Corcept Initiates MONARCH – A Phase 2b Trial in Non-Alcoholic Steatohepatitis (NASH)
26 Outubro 2023 - 5:05PM
Corcept Therapeutics Incorporated (NASDAQ: CORT), a
commercial-stage company engaged in the discovery and development
of medications to treat severe endocrine, oncology, metabolism, and
neurology disorders by modulating the effects of the hormone
cortisol, today announced it has initiated MONARCH, a Phase 2b
trial of its proprietary selective cortisol modulator miricorilant
in patients with non-alcoholic steatohepatitis (NASH).
MONARCH is a 150-patient, randomized,
double-blind, placebo-controlled study evaluating the efficacy and
safety of miricorilant in adult patients with biopsy-confirmed
NASH. Patients will receive either 100 mg of miricorilant or
placebo orally twice weekly for 48 weeks. The primary endpoint is
reduction in liver fat, with NASH resolution and fibrosis
improvement as key secondary endpoints.
“We are excited to initiate the MONARCH study
and to build on the promising results of our Phase 1b study, which
demonstrated that miricorilant effectively reduces liver fat,
improves liver health and key metabolic and lipid measures and is
well-tolerated. Miricorilant has the potential to greatly benefit
the millions of patients with NASH. We look forward to sharing more
details about MONARCH at the upcoming AASLD conference,” says Bill
Guyer, PharmD, Corcept’s Chief Development Officer.
About NASH
Non-alcoholic steatohepatitis (NASH) is an
advanced form of non-alcoholic fatty liver disease (NAFLD) that
afflicts millions of patients and is a leading cause of
liver-related mortality. Cortisol modulation may serve as a
treatment for NASH since cortisol activity at the glucocorticoid
receptor and mineralocorticoid receptor has been implicated in the
development and progression of NAFLD. There are no current
medications approved to treat NASH.
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 development of
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 timing and substance of our
Phase 2b trial in patients with NASH and the development of
miricorilant as a treatment for NASH, including its clinical
attributes, regulatory approvals, mandates, oversight, and other
requirements. We disclaim any intention or duty to update
forward-looking statements made in this press release.
CONTACTInvestor
inquiries:ir@corcept.comMedia
inquiries:CorceptCommunications@corcept.com www.corcept.com
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