Corcept Completes Enrollment in Pivotal Phase 3 Rosella Trial of Relacorilant in Patients With Platinum-Resistant Ovarian Cancer
April 08 2024 - 7:00AM
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 ROSELLA, a
pivotal Phase 3 trial of its proprietary selective cortisol
modulator relacorilant combined with nab-paclitaxel in patients
with recurrent, platinum-resistant ovarian cancer.
“Fully enrolling ROSELLA takes us a big step
closer to addressing the unmet medical need of women with
platinum-resistant ovarian cancer,” said Bill Guyer, PharmD,
Corcept’s Chief Development Officer. “Relacorilant has the
potential to become the standard of care for patients with this
devastating disease. We expect progression-free survival data,
ROSELLA’s primary endpoint, by the end of this year.”
The ROSELLA trial has the same design as
Corcept's positive Phase 2 study, in which patients who received
relacorilant intermittently – the day before, the day of and the
day after they received nab-paclitaxel – exhibited improvements in
progression-free survival, duration of response and overall
survival compared to patients who received nab-paclitaxel alone,
without an increased side effect burden. These results were
published in the Journal of Clinical Oncology in June 2023.
The ROSELLA trial enrolled 381 women at sites in
the United States, Europe, South Korea, Brazil, Argentina, Canada
and Australia. Patients were randomized 1:1 to receive either
relacorilant dosed intermittently with nab-paclitaxel or
nab-paclitaxel monotherapy. ROSELLA’s primary endpoint is
progression-free survival. Overall survival is a key secondary
endpoint.
About Platinum-Resistant Ovarian
CancerOvarian cancer is the fifth most common cause of
cancer death in women. Patients whose disease returns less than six
months after receiving platinum-containing therapy have
“platinum-resistant” disease. There are few treatment options and
median overall survival following recurrence is 12 months or less
with single-agent chemotherapy.1 In the United States,
approximately 20,000 women with platinum-resistant disease are
candidates to start a new therapy each year.
About RelacorilantRelacorilant
is a selective cortisol modulator that binds to the glucocorticoid
receptor (GR), 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.
About Corcept’s Oncology
ProgramsCortisol activity allows solid tumors that express
the GR to resist treatment. In some cancers, cortisol inhibits
cellular apoptosis — the tumor-killing effect many treatments are
meant to stimulate. In other cancers, cortisol activity promotes
tumor growth. Cortisol also suppresses the body’s immune response,
weakening the body’s ability to fight certain cancers. Modulating
cortisol’s activity may reduce these adverse effects and help
anti-cancer treatments achieve their intended effect.
Corcept is conducting clinical trials of its
proprietary compound, relacorilant, in combination with three
different anti-cancer treatments in patients with ovarian, adrenal
and prostate cancers.
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 the conduct, pace and outcome
of our Phase 3 ROSELLA trial in patients with ovarian cancer, as
well as the development of relacorilant as a treatment for other
solid tumors, Cushing’s syndrome and other indications, including
relacorilant’s clinical attributes, regulatory approvals, mandates,
oversight, and other requirements; the potential for relacorilant
plus nab-paclitaxel to become a standard of care for patients with
recurrent, platinum-resistant ovarian cancer or to otherwise meet
their unmet medical needs. We disclaim any intention or duty to
update forward-looking statements made in this press release.
1 Therapeutic Advances in Medical
Oncology (Luvero et al. 2014)
CONTACTInvestor
inquiries:ir@corcept.comMedia inquiries:communications@corcept.com
www.corcept.com
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