Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage
biopharmaceutical company pursuing novel therapeutics for
nonalcoholic steatohepatitis (NASH), today announced five health
economics abstracts being presented at the NASH-TAG Conference,
taking place from January 4-6, 2024 in Park City, Utah.
Jesse Fishman, Senior Director, Health Economics and Outcomes
Research at Madrigal, stated, “We are gaining important new
insights about the serious risks and complications associated with
uncontrolled NASH through analyses of real-world data from patient
registries and health system databases. The abstracts being
presented at NASH-TAG underscore the relationship between NASH
progression and adverse patient outcomes, reinforce previous
evidence suggesting NASH independently contributes to
cardiovascular risk, and indicate that many patients with NASH are
not being monitored at the frequency recommended by clinical
guidelines. These analyses also suggest opportunities to improve
care through noninvasive testing strategies and a more holistic
approach to assessing cardiovascular risk in patients with
NASH.”
Bill Sibold, Chief Executive Officer of Madrigal, stated,
“Madrigal’s health economics outcomes research efforts are part of
a long-term strategy to provide healthcare decision-makers with
data and insights to improve patient care and contextualize the
potential value of resmetirom as a foundational therapy for
patients with NASH. The serious burden of uncontrolled NASH on
patients and the health system is coming into focus: as the disease
progresses to cirrhosis, patients face markedly elevated risk of
liver-related and cardiovascular outcomes. This is why it is
essential to treat NASH with significant fibrosis before patients
progress to cirrhosis.”
A summary of the health economics outcomes research abstracts
being presented at NASH-TAG follows:
Abstract #21: “Non-invasive tests as a prediction tool
to assess MASH resolution score” [Presenter: Jesse
Fishman]In an evaluation of biopsy and noninvasive test
data from patients included in the TARGET-NASH registry, the
FibroScan-AST score (FAST), FibroScan vibration-controlled
transient elastography (VCTE), and the aspartate
aminotransferase-to-platelet ratio index (APRI) demonstrated a
strong ability to predict NASH resolution. Overall, patients
without NASH resolution had larger baseline median FIB-4 (1.7 vs.
1.4, p<0.003), APRI (0.7 vs. 0.5, p<.0001) and VCTE (12.5 vs.
8.4, p=0.0054) scores. Sequential testing with two or three
noninvasive tests helped reduce indeterminate results.
Abstract #25: “Characterizing the management of patients
with NASH (with versus without cirrhosis) in real-world clinical
practice – Low utilization of gastroenterology and hepatology
specialty care” [Presenter: Michael Charlton]In a review
of patient records from an Optum database, researchers found that a
substantial proportion of patients with NASH were not assessed by a
gastroenterologist or hepatologist at the frequency recommended in
medical guidelines, even when diagnosed with cirrhosis. Among
patients with cirrhosis, ≥25% were not seen by a specialist at the
recommended frequency of once per year. Among those without
cirrhosis, ≥50% were not assessed by a specialist at the
recommended frequency of every 2-3 years. Screening for
hepatocellular carcinoma for most patients with cirrhosis occurred
less than the recommended frequency. The findings suggest a need to
improve clinical practice to align with clinical guidelines.
Abstract #26: “Characterizing the real-world clinical
outcomes of patients with NASH without cirrhosis versus with
cirrhosis” [Presenter: Michael Charlton]In another review
of patient records from an Optum database, researchers examined the
relationship between NASH disease progression and risk of clinical
outcomes. For patients with NASH without cirrhosis at baseline, the
risk of experiencing all-cause death, progression to cirrhosis or
decompensated cirrhosis, or a liver transplant increased from 10.5%
in year one to 31.4% by year five. The risk of death was
several-fold higher for those with cirrhosis. This study also found
that the risk of death and progression increased significantly with
age and presence of comorbidities of cardiovascular disease and
type 2 diabetes, highlighting the importance of delaying liver
disease progression.
Abstract #27: “A longitudinal assessment of
cardiovascular risk for patients enrolled in TARGET-NASH”
[Presenter: Jesse Fishman]In an analysis of patient data
from the TARGET-NASH registry, patients with NASH with cirrhosis
were found to be at an increased risk of cardiovascular events
compared to patients with noncirrhotic NASH, even after adjusting
for traditional cardiovascular risk factors: this finding supports
the notion that the severity of liver disease impacts the level of
cardiovascular risk and suggests that treatments that could delay
progression to cirrhosis may potentially reduce health events like
cardiovascular outcomes, morbidity, and mortality in patients with
NASH.
Abstract #41: “Enhancing ASCVD Risk Prediction in
NASH/NAFLD Patients” [Presenter: Jesse Fishman]In an
analysis of a retrospective dataset from a large U.S. integrated
delivery network health system, researchers compared observed
events to a model that predicted events and found that a
cardiovascular risk model that included liver-specific biomarkers
improved the prediction of cardiovascular mortality and myocardial
infarction events in patients with NASH relative to the American
Heart Association's Atherosclerotic Cardiovascular Disease Risk
Estimator Plus. This finding underscores the necessity of
revisiting current cardiovascular risk models for patients with
NASH to incorporate more holistic and liver-specific variables.
About NASH
Nonalcoholic steatohepatitis (NASH) is a more advanced form of
nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause
of liver related mortality and an increasing burden on healthcare
systems globally. Additionally, patients with NASH, especially
those with more advanced metabolic risk factors (hypertension,
concomitant type 2 diabetes), are at increased risk for adverse
cardiovascular events and increased morbidity and mortality.
