miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage
biopharmaceutical company focused on the discovery and development
of RNA-targeted therapies, announced today that it will report new
data demonstrating that systemic administration of its
second-generation microRNA-29 mimic, the Company’s pre-clinical
micro-RNA targeted therapeutic candidate for idiopathic pulmonary
fibrosis (“IPF”), efficiently reduced extracellular matrix
deposition in a series of preclinical studies. The data will
be presented today at the 2019 American Thoracic Society (“ATS”)
Conference in Dallas, TX.
“We are encouraged by the data presented from several in vivo
studies of our second-generation microRNA-29 mimic. These
data demonstrate efficacy in blunting the fibrotic response in the
bleomycin model of pulmonary fibrosis in mice,” said Paul Rubin,
M.D., Executive Vice President, R&D, of miRagen Therapeutics.
“Considering the data from these studies, we believe that our lead
compound has the potential to be efficacious in the treatment of
IPF when administered systemically at considerably lower doses
compared to other compounds we have tested in previous pre-clinical
studies.”
“These data coupled with previous observations in humans with
IPF support the role of microRNA-29 in pathologic fibrosis, as well
as the use of microRNA-29 replacements as potential therapeutics in
pulmonary fibrosis. I am very excited about the potential role of
miRagen’s microRNA-29 mimics, which is being facilitated by our
collaboration through the NIH-NHLBI funded CADET program,” stated
Naftali Kaminski, M.D., Boehringer-Ingelheim Endowed Professor of
Internal Medicine, Chief of Pulmonary, Critical Care and Sleep
Medicine, Department of Medicine, Yale School of Medicine.
In these studies, a chemically modified microRNA-29 replacement
was studied in mice with bleomycin-induced fibrosis in their lungs,
which is a well-established model of IPF. The compound was
evaluated in both therapeutic and prophylactic dosing
paradigms. Data from the studies demonstrated a
down-regulation of certain pro-fibrotic genes that were previously
established as targets of microRNA-29. These effects extended
to downstream targets involved in the pro-fibrotic response,
including connective tissue growth factor (CTGF). The
downregulation of these mechanistic biomarkers translated to the
significant inhibition of the pro-fibrotic response as measured by
quantitative histopathological analyses of whole lung scans.
This resulted in an approximately 50% inhibition of collagen
deposition. Additionally, animals treated with the compound
showed normal alveoli architecture, which was not present in
control mice.
The poster will be available on the scientific publications page
of the Company’s website (click here) following the presentation at
the 2019 ATS Conference.
About microRNA-29microRNA-29 is a
fibroblast-enriched miRNA family that is downregulated in fibrotic
diseases, including IPF in humans, thereby leading to a coordinate
increase of many extracellular matrix genes. microRNA-29 family
targets multiple extracellular matrix proteins and profibrotic
molecules. Remlarsen, a first-generation microRNA-29 mimic, has
been observed to prevent fibrotic activity in human skin but is not
optimized for systemic delivery.
About miRagen Therapeutics, Inc.miRagen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
discovering and developing proprietary RNA-targeted therapies with
a specific focus on microRNAs and their role in diseases where
there is a high unmet medical need. miRagen has three clinical
stage product candidates, cobomarsen, remlarsen, and MRG-110.
miRagen’s clinical product candidate for the treatment of certain
cancers, cobomarsen, is an inhibitor of microRNA-155, which is
found at abnormally high levels in malignant cells of several blood
cancers, as well as certain cells involved in inflammation.
miRagen’s clinical product candidate for the treatment of
pathological fibrosis, remlarsen, is a replacement for microRNA-29,
which is found at abnormally low levels in a number of pathological
fibrotic conditions, including cutaneous, cardiac, renal, hepatic,
pulmonary and ocular fibrosis, as well as systemic sclerosis.
MRG-110, an inhibitor of microRNA-92, is being developed under a
license and collaboration agreement with Servier for the treatment
of heart failure and other ischemic disease. In addition to these
programs, miRagen is developing a pipeline of preclinical product
candidates. The goal of miRagen’s translational medicine strategy
is to progress rapidly to first-in-human studies once it has
established the pharmacokinetics, pharmacodynamic, safety and
manufacturability of the product candidate in preclinical studies.
For more information, please visit www.miragen.com.
For information on clinical trials please visit
www.clinicaltrials.gov.
Note Regarding Forward-Looking StatementsThis
press release may contain forward-looking statements that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release other than
statements of historical fact, including statements regarding
miRagen’s strategy, future operations, future financial position,
future revenue, projected expenses, prospects, plans and objectives
of management or the expected features of or potential indications
for miRagen’s product candidates are forward-looking statements.
The words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,”
“opportunity,” “goals,” or “should,” and similar expressions are
intended to identify forward-looking statements. Such statements
are based on management’s current expectations and involve risks
and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation: that
miRagen has incurred losses since its inception, and anticipates
that it will continue to incur significant losses for the
foreseeable future; future financing activities may cause miRagen
to restrict its operations or require it to relinquish rights;
miRagen may fail to demonstrate safety and efficacy of its product
candidates; miRagen’s product candidates are unproven and may never
lead to marketable products; miRagen’s product candidates are based
on a relatively novel technology, which makes it difficult to
predict the time and cost of development and of subsequently
obtaining regulatory approval, if at all; miRagen’s product
candidates may cause undesirable side effects or have other
properties that could delay or prevent the regulatory approval; and
the results of miRagen’s clinical trials to date are not sufficient
to show safety and efficacy of miRagen’s product candidates and may
not be indicative of future clinical trial results.
miRagen has based these forward-looking statements largely on
its current expectations and projections about future events and
trends. These forward-looking statements are subject to a number of
risks, uncertainties and assumptions, including those described
under the heading “Risk Factors” in miRagen’s Annual Report on Form
10-K and subsequent periodic reports filed with the Securities and
Exchange Commission. Moreover, miRagen operates in a very
competitive and rapidly changing environment. New risks emerge from
time to time. It is not possible for its management to predict all
risks, nor can it assess the impact of all factors on its business
or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in
any forward-looking statements it may make. In light of these
risks, uncertainties and assumptions, the future events and trends
discussed in this press release may not occur and actual results
could differ materially and adversely from those anticipated or
implied in the forward-looking statements. miRagen undertakes no
obligation to revise or publicly release the results of any
revision to such forward-looking statements, except as required by
law. Given these risks and uncertainties, readers are cautioned not
to place undue reliance on such forward-looking statements. All
forward-looking statements are qualified in their entirety by this
cautionary statement.
Investor/Media Contact:Adam Levy, Chief
Business Officer(720) 407-4595alevy@miragen.com
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