann Arbor VA Medical
Center. “Patients showed marked improvement across a broad range of
signs and symptoms, without significant safety burden. Due to
relacorilant’s unique mechanism of action, we are not observing
other toxicities seen with current therapies, which positions
relacorilant to potentially become a new standard of care for
patients with this disease.”
“These data improve on the results we observed
in our Phase 2 study,” said Bill Guyer, PharmD, Corcept’s Chief
Development Officer. “Cushing’s syndrome has many signs and
symptoms, which is why it is so important that patients in GRACE’s
open-label phase exhibited improvements across a broad range of
clinically meaningful endpoints. We expect to build on these
results in the trial’s randomized withdrawal phase. We plan to
present data from the open-label and randomized withdrawal phases
at a medical conference in June and remain on track to submit our
NDA this quarter.”
HypertensionRapid and sustained
improvements in systolic blood pressure (SBP) and diastolic blood
pressure (DBP) were observed in all patients with hypertension,
with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm
Hg at 22 weeks (p-values: <0.0001). During the open-label phase,
63 percent of patients with hypertension met the study’s response
criteria. For the patients that entered the randomized withdrawal
phase, the observed improvements in hypertension were even greater,
with improvements in mean SBP of 12.6 mm Hg and mean DBP of 8.3 mm
Hg at 22 weeks (p-values: <0.0001). To ensure accuracy,
hypertension was measured by 24-hour ambulatory blood pressure
monitoring (ABPM). See Figures 1 and 2.
HyperglycemiaGlucose metabolism
was measured by several diagnostic tests, including the oral
glucose tolerance test (glucose area under the curve or
AUCglucose), hemoglobin A1C (HbA1c) and fasting glucose.
Clinically meaningful and statistically
significant improvements in glucose metabolism were observed for
all patients with hyperglycemia, which includes patients with
diabetes and impaired glucose tolerance (pre-diabetes). Data showed
improvements in mean AUCglucose of 3.3 h*mmol/L, mean HbA1c of 0.3
percent and mean fasting glucose of 12.4 mg/dL at 22 weeks
(p-values: <0.0001, 0.03, 0.03, respectively). During the
open-label phase, 50 percent of patients with hyperglycemia met the
study’s response criteria. For the patients that entered the
randomized withdrawal phase, the observed improvements in
hyperglycemia were even greater, with improvements in mean
AUCglucose of 6.2 h*mmol/L, mean HbA1c of 0.7 percent and mean
fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001,
<0.0001, 0.006, respectively). See Figures 3 and 4.
Other Cushing’s Syndrome
SymptomsStatistically significant improvements in other
symptoms of Cushing’s syndrome, including body weight, waist
circumference, cognition (as assessed by the Trail Making Test) and
Cushing’s Quality of Life score, were observed in all patients
during the open-label phase of the study (all p-values:
<0.0001).
SafetyRelacorilant was well
tolerated. The most common adverse events were mild-to-moderate
nausea, edema, pain in extremities and back, and fatigue, which are
symptoms consistent with the “cortisol withdrawal” many patients
experience following surgery or initiation of medical therapy to
treat hypercortisolism. There were no increases in cortisol
concentrations and relacorilant-induced hypokalemia. In addition,
no cases of relacorilant-induced endometrial hypertrophy with or
without vaginal bleeding, adrenal insufficiency or QT prolongation
(independently confirmed) were reported.
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,
including ovarian, adrenal and prostate cancer and Cushing’s
syndrome. 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 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 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, including its randomized
withdrawal phase, regulatory oversight of relacorilant, 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
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