Once patients progress to NASH with significant fibrosis
(consistent with F2/F3), the risk of adverse liver outcomes
increases dramatically. NASH is rapidly becoming the leading cause
of liver transplantation in the U.S. There are currently no
FDA-approved therapies available for the treatment of NASH.
NASH is also known as “metabolic dysfunction-associated
steatohepatitis (MASH)” following a change in disease nomenclature
introduced by hepatology medical societies in 2023.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a
clinical-stage biopharmaceutical company pursuing novel
therapeutics for nonalcoholic steatohepatitis (NASH), a liver
disease with high unmet medical need. Madrigal’s lead candidate,
resmetirom, is a liver-directed THR-β agonist oral therapy that is
designed to target key underlying causes of NASH. For more
information, visit www.madrigalpharma.com.
Forward Looking Statements
This communication includes “forward-looking statements” made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, that are based on Madrigal’s beliefs
and assumptions and on information currently available to it, but
are subject to factors beyond its control. Forward-looking
statements reflect management’s current knowledge, assumptions,
judgment and expectations regarding future performance or events.
Forward-looking statements include: all statements that are not
historical facts; statements referenced by forward-looking
statement identifiers, including the examples in the paragraph
below; the relationship between NASH progression and adverse
patient outcomes; the estimated clinical burden of uncontrolled
NASH; analyses for patients with NASH with significant fibrosis
concerning potential progression to cirrhosis, decompensated
cirrhosis, liver transplant or death, and cardiovascular risks,
comorbidities and outcomes; health economics assessments or
projections; resmetirom’s potential to be the first specialty
therapy for NASH patients with significant liver fibrosis;
projections or objectives for obtaining accelerated or full
approval for resmetirom, including all statements concerning
potential clinical benefit to support accelerated approval and/or
potential approval; and statements or references concerning - the
potential efficacy and safety of resmetirom for noncirrhotic NASH
patients and cirrhotic NASH patients, possible or assumed future
results of operations and expenses, business strategies and plans
(including ex-US. Launch/partnering plans), research and
development activities, and the timing and results associated with
the future development of resmetirom, the timing and completion of
projected future clinical milestone events, including enrollment,
additional studies, top-line data and open label projections,
plans, Madrigal’s primary and key secondary study endpoints for
resmetirom and the potential for achieving such endpoints and
projections, the potential to support an additional indication for
resmetirom in patients with well-compensated NASH cirrhosis,
optimal dosing levels for resmetirom, projections regarding
potential NASH or NAFLD and potential patient benefits with
resmetirom, including future NASH resolution, safety, fibrosis
treatment, cardiovascular effects, lipid treatment, and/or
biomarker effects with resmetirom, and strategies, objectives and
commercial opportunities, including potential prospects or
results.
Forward-looking statements can be identified by terms such as
“accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,”
“believes,” “can,” “confidence,” “continue,” “could,”
“demonstrates,” ”design,” “estimates,” “expectation,” “expects,”
“forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,”
inform,” “intended,” “intends,” “may,” “might,” “on track,”
“planned,” “planning,” “plans,” “positions,” “potential,” “powers,”
“predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,”
“will achieve,” “will be,” “would” or similar expressions and the
negatives of those terms.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to: the assumptions
underlying the forward-looking statements; risks of obtaining and
maintaining regulatory approvals, including, but not limited to,
potential regulatory delays or rejections; risks associated with
meeting the objectives of Madrigal’s clinical studies, including,
but not limited to Madrigal’s ability to achieve enrollment
objectives concerning patient numbers (including an adequate safety
database), outcomes objectives and/or timing objectives for
Madrigal’s studies; any delays or failures in enrollment, and the
occurrence of adverse safety events; risks related to the effects
of resmetirom’s mechanism of action; the achievement of enrollment
objectives concerning patient number, safety database and/or timing
for Madrigal’s studies; enrollment and trial conclusion
uncertainties; market demand for and acceptance of our products;
the potential inability to raise sufficient capital to fund ongoing
operations as currently planned or to obtain financings on terms
similar to those arranged in the past; the ability to service
indebtedness and otherwise comply with debt covenants; outcomes or
trends from competitive studies; future topline data timing or
results; our ability to prevent and/or mitigate cyber-attacks,
unauthorized exfiltration of data or other security incidents; the
risks of achieving potential benefits in studies that includes
substantially more patients, and patients with different disease
states, than prior studies; the timing and outcomes of clinical
studies of resmetirom; the uncertainties inherent in clinical
testing; and uncertainties concerning analyses or assessments
outside of a controlled clinical trial. 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
submissions filed with the U.S. Securities and Exchange Commission,
or SEC, 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. Madrigal
specifically discusses these risks and uncertainties in greater
detail in the sections appearing in Part I, Item 1A of its Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the SEC on February 23, 2023, as amended by our Form 10-K/A
filed with the SEC on March 3, 2023, and Part II, Item 1A of its
Quarterly Reports on Form 10-Q for the quarters ended June 30, 2023
and September 30, 2023, and as updated from time to time by
Madrigal’s other filings with the SEC.
Investor Contact Alex Howarth, Madrigal
Pharmaceuticals, Inc., IR@madrigalpharma.com
Media ContactChristopher Frates, Madrigal
Pharmaceuticals, Inc., media@madrigalpharma.com
Madrigal Pharmaceuticals (NASDAQ:MDGL)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Madrigal Pharmaceuticals (NASDAQ:MDGL)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024