Metacrine Updates IBD Clinical Development Strategy and Implements Restructuring Plan
11 2월 2022 - 10:05PM
Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical
company pioneering differentiated therapies for patients with
gastrointestinal and liver diseases, today announced that it
remains on track to begin a Phase 2 clinical trial in ulcerative
colitis. Metacrine has received authorization from the U.S. Food
and Drug Administration (FDA) to proceed with its Phase 2 trial
evaluating MET642 in subjects with inflammatory bowel disease (IBD)
and expects to begin the study in the first half of 2022.
To support ongoing clinical development of MET642 in IBD, the
Company is implementing a restructuring plan to significantly
reduce expenses associated with its operations in order to preserve
cash. The restructuring includes a staff reduction of approximately
50% primarily consisting of the Company’s research organization. As
a result, Metacrine has also discontinued preclinical development
of its hydroxysteroid dehydrogenase (HSD) program. Cash, cash
equivalents and short-term investments were an estimated $76.4
million as of December 31, 2021. Metacrine believes it has
sufficient capital to fund its current operating plan through
2023.
“We are now focusing all of our development effort on bringing
expanded therapeutic options to people living with IBD,” said
Preston Klassen, M.D., MHS, CEO, Metacrine. “We have generated
preclinical data that supports moving our MET642 program into
clinical testing in IBD during the next few months. The rationale
for FXR-based therapies in IBD is anchored on the potential to
address multiple aspects of IBD pathogenesis without the
immunosuppression inherent to other advanced-line therapies. FXR is
highly expressed by intestinal epithelial cells and plays a key
role in healthy intestinal function by maintaining the epithelial
barrier, reducing bacterial translocation into the intestinal wall
and regulating the innate immune response. FXR therapy could bring
an oral, once-daily, well-tolerated and non-immunosuppressive
medicine to patients.”
Klassen continued, “We’re also taking restructuring steps to
manage our resources and significantly extend our cash runway as we
evaluate a range of ways to generate value from our discovery
programs, product candidates and financial assets. I am grateful
for the dedication of my fellow colleagues to our mission and thank
them for their many contributions over the last several years.”
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company
building a pipeline of differentiated therapies to treat
gastrointestinal and liver 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. 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 Metacrine’s plans and
timing for initiating future clinical trials and studies; the
expected benefits of its restructuring plans, including expected
cost savings provided by the restructuring; anticipated near and
long term drivers of value; estimates for its cash, cash
equivalents and short-term investments balance as of December 31,
2021; and its belief that it has sufficient capital to fund its
current operating plan through 2023. 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 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; Metacrine’s ability
to obtain, maintain and protect its intellectual property; and
Metacrine’s ability to successfully implement its restructuring
plans, including expected cost savings provided by the
restructuring. 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, 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
Investor Relations
Metacrine, Inc.
investors@metacrine.com
Metacrine (NASDAQ:MTCR)
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