Metacrine Initiates Phase 2a Trial of MET642 for the Treatment of Patients with NASH
March 09 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 first patient has been treated in its
Phase 2a trial of MET642, a potent, sustained, non-bile acid
farnesoid x-receptor (FXR) agonist, for the treatment of patients
with non-alcoholic steatohepatitis (NASH).
“NASH is a devastating disease, for which an
optimized FXR agonist could play a foundational role in the
treatment paradigm,” said Hubert C. Chen, M.D., chief medical
officer of Metacrine. “MET642 has demonstrated an encouraging
profile - including sustained pharmacodynamic effects without
pruritus or low-density lipoprotein cholesterol increase - after 14
days of daily oral dosing in our Phase 1 study in healthy
volunteers. We are pleased to start this important proof-of-concept
study in patients with NASH and look forward to sharing interim
results in the fourth quarter of 2021.”
Metacrine has developed a proprietary FXR platform
utilizing a unique chemical scaffold, which has demonstrated a
clinically differentiated and improved therapeutic profile. The
company’s lead FXR clinical candidate, MET409, has successfully
completed a 12-week trial in patients with NASH. MET642 is derived
from the same chemical scaffold as MET409, with comparable FXR
target engagement and pharmacology in preclinical studies, while
demonstrating increased potency and differentiated pharmaceutical
properties relative to MET409.
The Phase 2a clinical trial is a 16-week,
randomized, placebo-controlled, multi-center trial evaluating the
safety, tolerability and pharmacological activity (as measured by
liver fat reduction) of MET642 (3 mg and 6 mg) vs placebo. An
interim analysis is planned in the fourth quarter of 2021, after
approximately 60 patients have completed 16 weeks of treatment.
Topline trial results of up to 180 patients are expected to be
reported in the first half of 2022.
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 evaluated
in 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 MET642; the differentiated nature of Metacrine’s FXR
program; plans underlying Metacrine’s clinical trials; anticipated
study timelines; plans for advancing the clinical development of
Metacrine’s FXR program; and the potential for its FXR product
candidates to be long-term therapies for NASH. 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:Steve
Kunszaboinvestors@metacrine.com
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