Metacrine to Present New Data from MET409 Program in NASH at AASLD’s The Liver Meeting Digital Experience™
October 01 2020 - 4:01PM
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 two posters highlighting new data on the
company’s lead clinical candidate, MET409, a farnesoid X receptor
(FXR) agonist for the treatment of non-alcoholic steatohepatitis
(NASH), will be presented at the American Association for the Study
of Liver Diseases’ (AASLD) The Liver Meeting Digital Experience™.
The virtual meeting is taking place Nov. 13-16, 2020.
“We are pleased to report new pharmacokinetic and
pharmacodynamic data from our MET409 Phase 1b proof-of-concept
clinical trial in patients with NASH, a prevalent and potentially
life-threatening condition for which there are no approved
treatments available today,” said Hubert C. Chen, M.D., chief
medical officer of Metacrine. “The findings demonstrated robust and
sustained FXR activation, which we believe is key to optimizing
therapeutic benefits. Combined with a favorable pharmacological and
tolerability profile, these results further highlight the
therapeutic potential of MET409 for patients with NASH. We look
forward to presenting these data, which support the continued
advancement of our FXR program, including both MET409 and our
second clinical candidate, MET642.”
In addition, new data generated in collaboration
with Dr. Mustafa R. Bashir, associate professor of Radiology and
associate professor in the Department of Medicine,
Gastroenterology, and colleagues at Duke University Medical Center,
show that relative liver fat content (LFC) reduction after four
weeks of treatment with MET409 was strongly predictive of LFC
reduction at week 12 in the proof-of-concept study. “These findings
suggest that early measurement of liver fat content may help guide
the long-term treatment strategy with FXR agonists in NASH,” said
Dr. Bashir.
Title: Dose-dependent changes in
pharmacokinetic and pharmacodynamic profiles of MET409, a sustained
FXR agonist, after 12 weeks of treatment in patients with NASH
Authors: E.J. Lawitz, K-J Lee, J. Shim-Lopez, J.
Lee, H.C. Chen Publication Number: 1669
Session Title: NAFLD and NASH: Therapeutics -
Pharmacologic and Other Key Findings: In a
12-week, randomized, double-blind, placebo-controlled study, 58
patients diagnosed with NASH were enrolled into three cohorts: 50
mg (n=19), 80 mg (n=20) and placebo (n=19). MET409 treatment
resulted in dose-dependent decreases in serum levels of C4, a
circulating biomarker of FXR target activity: 71-95% in trough
levels at day 84 relative to baseline, and 78-96% in day 84
area-under-the-curve (AUC) relative to placebo (p<0.05 for both
comparisons). These results demonstrate robust, sustained FXR
activation by MET409 and correlate with previously-reported
benefits of LFC reduction and improvement in liver chemistries.
Title: Change in liver fat
content at 4 weeks accurately predicts change in liver fat content
at 12 weeks in non-alcoholic steatohepatitis patients treated with
an FXR Agonist: Analysis from a 12-week, randomized,
placebo-controlled study with MET409 Authors: H.
Jiang, H.C. Chen, K.J. Lafata, M.R. Bashir Publication
Number: 1489 Session Title: NAFLD and
NASH: Diagnostics and Biomarkers Key Findings: As
previously reported, MET409 significantly lowered LFC at week 12,
with mean relative reductions of 55% (80 mg) and 38% (50 mg) vs. 6%
in placebo (p<0.001). MET409 achieved ≥30% relative LFC
reduction in 93% (80 mg) and 75% (50 mg) of patients vs. 11% in
placebo (p<0.001). Simple and multiple linear regression
analyses demonstrated that week 4 relative LFC reduction
(regression coefficient: 1.243, p<0.001) was a significant
predictor of week 12 LFC reduction. These findings suggest the
potential of early liver fat content assessment as an indicator of
long-term treatment response.
About Metacrine Metacrine, Inc.
(Nasdaq: MTCR) is a clinical-stage biopharmaceutical company
building a differentiated pipeline of therapies to treat liver and
gastrointestinal (GI) diseases. The company’s most advanced
programs, MET409 and MET642, target the farnesoid X receptor (FXR),
which is central to modulating liver and GI diseases. Both MET409
and MET642 are currently being investigated in clinical trials as
potential new treatments for non-alcoholic steatohepatitis
(NASH).
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “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 the company’s expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include statements regarding the therapeutic potential of
MET409, plans for advancing the clinical development of our FXR
program and the potential for our 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. Other factors that may cause
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
the company’s filings with the U.S. Securities and Exchange
Commission, including “Risk Factors” section of the company’s
prospectus dated September 15, 2020 filed pursuant to Rule
424(b)(4) with the Securities and Exchange Commission. Except as
required by law, the company 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 Lister THRUST
Strategic Communications 910-777-3049 investors@metacrine.com
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