Madrigal Pharmaceuticals (NASDAQ:MDGL), a clinical-stage
biopharmaceutical company pursuing novel therapeutics for fatty
liver diseases, announces its support of the Fatty Liver
Foundation, the leading patient advocacy organization focused on
the diagnosis, treatment and support of Americans with
non-alcoholic fatty liver disease (NAFLD), including non-alcoholic
steatohepatitis (NASH). Today, Madrigal and the Fatty Liver
Foundation will ring the Nasdaq closing bell to raise awareness of
the need for more evidence-based screening and testing to improve
diagnosis and staging of NAFLD/NASH.
NAFLD is estimated to afflict more than 16 million Americans.
NASH is the more severe form of NAFLD. There are more than 5
million NASH patients with significant fibrosis in the U.S. Once
NASH progresses to significant liver fibrosis, the risk of adverse
liver outcomes increases dramatically. In fact, NASH is currently
the leading cause of liver transplants in the U.S. Additionally,
patients with NASH and/or advanced fibrosis, as well as NAFLD
patients with concomitant type 2 diabetes, are at high risk for
adverse cardiovascular events and increased mortality.
Paul Friedman, CEO of Madrigal said, “In recognition of Liver
Awareness Month, we want to highlight the high unmet need of the
millions of Americans who suffer from NAFLD and NASH. NASH is known
as a ‘silent disease’ because many people don’t know they have it
until it has progressed to a dangerous stage. By supporting FLF,
our objective is to improve the medical and patient community’s
understanding of the disease, better identify NAFLD/NASH patients,
and communicate the growing body of clinical evidence demonstrating
the utility of non-invasive tools and techniques to screen and
diagnose patients.”
Madrigal is providing an unrestricted grant to support FLF’s
NAFLD Screening Fund whose primary objective is to scale-up
evidence-based screening and testing for NAFLD in a community
setting. These efforts would support, and potentially boost, the
non-invasive screening needed to identify asymptomatic disease and
diagnosing NAFLD/NASH patients at various points of
progression.
Wayne Eskridge, Co-Founder and CEO of FLF, added, “In
partnership with industry, advocates and affected communities, we
are launching the NAFLD Screening Fund, a public private
partnership with the goal of further investigating the findings
from our SUNN-1 Study (Screening for Undiagnosed NAFLD and NASH).
In this study, we identified a cohort of people who sought to
assess their risk of NAFLD and NASH through non-invasive testing,
ultimately demonstrating a high incidence of unidentified liver
pathology. We are grateful for Madrigal’s support, which will
contribute to our collective effort to identify and guide patients
in need.” Eskridge also noted, “The fund will seek collaboration
with local patient-focused organizations to facilitate the outreach
and education goals of FLF through collective action. We encourage
any interested parties to join us in this important outreach.”
Meena Bansal, M.D., Fellow of the American Association for the
Study of Liver Diseases (FAASLD) and Professor of Medicine at the
Icahn School of Medicine at Mount Sinai noted, “NASH is an
asymptomatic disease that increases the risk of hepatic failure and
cancer as it progresses. Incorporating non-invasive, evidence-based
screening and diagnostic approaches is paramount to catching the
disease in patients sufficiently early so that behavior
modifications and therapeutic care can help improve their health
and clinical outcomes.”
The Nasdaq closing bell ceremony will begin at approximately
3:45 p.m. ET on Monday, October 4, 2021, and can be viewed live
at https://livestream.com/accounts/27896496/events/9807812.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a
clinical-stage biopharmaceutical company pursuing novel
therapeutics that target a specific thyroid hormone receptor
pathway in the liver, which is a key regulatory mechanism common to
a spectrum of fatty liver and cardio-metabolic diseases with high
unmet medical need. Madrigal’s lead candidate, resmetirom, is a
first-in-class, orally administered, small-molecule,
liver-directed, thyroid hormone receptor (THR)-β selective agonist
that is currently in two Phase 3 clinical studies, MAESTRO-NASH and
MAESTRO- NAFLD-1, designed to demonstrate multiple benefits in NASH
(non-alcoholic steatohepatitis) patients. For more information,
visit www.madrigalpharma.com.
About the Fatty Liver Foundation
The Fatty Liver Foundation is the only national,
non-profit patient organization dedicated to improving
the identification, diagnosis, treatment & support of Americans
with fatty liver, NAFLD or NASH through awareness, screening,
education and patient outreach. FLF’s goal is to improve
the lives of both asymptomatic and diagnosed patients by
raising awareness, developing wellness screening, educating
patients and championing the development of a responsive support
system for individuals of the growing epidemic of fatty liver
disease. For more information,
visit www.fattyliverfoundation.org.
About the Fatty Liver Foundation NAFLD Screening
Fund
With recent advancements in the diagnostics and potential
treatments for NAFLD, screening and testing are now the critical
nexus between identification of disease and effective intervention.
