Metacrine Announces Publication of MET409 NASH Proof-of-Concept Study Results in the Journal of Hepatology
February 16 2021 - 6:30AM
Metacrine, Inc. (Nasdaq: MTCR), a clinical-stage biopharmaceutical
company focused on discovering and developing differentiated
therapies for patients with liver and gastrointestinal diseases,
today announced that the Journal of Hepatology has published the
results from the company’s 12-week, randomized, placebo-controlled
Phase 1b study of MET409, the company’s lead farnesoid X receptor
(FXR) agonist, in patients with non-alcoholic steatohepatitis
(NASH).
“The publication of our Phase 1b study data in this highly
regarded, peer-reviewed journal further underscores the promise of
an optimized FXR to treat patients with NASH, a potentially
life-threatening liver disease with no approved treatments,” said
Hubert C. Chen, M.D., chief medical officer of Metacrine. “MET409
has demonstrated improvements in the efficacy and tolerability
profile for the FXR class. These findings highlight its potential
as both a front-line monotherapy and backbone of combination
therapies, including with anti-diabetic medications in patients
with both NASH and type 2 diabetes, who represent a patient segment
with significant unmet needs. We are excited about the broad
potential for MET409.”
Metacrine has developed a proprietary FXR platform utilizing a
unique chemical scaffold, which has demonstrated a differentiated
and improved therapeutic profile in the clinic. MET409 is a
once-daily, orally administered FXR agonist that is being evaluated
as both a monotherapy and a combination therapy for the treatment
of NASH. In the 12-week Phase 1b trial in patients with NASH,
MET409 (50 mg) achieved approximately 38% mean relative liver fat
reduction and was associated with a 16% overall pruritus rate, with
no discontinuations due to pruritus, and a 7% LDL-cholesterol
increase, findings that are favorable and perceived as
class-leading for FXR agonists.
About the PublicationThe Journal of Hepatology
article, entitled “A structurally optimized FXR agonist, MET409,
reduced liver fat content over 12 weeks in patients with
non-alcoholic steatohepatitis”, was published online on February
11, 2021. Authors include Stephen A. Harrison, M.D., University of
Oxford and Pinnacle Clinical Research; Mustafa R. Bashir, M.D.,
Duke University Medical Center; and Eric J. Lawitz, M.D.,
University of Texas Health San Antonio and Texas Liver
Institute.
About Non-alcoholic Steatohepatitis
(NASH)Non-alcoholic steatohepatitis, or NASH, is a liver
disease characterized by excess liver fat, inflammation and
fibrosis. In 2015, there were an estimated 17 million people in the
United States with NASH, which is expected to increase to an
estimated 27 million people by 2030. Left untreated, patients’
disease may progress to liver failure, which is life-threatening
without a successful liver transplant. NASH is expected to become
the leading cause for liver transplants in the United States.
Additionally, patients with NASH often present with metabolic
disease and other co-morbidities, which is likely to require
combination therapy. Currently, there are no approved therapies for
NASH.
About MetacrineMetacrine, Inc. (Nasdaq: MTCR)
is a clinical-stage biopharmaceutical company building a
differentiated pipeline of therapies to treat liver and
gastrointestinal (GI) diseases. Metacrine has developed a
proprietary farnesoid X receptor (FXR) platform utilizing a unique
chemical scaffold, which has demonstrated a differentiated and
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
non-alcoholic steatohepatitis (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 advanced
into a 16-week monotherapy trial in patients with NASH.
Forward-Looking StatementsThis 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. Forward-looking statements contained in
this press release include statements regarding the therapeutic
potential of MET409; statements regarding Metacrine’s timelines;
the differentiated nature of Metacrine’s FXR program; plans
underlying Metacrine’s clinical trials; plans for advancing the
clinical development of Metacrine’s FXR program; the potential for
its FXR product candidates to be long-term therapies for NASH; the
potential for its FXR product candidates to be used in combination
therapies with anti-diabetic medications; and the potential for its
FXR product candidates to be therapies for patients with both NASH
and type 2 diabetes. Many factors may cause differences between
current expectations and actual results, including unexpected
safety or efficacy data observed during preclinical or clinical
studies and uncertainties related to the regulatory approval path
for the NASH indication. Words such as “may,” “could,” “will,”
“encourage,” “expect,” “plan,” “aim,” “anticipate,” “estimate,”
“intend,” “potential,” “prepare” 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 November
12, 2020, 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.
Contact:Chelcie ListerTHRUST Strategic
Communications910.777.3049investors@metacrine.com
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