Metacrine Achieves Full Enrollment for MET642 Phase 2a Trial in Patients With Nash
2021年9月9日 - 9:05PM
Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical
company pioneering differentiated therapies for patients with liver
and gastrointestinal diseases, today announced that it has
completed enrollment for its Phase 2a trial evaluating MET642, an
optimized farnesoid X receptor (FXR) agonist, in patients with
non-alcoholic steatohepatitis (NASH). The Company plans to report
interim data from the first 60 patients early in the fourth quarter
of 2021.
“As a potentially best-in-class FXR agonist, MET642 has
motivated investigators, and most importantly patients, to
participate in our study despite a challenging Covid-19
environment,” said Hubert C. Chen, M.D., chief medical officer,
Metacrine. “Thanks to the diligent work of our clinical operations
team and partners, we are just a few weeks away from announcing the
MET642 interim results, which would enable initiation of a liver
biopsy study in NASH and a proof-of-concept study in IBD in the
first half of 2022.”
The Phase 2a study (NCT04773964) is a 16-week, randomized,
placebo-controlled, multi-center trial evaluating the safety,
tolerability and pharmacological activity of MET642, as measured by
reductions in liver fat content with magnetic resonance
imaging-derived proton density fat fraction (MRI-PDFF), changes in
liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels
and incidence of pruritis, at 3 mg and 6 mg dose levels.
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company
building a pipeline of differentiated therapies to treat liver and
gastrointestinal diseases. Metacrine has developed a proprietary
farnesoid X receptor (FXR) platform utilizing a unique chemical
scaffold, which has demonstrated an improved therapeutic profile in
clinical trials. The Company’s two product candidates, MET409 and
MET642, are currently being investigated in clinical trials as
potential new treatments for NASH. MET409 has completed a 12-week
monotherapy trial in patients with NASH and is being evaluated in a
12-week combination trial with empagliflozin in patients with both
NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1
trial in healthy volunteers and is being evaluated in a 16-week
monotherapy trial in patients with NASH. To learn more, visit
www.metacrine.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Statements in this press release that are not purely
historical are forward-looking statements. Such forward-looking
statements include, among other things, statements about the
design, progress, timing, scope and results of clinical trials; the
anticipated timing of disclosure of results of clinical trials;
plans for initiating future clinical trials and studies; statements
regarding the therapeutic potential of MET409 and MET642; the
differentiated nature of Metacrine’s FXR program; plans for
advancing the clinical development of Metacrine’s FXR program; the
potential best-in-class nature of Metacrine’s FXR program; and the
potential for its FXR product candidates to be long-term therapies
for NASH and IBD. Words such as “may,” “will,” “expect,” “plan,”
“aim,” “projected,” “likely,” ”anticipate,” “estimate,” “intend,”
“potential,” “prepare,” “perceived,” “believes” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. These forward-looking
statements are based on Metacrine’s expectations and assumptions
that may never materialize or prove to be incorrect. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from those projected in any
forward-looking statements due to numerous risks and uncertainties,
including but not limited to: risks and uncertainties regarding
regulatory approvals for MET409 or MET642; potential delays in
initiating, enrolling or completing any clinical trials; potential
adverse side effects or other safety risks associated with
Metacrine’s product candidates; competition from third parties that
are developing products for similar uses; and Metacrine’s ability
to obtain, maintain and protect its intellectual property.
Information regarding the foregoing and additional risks may be
found in the section entitled “Risk Factors” in Metacrine’s
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (the “SEC”) on August 12, 2021, and in
Metacrine’s other filings with the SEC. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Except as required by law, Metacrine
assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
Investor & Media Contact
Steve Kunszabo
Metacrine, Inc.
+1 (858) 369-7892
skunszabo@metacrine.com
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