To meet this need, the NAFLD Screening Fund’s primary objective is
to scale-up evidence-based screening and testing for NAFLD. Funded
activities would boost the screening practices needed to identify
asymptomatic disease and staging of NAFLD/NASH patients.
The expansion of screening and staging of fatty liver disease is
a model of community outreach that has been proven by FLF in
medical and non-medical settings. The Fund’s impact will be
expanded education and awareness of NAFLD, achieved through
screening, which has been shown to empower individuals’ ownership
and participation in their health and healthcare. Through multiple
site collaborations, new screening technologies, improved data
management systems, and more trained personnel, the Fund will be
leveraged to rapidly scale up community screening efforts. The
NAFLD Screening fund will be the catalyst for greater patient
engagement in research and development, including treatment
preparedness as new therapies become available. It is a mechanism
through which many streams of financial support, both public and
private, can be coordinated and focused on this rapidly growing
health threat.
Forward-Looking Statements
This communication contains “forward-looking statements” made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, that are based on our beliefs and
assumptions and on information currently available to us but are
subject to factors beyond our control. Forward-looking statements
include but are not limited to statements or references concerning:
our clinical trials; research and development activities; market
size estimates for NASH and NAFLD patients; the timing and results
associated with the future development of our lead product
candidate, MGL-3196 (resmetirom); our primary and secondary study
endpoints for resmetirom and the potential for achieving such
endpoints and projections; plans, objectives and timing for making
a Subpart H (Accelerated Approval of New Drugs for Serious or
Life-Threatening Illnesses) submission to FDA; optimal dosing
levels for resmetirom; projections regarding potential future NASH
resolution, safety, fibrosis treatment, cardiovascular effects,
lipid treatment or biomarker effects with resmetirom; the efficacy
and safety of resmetirom for non-cirrhotic NASH patients and
cirrhotic NASH patients; the predictive power of liver fat
reduction measured by non-invasive tests on NASH resolution with
fibrosis reduction or improvement; the achievement of enrollment
objectives concerning patient number, safety database and/or timing
for our studies; the predictive power of NASH resolution and/or
liver fibrosis reduction with resmetirom using non-invasive tests,
including the use of ELF, FibroScan, MRE and/or MRI-PDFF; the
ability to develop clinical evidence demonstrating the utility of
non-invasive tools and techniques to screen and diagnose NASH
and/or NAFLD patients; the predictive power of non-invasive tests
generally, including for purposes of diagnosing NASH, monitoring
patient response to resmetirom, or recruiting a NASH clinical
trial; potential NASH or NAFLD patient risk profile benefits with
resmetirom; the potential for resmetirom to become the
best-in-class and/or first-to-market treatment option for patients
with NASH; and our possible or assumed future results of operations
and expenses, business strategies and plans, capital needs and
financing plans, trends, market sizing, competitive position,
industry environment and potential growth opportunities, among
other things. Forward-looking statements: reflect management’s
current knowledge, assumptions, judgment and expectations regarding
future performance or events; include all statements that are not
historical facts; and can be identified by terms such as “allow,”
“anticipates,” “be,” “believes,” “continue,” “could,”
“demonstrates,” ”design,” “estimates,” “expects,” “forecasts,”
“future,” “goal,” “hopeful,” ”inform,” “intends,” “may,” “might,”
“planned”, “plans,” “positions,” “potential,” “powers,” “predicts,”
”predictive,” “projects,” “seeks,” “should,” “will,” “will be,”
“would” or similar expressions and the negatives of those terms.
Although management presently believes that the expectations
reflected in such forward-looking statements are reasonable, it can
give no assurance that such expectations will prove to be correct
and you should be aware that actual results could differ materially
from those contained in the forward- looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to: our clinical
development of resmetirom; enrollment uncertainties, generally and
in relation to COVID-19-related measures that may be continued for
an uncertain period of time or implemented; outcomes or trends from
competitive studies; future topline data timing or results; the
risks of achieving potential benefits in studies that include
substantially more patients than our prior studies; limitations
associated with early stage, non-placebo controlled study data; the
timing and outcomes of clinical studies of resmetirom; and the
uncertainties inherent in clinical testing. Undue reliance should
not be placed on forward- looking statements, which speak only as
of the date they are made. Madrigal undertakes no obligation to
update any forward-looking statements to reflect new information,
events or circumstances after the date they are made, or to reflect
the occurrence of unanticipated events. Please refer to Madrigal's
filings with the U.S. Securities and Exchange Commission for more
detailed information regarding these risks and uncertainties and
other factors that may cause actual results to differ materially
from those expressed or implied. We specifically discuss these
risks and uncertainties in greater detail in the section entitled
"Risk Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2020, as well as in our other filings with the
SEC.
Media Contacts
Mike Beyer on behalf of Madrigal Pharmaceuticals Phone:
312-961-2502Email: mikebeyer@sambrown.com
Henry E. Chang on behalf of Fatty Liver Foundation Phone:
917-400-8900 Email: henry@fattyliverfoundation.org
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