Metacrine Announces FDA Fast Track Designation for MET642 as a Treatment of NASH
January 19 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 U.S. Food & Drug Administration (FDA)
has granted Fast Track designation to MET642, the company’s second
farnesoid X receptor (FXR) agonist, for the treatment of
non-alcoholic steatohepatitis (NASH).
“We are pleased to have received a second fast track designation
for product candidates from our proprietary FXR platform and
believe this further demonstrates the recognition of significant
unmet needs in patients with NASH by regulatory authorities,” said
Hubert C. Chen, M.D., chief medical officer of Metacrine. “Given
our recently reported, favorable Phase 1 data for MET642, we are
excited about its potential and look forward to advancing it into
the Phase 2a study in the first half of this year.”
Fast Track is a process designed to facilitate the development
and expedite the review of drugs designed to treat serious diseases
or conditions that have the potential to fill an unmet medical need
for such diseases or conditions. Through the Fast Track
designation, the company may be eligible to submit sections of its
New Drug Application on a rolling basis, and there are
opportunities for more frequent interactions and written
communications with the FDA around the drug’s development plan. A
Fast Track-designated product may also be eligible for accelerated
approval and priority review if the criteria for those programs are
satisfied.
Metacrine recently completed a Phase 1 clinical trial of MET642
in healthy volunteers, in which MET642 was safe and generally
well-tolerated and demonstrated a sustained pharmacokinetic profile
and robust FXR target engagement after 14 days of daily oral
dosing. Importantly, pruritus and LDL-cholesterol increases were
not seen at any dose level. The company plans to further evaluate
MET642 in a Phase 2a, 16-week, randomized, placebo-controlled trial
in patients with NASH, which is expected to begin in the first half
of 2021.
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 MET642; 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 MET642; 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,” “look forward,” “will,” “expect,” “plan,”
“estimate,” “intend,” “potential,” 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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